Separate studies conclude that since the FDA pub “black box” warnings on SSRI antidepressants that they may increase suicidal thinking, doctors are prescribing the drugs for fewer kids but are not following another FDA recommendation that those receiving the drugs be monitored more frequently.
The fairly sharp decline in prescribing drugs for depressed children following the FDA warnings in 2004 has been documented on several occasions, most recently in a study reported in the January 2008 Archives of General Psychiatry. There was a substantial and continuing increase in prescriptions for children from the late 1980s until the FDA warnings, leading to concern that children were being “over drugged” for mental illnesses, including ADHD and depression. The latest study, based on sampling from a large pharmacy benefit management company’s database, showed that prescriptions for antidepressants for youth were growing at a 36 percent annualized rate early in this decade, but had fallen to a negative 9 percent after the FDA warnings. Other studies have shown greater declines.
Many physicians, including leaders in the mental health field, note that adolescent suicide rates declined while prescriptions grew and are worried the pendulum has swung too far against drugs. Others are more sanguine, although more recent reports suggest a renewed growth in the suicide rate among adolescents.
But it must be a good thing that fewer children are being put on antidepressants if it is important to increase monitoring them for suicidal thinking, because another recent study indicates that the medical profession has not increased monitoring at all. In fact, the frequency of repeat visits has declined. (See thumbnail chart. Double-click on it to make it bigger.) Trends in follow-up care for both children and adults was flat or declined, according to a study reported in AJP in Advance in November 2007. The study reviewed the files of more than 27,000 pediatric patients and 193,000 adult patients in a managed care claims database who received antidepressant medications.
Psychiatrists monitored their patients with visits more frequently than did pediatricians and primary care physicians. About 80 percent of psychiatric patients were deemed to have been seen sufficiently often for followup, but only 60 percent of the patients prescribed antidepressants by pediatricians and 54 percent of those seen by primary care physicians. But none of these rates, including for the psychiatrists, was significantly greater than before the FDA recommendation.
The bottom line: Once again, the evidence shows that you, the parent, have to be an advocate for your mentally ill child to be sure he or she gets the treatment they need.
An abstract of the study on declining prescriptions can be found at The Archives of General Psychiatry and a summary story at Psychiatric News. An abstract of the study of follow-up visits is here. You can find the Psychiatric News summary story here.
Feb. 1, 2008
The suicide rate among
young persons 10-24 increased substantially from 2003-2004
after
twelve years of overall decline. The greatest increase was
among girls ages 10-19, a group that historically has been (and
remains) less prone to successful suicide than boys.
Suicide is the third leading cause of death among those aged 10-24, accounting for 4,599 deaths. Statistically, the increase coincides with tougher warnings against use of anti-depressants on children and a decline in the prescribing of such drugs for children. The statistics, provided by the Center for Disease Control in a recent report, will further fuel the intense debate over whether psychotropic drugs used to treat depression in adults are helpful or harmful to children.
The CDC identified three groups in which suicide rates rose in 2004. They were females aged 10-14 and 15-19 and males aged 15-19. The largest percentage increase -- 75.9% -- was among females aged 10-14. The rate of increase among females aged 15-19 was 32.3% and among males aged 15-19 it was 9%. The suicide rate for males ages 10-14 and 20-24 remained stable from 2003-04, but men 20-24 still are by far the most suicide-prone group, with 20.64 deaths per 100,000 in 2004. Female suicides remained a fraction of male suicides in all age groups 10-24 reported by the CDC. In absolute numbers, from 2003 to 2004 suicides increased from 56 to 94 among girls10-14, from 265 to 355 for women 15-19 and from 1,222 to 1,345 for men 15-19.
Firearms are the most common form of suicide among males. Women prefer hanging or suffocation, according to the CDC statistics. Due in large part to the increase in female suicides, the rate of use of firearms to commit suicide has declined overall since 1990 and hanging/suffocation has increased.
As the chart hyperlinked here shows, since 1990 the overall trend has been a decline in suicides among persons 24 and under, although the rate increased in some years slightly for some groups before continuing to decline. The percentage decline was most pronounced among males. The overall decline from 1990-2003 was 28.5%.
A statistical increase in suicidal thinking (not suicides) reported in studies of use by children of antidepressants such as Zoloft and Paxil, along with angry and sad testimony from parents of children who committed or attempted suicide while taking these drugs, led the FDA in 2004 to require a “black box” warning on drug packages stating that the drugs were not recommended for children under 18. The result was a decline in use of the drugs. The latest CDC data is statistical evidence proponents of therapeutic drug treatment of depression in children can cite to show that drugs can be helpful in preventing suicide. That there was only a slight increase among men and women 20-24, and thus not effected by the “black box” warning, also is evidence suggestive of the benefits of drug therapy. (The FDA extended the warnings to those up to age 24 earlier this year).
Thomas Insel, director of the National Institute of Mental Health, told The Washington Post, “We may have inadvertently created a problem by putting a ‘black box’ warning on medications that were useful.” He added, “If the drugs were doing more harm than good, then the reduction in prescription rates should mean the risk of suicide should go way down, and it hasn’t gone down at all -- it has gone up.”
The Post also reported that a study published in the American Journal of Psychiatry described a 22 percent decrease in antidepressant drug use among children in the Netherlands between 2003 and 2005 and a 49 percent increase in suicides in the same period in that country. The newspaper also noted prior studies that in countries where antidepressant use is higher, suicides are fewer, and that in a study of 200,000 depressed veterans, those taking antidepressants had one-third the risk of suicide of those who were not.
The New York Times quoted an FDA spokesman as saying that it would need to see more data over a longer time to determine if declines in prescriptions increase suicide risk. “You simply cannot reach casual conclusions from the new CDC data,” the spokesman said.
Insel told The Post that new research to be published soon examines genetic factors that may put some patients at particular risk for use of antidepressants, while those without genetic predisposition to depression might not face those risks. But he acknowledged it would be some time before physicians have tests that can reliably predict which patients are likely to become suicidal as a result of drugs. In the meantime, he said, “if I had a child with depression, I would go after the best treatment but also provide the closest monitoring.” To which The Depressed Child adds: AMEN.
Sources: Center for Disease Control, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5635a2.htm, Washington Post 9/6/07 at A-1 and New York Times 9/7/07 at A22
FDA to Makers of Adderall, Strattera and Ritalin:
Beef Up Warnings to Patients, Parents
The Federal Food and Drug Administration has told manufacturers of the principal drugs prescribed for juveniles to treat ADHD (attention deficit/hyperactivity disorder) to provide patients and parents with brochures warning in some detail of the cardiac and mental health dangers posed by these drugs. (See the FDA release and materials linked to the release at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html ). The demand for more detailed information follows by nearly a year requirements by the FDA to strengthen the labeling warnings on these issues. (See story below: Ritalin and Adderall: Black Box Warnings for Them, Too).
An FDA press release announcing the brochure requirement said "medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well." Called "Patient Medication Guides," these short brochures are handed out to patients, families and caregivers when a medicine is dispensed. They have room for more detailed information about the risks of these drugs than can be easily printed on a label and, because they are a separate document, may be more successful in drawing the patient or parent's attention to the warnings.
The drugs required to be accompanied by brochures include Adderall, Concerta, Ritalin and Strattera.
FDA review of drug studies revealed a "slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems." Although the FDA did not specifically say so, these problems were identified in adolescents and younger. This information is to be included in the brochures.
The brochures also will warn of an increased risk of cardiac problems, including sudden death, in patients with pre-existing conditions and in adults who have certain risk factors.
A review of the brochure language for Adderall, Ritalin and Strattera (the language is linked to FDA website identified above), discloses that only Strattera contains an explicit warning about increased suicidal thinking, in language nearly identical to the "black box" warnings about suicide required in antidepressant drugs. The Adderall and Ritalin warnings are more general, identifying possible "new or worse behavior and thought problems, new or worse bipolar illness and new or worse aggressive behavior or hostility."
The FDA press release estimated that ADHD affects approximately 3 to 7 percent of school-aged children and about 4 percent of adults.
Source: FDA News, 2/21/07, and pages linked to the main page. See: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html
Study: Little Correlation Between Substance Abuse and Suicide for Children 9-16; Depression With Anxiety or Opposition Disorder Strongest Indicators; Poverty Also a Factor
Substance abuse has little correlation with suicidal behavior among children ages 9-16, according to a recent study of 1,420 male and female children in western North Carolina reported in the September 2006 issue of the Archives of General Psychiatry (www.archgenpsychiatry.com). Less surprisingly, diagnosed depression is most commonly associated with suicidal thinking and suicide attempts in children, especially when it is accompanied by either general anxiety disorders (GAD) or oppositional/defiant disorder (ODD).
The study reviewed 6,670 psychiatric records of the children, who were selected based on in-home interviews conducted by trained interviewers separately with the child and the child’s parents. In 62 percent of the cases a child informed the interviewer that he/she thought about dying or suicide, or even in some cases had attempted suicide, but the parents were unaware of such thoughts. “In other words, parents were typically unaware of their child’s suicidality,” the study’s authors reported.
“Suicidal youth were 6 times more likely to have a psychiatric disorder and 22 times more likely to have multiple psychiatric disorders than were non-suicidal youth,” the authors reported.
“Anxiety, depressive and disruptive behavior disorders were all associated with a significantly increased risk of suicidality. Risk was greatest in association with depression. Drug abuse was not associated with suicidality. After controlling for all other disorders, anxiety, depression, and disruptive behavior disorders were all independently associated with suicidality. Illicit drug abuse was associated with a significantly decreased risk for suicidality.”
“There was a statistically significant interaction between depression and GAD and between depression and ODD, indicating that both co-morbidity profiles conferred a greater than expected risk for suicidality,” the authors concluded.
Among other findings:
Suicide attempts are increasing among girls age 13; Suicidal thinking increases at age 13 and later.
There is a “robust association between poverty and suicidality…” “In at-risk youth, poverty may index a vast list of potential risk factors, including abuse, trauma, social isolation or diminution of social support due to parental unemployment or illness, frequent residential moves, or the operation of other factors, that disturb familial or youth support structures.”
The report’s authors were Debra L. Foley, PhD., of the Virginia Institute for Psychiatric and Behavioral Genetics at the Medical College of Virginia; David B. Golston, PhD., Jane Costello, PhD and Adrian Angold, MRC Psych, all of the Department of Psychiatry and Behavioral Sciences, Duke University Medical Center. The authors cautioned that their study was based on a sample from a small geographic area that may not be representative of other areas of the country.
Source: Archives of General Psychiatry, Sept., 2006
More Confusion: New Study Claims Antidepressants Cut Suicide Attempts in High Risk Cases
A study of more than 65,000 patients in
The 
taking either a serotonin
selective reuptake inhibitor (“SSRI”) antidepressant, such as Prozac
or Zoloft. Separately, it made the same statistical comparison
for older types of antidepressants. The study concluded that
suicide and suicide attempt rates were quickly and significantly
reduced by the SSRIs. Suicide attempt rates were significantly
higher in the month before the patients took the SSRIs than in the
months after. They were about the same among patients taking
the older types of antidepressants, but began to fall in the second
month of treatment.
“We don’t find any evidence to support the widely held belief that suicide risk increases when people start taking antidepressant medications,” Dr. Gregory Simon, an author of the report, told Psychiatric News. “What we did find was that suicide risk actually decreases when people start taking antidepressants.”
However, it was to be expected that suicide attempts would be high immediately before beginning treatment because the attempts themselves would prompt medical treatment. In other words, the statistics identify those at highest risk, and an inference is that they received the greatest immediate benefit from SSRI treatment. But, according to the report, it took five months of treatment for suicide attempts among treated patients to decline to the levels they were two and three months before treatment began. After six months of treatment, attempted suicide rates among those taking the SSRIs were somewhat lower than they were three months before treatment began.
The statistical study, which included adults and teens, but not children, certainly seems to support pharmaceutical industry claims that SSRIs and, to a lesser extent, older antidepressant formulas, are effective in reducing the threat of suicide in high risk patients. But the data is less persuasive when it comes to patients who are not in the high risk category. Suicide attempts were higher in each of the first five months of treatment with either kind of antidepressant than in the two and three months before treatment was initiated. It is difficult to know if this means the FDA “black box” warning of increased suicidal ideation and attempt is warranted, or if the drugs are effective in a continual reduction of risk over time.
The report was funded by the National Institute of Mental Health,
not by the pharmaceutical industry. It appears in the January
issue of the American Journal of Psychiatry (click the underlined
title for a link to the article). Here is the table, as
produced in the Journal (bars indicate 95 percent confidence levels:
Sources: American Journal of Psychiatry, January 2006; Psychiatric News, 1/20/06, p. 18
Depressed Child comment:
In our view, this study should at least allay some of the worst
fears raised by various clinical (as opposed to epidemiological
statistical) studies suggesting a heightened risk of suicide from
SSRI antidepressants. We always thought the link to “cause”
was thin in such studies, and were surprised that the “experts” were
surprised that some kids taking antidepressants occasionally
entertained thoughts of suicide. That said, we also are in
favor of caution in the use of any psychotropic drugs on children
and teens. Antidepressant prescriptions to teens and children
declined 20 percent after the “black box” label was required by the
FDA. That could be good or bad in any individual case, but
statistically suggests that second thoughts are being applied to
drug treatment, which is nearly always good. The
Depression: It Really Is All In Your Head
More evidence that depression is a result of the chemistry in your brain, not something readily under conscious control. According to a report in the January 6 issue of Science, a newly discovered protein, called p11, increases the serotonin in the brain which enables efficient communication across synapses among the neurons. A reduction in serotonin has been equated with depression. Modern antidepressants such as Prozac and Adderall act to effectively increase serotonin. According to the latest study, p11 increases the ability of receptor cells to use serotonin.
Nobel Laureat Paul Greengard, a professor of psychiatry and
pharmacology and director of the Laboratory of Molecular and
Cellular Neuroscience at
The researchers examined p11 levels in post-mortem samples from the brains of depressed patients and a mice model of depression and compared the levels with those found in non-depressed humans and normal mice. Levels of p11 were found to be substantially lower in depressed humans and mice. They also tested p11 levels on mice who were treated with antidepressants and found the drugs elevated p11 levels.
“This new-found protein may provide a mores specific target for new treatments for depression, anxiety disorders and other psychiatric conditions through to involve malfunctions in the serotonin system,” Dr. Elias Zerhouni, director of the National Institutes of Mental Health (which helped fund the project) told Psychiatric News.
Source: Psychiatric News, 2/3/06 p. 18
Depressed Child comment: The evidence that depression is a result of biochemical imbalances in the brain is impressive. The evidence that current medications are effective without significant risk is less so. A question not answered: Can behavior modification, or even realigned thinking, that could result from counseling with or without drugs also alter these imbalances? While our chemical balances may be controlled by our unconscious, isn’t our unconscious also shaped by our consciousness? When we tell the brain to do something, it does so by changing a chemical balance in communication among the brain cells. Can we identify a way of doing the same thing with serotonin and other chemicals related to depression?
Depression Drug Prescriptions for
Adolescents and Kids Drop 20%
Physicians and psychiatrists are prescribing fewer antidepressant
drugs for minors since the FDA required "black box" labels warning
of increased suicide risk from taking the drugs, according to an
analysis by Psychiatric News, the newspaper of the American
Psychiatric Association (APA). The APA and the 
The FDA requirement was imposed in October 2004 (click here for
article on this page). The warning must appear on the labeling of
all antidepressant medications distributed in the
The nearly 20 percent decline in less than a year is was called "a decline whose public health consequences are unknown and must be monitored by policymakers, physicians, parents and patients," in the letter sent by the APA and AACAP to the FDA.
"This dramatic shift raises the serious questions of whether those children and adolescents with depression who are no longer taking these medications are receiving any care at all -- or are receiving the most effective care," they wrote.
The FDA told Psychiatric News when it first printed the news of the decline in prescription-writing in September 2005 that "even tracking suicidal behavior in this population is not a failsafe approach to assessing the impact of this labeling change, because secular trends in such behavior are influenced by many different factors."
The APA and the AACAP said in their letter that several studies, including at least one funded by the National Institute of Mental Health, have shown that the most effective treatment for juvenile depression is a combination of medication and counseling. The organizations observed that the prescription decline would seem to "endanger" this course of treatment.
[Click here for an essay by The Depressed Child questioning if reduction in drugs results in better or different treatment, or no treatment at all.]
Source: Psychiatric News, p. 18, 10/7/05 [Return to Headlines Page]
Mental Health Care For Children by Primary Care Givers Poor
Child psychiatrists give primary care physicians low marks for
treatment of youth with emotional disorders. According to data
presented during the annual meeting of the
According to Psychiatric News, a publication of the American Psychiatric Association, the report "provided stark contrast to numerous upbeat AACAP meeting sessions devoted to the interplay of child psychiatry with pediatrics and primary care." Some of these more "upbeat" sessions involved test programs in which child psychiatrists actively consulted with pediatricians or other primary care givers. Other presentations described what the News called "diagnosis mills" to which children are referred by primary care givers for a quick diagnostic evaluation and then referred back to the primary care giver with detailed treatment recommendations.
Other programs highlighted at the convention included efforts to place mental health specialists directly into schools to identify children with mental health issues for referral for evaluation and treatment.
The consensus reported by the News was that although there is
greater interest in making diagnosis and treatment of mental health
problems in children among professionals, educators and others,
there are still significant obstacles. The AACAP has been
working with the
Source: Psychiatric News, Dec. 2, 2005, p. 9 [Return to Headlines Page]
NIMH Survey: Half of Americans Develop a Mental Illness, Most at a Young Age;
Adds to Debate on What Is a Mental Illness
Here's some depressing news: According to a recent survey sponsored by the National Institute of Mental Health, more than half of all Americans will develop a mental illness at some point in their lives, often beginning in childhood or adolescence. One quarter of all Americans met the criteria for having a mental illness within the past year, and one-fourth of those (about 6 percent of the surveyed population) had a disorder that significantly disrupted their ability to function day-to-day. Less than half of those in need of treatment got it, and those who did seek treatment typically did so after a decade of delay during which their symptoms got worse. The treatment was usually inadequate, according to the survey.
The report concluded that younger sufferers are especially overlooked, even though mental illness is a disease of youth. Half of those who will ever be diagnosed with a mental disorder show signs of the disease by age 14, and three-quarters by age 24, but few get help, according to an article about the survey in The Washington Post.
The study was immediately questioned by some experts as defining mental illness too broadly, according to a report in The New York Times. But Dr. Thomas Insel, director of the NIMH, told reporters that "the key point to remember is that mental disorders are highly prevalent and chronic" and that the survey "demonstrates clearly that these really are the chronic disorders of young people in this country." The illness most often found to have occurred in the survey was major depression (16.6 percent of those surveyed). But the largest overall category of illness was "any anxiety disorder" (28.9 percent), including panic disorder, agoraphobia, "specific phobia" and "social phobia." Another large category included as mental illness was substance disorder (14.6 percent), including alcohol abuse (13.2 percent). Mood disorders, including depression, dysthymia (2.5 percent) and bipolar disease (3.9 percent) accounted for 20.8 percent of all mental illnesses reported.
The report was based on face-to-face interviews with a broad cross-section of 9,282 Americans ages 18 and over. According to The Times, interviewers asked the participants whether they had experienced periods of extended sadness, alcohol or drug abuse, irrational fears or a host of other symptoms. If so, the interviewers probed more pointedly about the episodes. If the symptoms described met the criteria outlined in the American Psychiatric Association's Diagnostic and Statistical Manual, Fourth Edition (DSM IV) then the respondent was classified as having experienced a mental disorder. The results were reported in a series of papers in The Archives of General Psychiatry.
Impulse control disorders, which are commonly identified in children, accounted for 24.8 percent of the past or present mental illness in the population surveyed. Oppositional-defiant disorder was reported by 8.5 percent; 9.5 percent reported "conduct disorder" and 8.1 percent reported attention deficit/hyperactivity.
There is an important debate among psychiatrists and psychologists
about whether the DSM IV identifies too many everyday emotional
struggles as "mental illness" and whether the symptoms in the DSM
are too generalized to be of use in diagnosing and treating a
patient's problems. Dr. Paul McHugh, a professor
of psychiatry at
Sources: The Washington Post, p. A3; The New York Times, p. A17, both June 7, 2005 [Return to Headlines Page]
Study Pursues Genetic Link to Depression
It has long been supposed that there is a genetic predisposition to depression, often reflected by family histories of "self-medication" such as alcoholism and drug addiction, or simply a line of relations who exhibit symptoms of depression. Now scientists in North Carolina have discovered a genetic variation that could account for this predisposition. The findings were posted in December 2004 in the on-line edition of the journal Neuron and reported in several newspapers.
Biologists at 
antidepressants operate to cause serotonin to, in effect, remain
active to better complete the communications between the neurons.
That is why they are called "selective serotonin reuptake
inhibitors" (SSRIs). Zoloft and Prozac, among others, are in
this category of drugs.
The Duke team tested for the variation in the gene in 87 people diagnosed with depression. They found that 10 percent of the sample had the mutation. Fewer than one percent of a comparison group that was not diagnosed with depression had the mutated gene. This is deemed a significant correlation. The researchers caution that if depression is sometimes a result of genetic predisposition, more than one gene likely is involved in a complex process that is poorly understood.
"The results need to be replicated, but they suggest that we may be able to personalize the treatment of depression," Dr. Thomas Insel, director of the National Institute of Mental Health, which helped finance the study, told The New York Times. "We might be able to predict, based on the presence of this gene variation, whether someone will respond to certain antidepressants."
Source: The New York Times, 12/10/04, p. A 36.
Whom Do You Trust: Prozac Beats Talk, Says Government Study
A study financed by the
These agencies vary their views almost as often as the weather. It should be noted that the FDA also approved Prozac for treatment of youth depression before it warned against use of such antidepressants for children. A story about the FDA warning is below. The British have banned use of all antidepressants except Prozac for persons under 18. In May 2002, NIMH reported that talk therapy is at least as effective as SSRIs. In that case, the study was co-sponsored by the manufacturers of Paxil, another SSRI, and compared only Paxil and therapy. That study did not focus on teenagers, however, and Elliot Spitzer, the New York State attorney general, has sued the manufacturers of Paxil for withholding information about its effectiveness with children.
According to NIMH, the Prozac study was the first to compare psychotherapy and drug treatment for depressed adolescents. It does lend further weight to contentions that, among all the antidepressants, Prozac has performed best in trials with children.
According to a report on the latest NIMH study by The New York Times, researchers found talk therapy by itself no more effective in reducing depression than treatment with placebos. "But when combined with drug treatment, psychotherapy appeared to provide added benefit and to reduce the risk of suicide," The Times reported.
The Times quoted Dr. Graham Emslie, a professor of psychiatry at the
"Despite the popular belief that they are all the same," Dr. Pies continued, "these drugs . . . . have important neurochemical differences." He also warned that antidepressants such as Prozac are not appropriate medications for victims of bipolar disease, which shares many traits with depression.
The NIMH study involved 439 youths ages 12 to 17 who were suffering from moderate to severe depression. These youth were randomly assigned to four groups for 36 weeks of treatment. The test subjects were provided (1) Prozac, manufactured by Eli Lilly & Company; (2) the most common form of talk therapy, cognitive behavioral therapy; (3)a placebo or (4) a combination of Prozac and talk therapy. The NIMH report was based on analysis of data for only the first 12 weeks of treatment completed by 378 subjects. The mean age was 15.
According to The Times report, based on one measurement scale for depression, the researchers found that after 12 weeks, 71 percent of the subjects who received both Prozac and talk therapy responded well, compared with 61 percent who received Prozac alone, 43 percent of those who received talk therapy alone and 35 percent of those who received a placebo treatment. By another measure of depression, talk therapy alone "fared no better than treatment with placebos," according to The Times summary.
All patients became less suicidal, no matter what their treatment, including with placebos, but there were five suicide attempts among those given Prozac and just one among other participants.
Another study delivered at the conference and reported by The Times suggested that another SSRI, Zoloft, was less effective than talk therapy for treatment of obsessive/compulsive disorder. Those who received talk therapy did better than those receiving Zoloft.
Sources: The New York Times, 6/2/04, p. A1 and 6/5/04, p. A24 (Letters to Editor).
Scientists Find Gene Linked to Depression
Scientists have suspected for many years that chronic depression -- the kind that occurs with no evident causal event in life -- may be an inherited genetic disorder. But the evidence has been indirect. Now, the same research group that identified the genes responsible for some breast cancers claims to have identified a gene that causes depression.
Myriad Genetics, Inc.,
Abbott Laboratories has joined with Myriad to develop drugs based on the genetic discoveries. Abbott cautioned that "this is an early-stage discovery, but we are excited that we have opened a new pathway to attack depression."
Myriad said the DEP1 gene acts in a "novel pathway, not previously known to be involved the cause of depression, and may lead to a novel class of anti-depressive therapeutics." Myriad claimed the "pathway" is different from the path used by Selective Serotonin Reuptake Inhibitors (SSRIs) which are now considered the best combination of effectiveness with minimal side effects used to treat depression. SSRIs include Zoloft, Prozac and Paxil. Myriad noted in its press release announcing the gene discovery that SSRIs can take up to six weeks to provide relief. The Wall Street Journal noted in an article announcing the discovery that some patients do not respond well to SSRIs.
The Journal article said that "about 30% of depression patients
don't improve with existing drugs, and as many as 50% still suffer
some depression symptoms despite medication. Of the roughly
30,000 suicides in the
In addition to working with Abbott on new drugs to treat genetically-based depression, Myriad said it is "pursing a predictive medicine product" to identify at-risk individuals so that they can take preventative measures to avoid depression.
Abbott told the Journal that it would be 18 months to three years before the company could begin clinical trials in human patients based on the discovery of a "depression gene."
[Depressed Child Note: Parents should take heed that there is only one immediately practical effect on the possible treatment of your own child: This is reason to be even more skeptical of mental health care givers who immediately rule out a physical cause of your child's depression. Especially where there has been no evident event to "cause" depression -- divorce, death, serious mistreatment by fellow students or playmates -- ruling out drug therapy even for children can be very shortsighted and dangerous. Unfortunately, it is unlikely any drug to address genetically based depression will be available until your youngster is an adult, or nearly so.]
Sources: Myriad Genetics Inc. press release, 2/4/03; The Wall Street Journal, 2/5/03, p. B1.
More in College Seek Help for Deeper Psychological Problems
Add college students to the list of those needing care for deeper
and more difficult psychological problems. A new study from
the counseling center at
The number of students showing suicidal ideation also nearly doubled, to 9 percent in 1996-01. Grief treatment more than doubled to 10 percent of patients seen, while developmental problems -- which cover a range of behaviors and symptoms, including separation from parents, anxiety over romantic relations, etc. -- more than doubled, to 41 percent of patients in 1996-01. (Obviously, many patients of the clinic showed symptoms of multiple mental health problems).
The center's study was published in the journal Professional Psychology Research and Practice.
In a separate survey referenced by The New York Times, more than 80
percent of 274 directors of counseling centers said they thought the
number of students with severe psychological disorders had increased
over the previous five years. The survey was conducted in
2002. The Times quoted Dr. Robert Portnoy, the director of
counseling and psychological services at the
Doris Bertocci, a social worker at
Perhaps not surprisingly, given the increased number and severity of mental illness reported, use of prescribed psychotropic medications also increased at the KSU counseling center. While only 9 percent of patients used such medications in 1988-92, 22 percent reported using them in the 1996-01 time period.
Source: The New York Times, Feb. 3, 2003, p. A-11
Anger and Depression Linked to Same Cause:
Serotonin Reduction
Often childhood depression is accompanied by unusual temper tantrums, defiance and opposition by the child against parents, although may not be demonstrated against other adults, such as teachers. There is evidence that these symptoms of depression and defiance may arise from the same source: low levels of serotonin in the brain.
A recent article in the New York Times health section (Nov. 12, 2002, p. D5) by a medical doctor, Richard A. Friedman, describes how some people are genuinely unable to control rage because of damage to the brain or abnormal brain function. Though he says most people with bad tempers can be helped with anger management and self-control, such treatments are more problematic for those with low serotonin.
The article quotes a
Dr. Friedman writes: "What is interesting is that impulsive aggressive behavior is also tightly linked to the neurotransmitter serotonin. Researchers have found that some violent and impulsive patients have significantly lower levels of brain serotonin compared with normal people in control groups. That is probably why serotonin reuptake inhibitors like Prozac and Zoloft, which enhance serotonin function, have an anti-aggressive effect and are useful in treating violent criminals as well as patients prone to rage who also suffer from ailments like depression or personality disorders."
Depressed Child note: This article was not addressed to childhood illness, but there is no reason this site knows of why serotonin dysfunction cannot also be a factor in childhood symptoms. This is more evidence that proper treatment of childhood depression requires serious consideration of both counseling and pharmacological solutions.
Source: The New York Times, Nov. 12, 2002, p. D5
NIMH Study: Therapy Works as Well as Drugs for Depression
A study funded in part by the maker of Paxil concludes that cognitive therapy is as effective as drugs for treating severe depression.
The study, funded by the National Institute of Mental Health
and GlaxoSmithKline, PLC (which makes the antidepressant Paxil),
were presented at the annual meeting of the American Psychiatric
Association in
Researchers at the
The psychotherapy sessions were intended to coach patients to see that their thoughts of worthlessness and hopelessness are exaggerated.
After two months, 50 percent of the medicated patients had improved, as measured by a standard scale of depression. So had 45 percent of the patients receiving only cognitive therapy. Only 25 percent of the placebo patients reported getting better.
The Wall Street Journal, which reported on the study, noted that the results are counter to those of an earlier NIMH study. In 1989, that trial concluded that although therapy is as effective as drugs for mild depression, it is much less effective for the moderate-to-severe kind.
[Comment by The Depressed Child: The article reporting on this survey said nothing specific about childhood depression. We wonder if children are much less conversational or able to absorb two hour doses of therapy involving concepts such as exaggerated feelings of hopelessness. Also, we are continually skeptical of surveys in which patients are asked to judge the effectiveness of their treatment via “standard scales.” Based on such self-evaluation, in the last few weeks we have had studies reporting that drugs were no better than placebos and this study reporting that drugs were twice as effective as placebos. Plus, we have NIMH studies contradicting themselves, as described above. Our view is that counseling can be helpful, but that children at risk also need a thorough psychiatric evaluation with possible drug treatment. Kids change for better or worse much faster than a therapist can keep track of them! End our comment.]
Article source: The Wall Street Journal, p. B1, May 24, 2002
Parents' Verbal Abuse Can Bring Long-Lasting Psychological Damage
A report by the
Johnson's research breaks psychological abuse into five categories, according to an article in The Washington Post. These include terrorizing (often by threatening physical abuse), exploiting or corrupting (including putting children in inappropriate situations or even expecting too much of them), denying personal responsiveness (such as rejecting or isolating a child on unreasonably restricting a child's freedom).
The Post quotes Johnson as saying, "We have so much focus on physical and sexual things, but things we can't see can be much more damaging and may never heal."
Source: The Washington Post Health Section, p. F5, May 14, 2002
Study: Boys and Girls Show Different ADHD Symptoms
A study reported in the January issue of the American Journal of Psychiatry of 280 children diagnosed with ADHD suggests that girls with ADHD are more likely than boys to have the predominantly inattentive type of ADHD (i.e., without the hyperactivity), less likely to have learning disabilities and less likely to manifest problems in school or in their spare time. In addition, girls with ADHD were less at risk for co morbid major depression, conduct disorder and oppositional-defiant disorder than boys with ADHD. ADHD Boys also may be more likely to be substance abusers.
The study included 140 boys and 140 girls diagnosed with ADHD. They, along with 120 boys and 122 girls who were not diagnosed as suffering ADHD, were subjected to diagnostic interviews and a battery of tests for ADHD and emotional , school, intellectual, interpersonal and family functioning.
The authors' conclusion was that because ADHD symptoms are less evident in girls, they are referred for professional help less often than boys.
[Note from The Depressed Child: We are not signing up for the child "gender wars" on this page. All children need love and attention and all children will experience difficulties growing up. But each child must be dealt with individually. There is no common mold that automates diagnosis and treatment, and certainly not one based on gender. That said, this page continues to worry that the schools/mental health institutions are demonizing what was considered "boy" behavior. This is not to say that bullying, inappropriate joking, fighting and sexism are to be tolerated and not disciplined, but we ask the question: Is it so often mental illness? Is it so often ADHD? Or have several horrific school shootings and other events caused us to lose our perspective and -- God forbid -- even fear our male children?)
Article Source: Abstract, Journal of Psychiatry , 159:36-42, January 2002. Influence of Gender on Attention Deficit Hyperactivity Disorder in Children Referred to a Psychiatric Clinic. Biederman, Mick, Faraone, Braaten, Doyle, Spencer, Wilens, Frazier and Johnson.
Is the DSM-IV Framework Appropriate for Diagnosis of Preschoolers?
DSM-IV, the diagnostic "Bible" of the mental health profession, contains a list of identifiable symptoms of depression (See the Symptoms page on this website). Although the DSM makes observations and distinctions between adults and children and adolescents -- and still is difficult to apply -- it is not clear if these clinical symptoms are applicable to pre-schoolers. "It is debatable whether behavioral problems in young children should be considered within a diagnostic framework at all, since normative behavioral disruption occurs during the preschool period," write Kate Keenan and Lauren S. Wakschlag in the March issue of The American Journal of Psychiatry.
Keenan and Wakschlag compared different approaches to diagnosis of disruptive behavior in young children and examined evidence to assess the validity of DSM-based characteristics of oppositional defiant disorder and conduct disorder in preschool children. Although this work is being used to outline an agenda for further study, Drs. Keenan and Wakschlag conclude that the DSM model is useful for distinguishing between typical and atypical behavior problems, but care must be taken to address the child's developmental level. They conclude that "empirical investigation is needed to standardize modification of existing assessment tools so that they can be used with preschool children and to develop more clinically sensitive methods for using observational data" to assess a child's mental health in the context of preschool development.
Source: Abstract, The American Journal of Psychiatry, 159:351-358, March 2002. "Can a Valid Diagnosis of Disruptive Behavior Disorder be Made in Preschool Children?" Keenan, Kate, PhD. and Wakschlag, Lauren S., PhD. [Return to Headlines Page]
Sugar Pills as Good as Antidepressants?
Sugar pills may be as effective as high-priced prescription anti-depressants such as Prozac, Zoloft and Paxil, according to a new analysis. All seem to cause changes in the same area of the brain, adding fuel to arguments that to a great extent the idea of taking a drug cure is about as good as actually receiving the pill.
The placebo effect is well-known in many areas of medicine, but the latest analysis suggests that for patients suffering from depression, it acts on the brain in about the same fashion as expensive drugs. (See the story immediately below based on another study suggesting that neither Zoloft nor St. Johns Wort are especially effective in treating depression).
Kahn analyzed trials that were made public in medical literature, which tend to show positive results according to the Post article, and those that were not.
In another study published in the January edition of the American Journal of Psychiatry written by Andrew Leucter, a professor of psychiatry at UCLA and also reported in the Post, brain changes associated with selective serotonin reuptake inhibitors (SSRIs such as Zoloft and Prozac) often were in the same part of the brain in which placebos also showed an effect. Thirty-eight percent of the patients responded to the placebo with heightened activity in the frontal lobe of the brain and 52 percent of patients taking SSRIs also showed heightened activity in the frontal lobe.
The Post reported reactions of several psychiatrists and psychologists who cited results of the study as support for the need for patients suffering from depression to obtain counseling, and not just rely on dispensation of pills by a general practice physician.
[Depressed Child Note: The philosophy of this web site is that parents who suspect their child suffers from mental illness should learn as much as they can about the relevant illness -- in the case of this site, depression -- so they can speak intelligently with mental health professionals, challenge them if necessary, and feel more confident about what their instincts tell them about their kids. The above article proves the wisdom of using, but not surrendering to, the mental health profession.
Among other things, there is a continuing battle between the drug-oriented MDs, including psychiatrists, and the Ph.D./M.S. group -- psychologists, social workers and other counselors not permitted to prescribe drugs. The former point to numerous studies which purport to show the positive impact of drugs, including SSRIs. That many people now take them and find them helpful suggests they may be more useful than the above report concludes. The non-MD counselors always argue strongly for the benefits of counseling, sometimes denigrating the value of drug treatment.
Unfortunately, it is not easy to truly test the value of drugs and it is nearly impossible to evaluate counseling effectiveness in a controlled study. As the tests for depression and ADHD found elsewhere on this web site show, even recognizing symptoms of depression can be difficult, since many of those symptoms may also at least temporarily be experienced by those who don't suffer serious depression. Determining who is "sick" and who is getting "better" is highly subjective, relying on the impressions of the patient, even in the best of tests. Effective counseling depends on the nature of the illness, the personality and training of the counselor, the personality of the patient and perhaps even matters as subjective and difficult to measure as the surroundings of the office. The non-M.D. group has the advantage of counseling being virtually non-testable for effectiveness on a large population of patients, at least as compared to the more controlled (but hardly perfect) testing of drugs.
The Depressed Child is only concerned with this "battle" to the extent that parents should be aware of it in assessing the various treatment options for their children. You should know the vested interests involved in this fight. It is disheartening that the field of mental health contains so many basic issues that are unanswered. The best approach is to learn as much as you can, don't arbitrarily rule out anything that seems it might be useful, and work with mental health professionals on both the M.D. and PhD sides of the system. End editorial note.]
Article Source: The
Do Antidepressants Prevent Suicide in Teenagers? Answer: Maybe
A
Dr. David Shaffer, Irving Philips Professor of Child Psychiatry at
Dr. Shaffer noted that the suicide rate for youth 15-19 had steadily declined since approximately 1988 for white males, who commit the most suicides in the age group, and since 1994 for minority males. Use of drugs and alcohol in this age group either increased significantly (drinking) or remained fairly constant (drug use), according to slides presented by Dr. Shaffer. However, use of antidepressants for children 0-17 increased 10-fold since 1985, suggesting at least a statistical cause-and-effect for the suicide rate drop.
He said the conclusion was buttressed by autopsy studies showing that suicides had reduced levels of serotonin in their brain, suggesting a biological connection. SSRIs generally act to slow the brain’s absorption of serotonin, which generally assists the central nervous system in, among other things, the thought process. Dr. Shaffer noted that suicide generally is a result of diagnosable depression combined with impulse and loss of self-control. SSRIs act as a brake on such impulses and improve self-control, according to Dr. Shaffer.
Some attendees noted that the few double-bind trial experiments of SSRIs on children had been somewhat inconclusive because placebos were shown to be nearly as effective as the drugs. However, the “placebo effect” has been widely noted even in studies of physical illness to provoke an improvement in condition among many patients.
Dr. Shaffer spoke at a forum called Improving Children’s Mental Health: The Bright Futures Approach, co-sponsored by the National Institute for Health Care Management and the U.S. Department of Health and Human Services. The overall purpose of the seminar was to present methods for encouraging pediatricians and general practice physicians to diagnose mental health problems in children for referral to a specialist. In this way, speakers said, there could be greater identification of children with mental health problems and unmet needs provided for.
Source: Conference attendance, 2/5/02 [Return to Headlines Page]
Depressive Symptoms in Welfare Moms Bring
Depression to their Children
Mothers on welfare are more likely to be depressed than others, and this condition negatively influences their children, according to a study summarizing seven earlier reports on the subject. Thirty to 45 percent of welfare moms reported symptoms of depression, compared to 20 percent of moms in the general population. Children of these moms ages 5 to 7 were more likely to exhibit disobedient or bullying behavior. Children 8 to 10 displayed more depressive behaviors than the general peer population, including acting sad or showing low self-esteem. Children of depressed welfare moms who also were illiterate or had low literacy displayed the most depressive symptoms and showed them the earliest.
The report can be found at www.childtrends.org. [Return to Headlines Page]
Source: Child Trends, press release 12/27/01
Alcoholism, Depression Linked?
There may be a genetic link between alcoholism and depression, according to new research. Studies of people who suffer from the conditions indicate a genetic link in an area of the human genome called chromosome 1.
“It’s impossible to say whether it’s a single gene or multiple
genes,” said John Nurnberger of the
The research is the first to suggest a genetic connection between two disparate mental conditions. The result does not mean that scientists know how to reverse the mechanisms that predispose people to addictive drinking or depression. Nor does it mean that genes predict with certainty who will suffer from them.
“There is also a critical aspect of the environment,” said David Goldman of the National Institute on Alcohol Abuse and Alcoholism. “Nobody becomes alcoholic who doesn’t drink one alcoholic beverage at some point in their life.”
Goldman estimated there could be as many as 500 candidate genes in the areas identified – and they could work differently in different individuals, in conjunction with environmental factors.
“People are trying to scale this Mount Everest peak,” he said of the attempt to understand the biological basis for such mental and addictive disorders. “They have more or less established the base camp and the first way station up the mountain.”
Source:
The
"Prayer helps some people cope with schizophrenia and
depression" -- Fuller Theological Seminary,
Source:
The
Ritalin May Improve Academic Results of Teens with ADHD
An
eight-week study of 45 teenagers diagnosed with ADHD by the
Source: The Washington Post, 6/5/01, p. 11. [Return to Headlines Page]
DISCLAIMER: Unless otherwise indicated, all commentary and information on this web site is provided by persons who have no formal training in medicine or mental health. You should weigh the information and comment on this site in consultation with a mental health professional.
The Food and Drug Administration has ordered that a “black box” label be applied to the most commonly prescribed drugs for treating attention deficit-hyperactivity disorder (ADHD) on grounds they can cause sudden death. This follows by three months an FDA panel's 8-7 vote to recommend the labeling. The FDA usually adopts such recommendations. These drugs are used by 10 percent of 10-year-old boys in the United States and are increasingly prescribed for “adult onset ADHD”.
The panel recommendation followed reports of several dozen patients who suffered cardiac arrest, toxic reactions or sudden death while using the medications. The black box labeling -- so-called because of the black border required around the warning -- already is applied to antidepressants when prescribed for children and teens because of clinical studies suggesting some patients have thoughts of suicide after taking the drug. Only about 10 percent of all prescription drugs carry such warnings.
The labels will be applied to bottles of Ritalin, Concerta, Methylin, Metadate, Adderall and Adderall XR. In September 2005, the FDA required Eli Lilly to revise the labeling for its ADHD drug, Strattera, to include a boxed warning regarding increased risk of suicidal thinking in adolescents and children being treated with the drug. Strattera differs from other ADHD drugs because it is not stimulant-based.
The principal concern of the panel seemed to be patients with hypertension, but the recommendation would not be limited to use of ADHD with such patients.
Source: The Washington Post, 2/10/06, p. A1
Depressed Child comment: Childhood and adolescent depression frequently is misdiagnosed as ADHD. Although the FDA panel did not mention risk of suicide from administering ADHD drugs to depressed patients (other than the Strattera warning which was addressed separately), the panel’s warnings of other dangerous side effects should heighten parental concern that mental health providers are not simply taking the “easy” diagnosis of ADHD when a more thorough examination might indicate depression.
Eli Lilly & Co. has agreed to a request from the FDA to add a "black box" label to its popular drug Strattera (atomoxetine), prescribed to treat Attention Deficit/Hyperactivity Disorder warning of "uncommon reports of suicidal thoughts among children and adolescents" taking the drug. Testing disclosed the biggest danger of suicidal thinking and, in one instance among those tested, attempted suicide, to be among boys under age 12.
Strattera is a selective norepinephrine reuptake inhibitor (SNRI). It is not to be confused with selective serotonin reuptake inhibitors (SSRIs) used to treat depression, which already are subject to an even stronger "black box" label. ADHD medicines are generally contra-indicated for depression. Older ADHD medicines, such as Ritalin and Adderall, which contain amphetamine-type stimulants, with their attending "ups" and "downs", may be dangerous for depressed children, according to many authorities. Apparently Strattera, a newer ADHD drug which does not contain such stimulants, must also be weighed against risk for depressed kids.
According to Psychiatric News, a publication of the American Psychiatric Association, Lilly itself suggested the addition of the black box label when it submitted data from 12 clinical trials involving approximately 2,200 children and adolescents. However, Psychiatric News also reported that the data was not submitted until the FDA asked for it.
Of the 2,200 children and adolescents studied, 1,357 received the drug and 851 received a placebo. Five "possibly suicide-related" cases were identified in patients taking atomoxetine (0.37 percent) and no cases appeared in those taking the placebo, according to the Psychiatric News report. A sixth case was identified as a suicide attempt in a patient taking the drug. According to the Centers for Disease Control and Prevention, 17 percent of adolescents thing about suicide a year. Among high school students, 12 percent of girls and 5 percent of boys attempt suicide a year. Ultimately 2 per 100,000 girls and 12 per 100,000 boys die as a result of such attempts. This translates into approximately 2000 young people who commit suicide annually.
Overall, pediatric patients taking the drug were deemed to be about 2.5 times more likely to have a "possibly suicide-related" event, all but one of which were limited to suicidal thinking. The one exception was a suicide attempt. All of these occurred in males under age 12. There were no completed suicides in the tested population.
The New York Times quoted a Lilly spokesman as saying that the evidence of suicide risk was not strong enough for doctors to change the way they prescribe the drug. The Times said some 3.4 million children and adults have taken Strattera, the only non-stimulant drug approved for treatment of ADHD.
Sources: Psychiatric News, p. 1, 10/21/05; The New York Times, p. A19, 9/30/05.
A small Australian study supports what experts have long thought -- that there is little relationship between depression in young children and family dysfunction. Researchers looked at many factors, including marital partner change, mother's health in pregnancy, a child's health in the first six months of life and maternal anxiety in over 5,000 mothers over a period of five years. Few of these factors correlated with early childhood depression. According to the study, which was published in the journal Social Psychiatry and Psychiatric Epidemiology, it depended on reports by mothers about their children's experiences, and thus may be flawed by the lens through which the children were examined. The researchers also warned that single, low-income mothers were often lost to follow-up during the years of the study and the children of those mothers might be expected to have higher rates of depression. The New York Times quoted Dr. Jake Najman, the lead author and a professor of sociology at the University of Queensland, as saying "if what we have found out is correct, then depression in children has a large constitutional component" that is transmitted either genetically or by exposure to risks before or during pregnancy.
Source: The New York Times, p. D6, June 14, 2005
The Federal Food and Drug Administration (FDA) has "toned down" the warnings it initially intended to require on anti-depressants prescribed to children and adolescents. According to the Psychiatric News, a publication of the American Psychiatric Association, the warnings now specifically modify the originally planned warnings with reference to results of medical studies.
The FDA announced in the fall of 2004 that it would require "black box" warnings that use of most anti-depressants prescribed for children (the exception being Prozac, which is approved for use with children) risked an increase in suicidal thinking. This conclusion was based on a handful of studies in which some tested patients, all of them adolescents, reported thinking about committing suicide while on the drugs. No suicides were reported among the test patients, however, and it was widely noted that adolescent suicide rates have declined since the anti-depressants began being prescribed for teen-agers.
Apparently impressed with the need for more reserved language than was originally announced, the FDA's new warnings specifically cite to the studies. For example, according to the APA News, an original warning proposed was:
Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with Major Depressive Disorder and other psychiatric disorders.
The revised language is narrower:
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.
The Depressed Child welcomes the limiting language. It is the position of this website that scaring parents away from medication is not a useful approach to the treatment of juvenile mental health. Rather, the focus should be on obtaining qualified, focused, responsible treatment, which may or may not include medications and "talk therapy." The original warnings were not supported by the evidence and were too threatening. There are few enough tools for treating depressed children. Exaggerating the dangers of one was counter-productive.
Source: Psychiatric News, 3/4/05, p. 1
Canadian health regulators suspended use of Adderall XL, a widely
used amphetamine-based drug used to treat attention deficit
disorder/hyperactivity disorder (ADHD) in children and adolescents
on February 9, 2005 citing an unexpectedly large number of deaths by
children who used the drug as prescribed. No similar action is
expected by the Food and Drug Administration in the
United States, but the FDA required
the manufacturer to strengthen its warning label to state that
misuse could result in sudden death. Adderall is sold in the
[The Depressed Child believes that depression and bipolar disease often are misdiagnosed as ADHD. Drug treatments such as Adderall and Ritalin are contra-indicated for depression and bipolar, so the dangers from misdiagnosis are significant even without consideration of deaths from Adderall itself. All parents of children diagnosed with ADHD but who show signs of depression or bipolar disease should carefully question the healthcare giver about why ADHD was diagnosed and if drug treatment is warranted despite the dangers.]
The Therapeutic Products Directorate, Health
Canada's equivalent of the FDA, suspended sales
after a routine review of safety information they were provided by
the drug's manufacture,
Twelve cases of sudden death among children 7-16 were reported between 1999 and 2003. These were cardiac deaths. There was no mention in the news reports of the Canadian action that any youngsters had committed suicide as a result of Adderall.
Source: Psychiatric News, 3/4/05, p. 2
The Food and Drug Administration has adopted the recommendation of a panel of experts and now requires that antidepressants commonly prescribed for children carry strong warning labels that the drugs can sometimes spur suicidal behavior. Consistent with the panel's recommendation, the FDA stopped short of recommending that use of the drugs be banned for treatment of depressed kids. The FDA action comes after details of drug company testing on children of the drugs disclosed that a small percentage had a higher risk of suicide than those taking a placebo.
The panel heard from parents of depressed children who killed themselves while on antidepressants and other parents whose children seemed to improve when treated with the same drugs. The FDA seemed to heed both camps by imposing tough warnings but permitting use of the drugs children if under the supervision of qualified child psychiatrists.
The statistics on use of antidepressants with children and adolescents have provoked a raging debate over whether such drugs are useful or are worse than no drug treatment at all. The debate has largely ignored the fact that the other common treatment -- talk therapy -- has virtually no standards and little objective testing by which its effectiveness or, more importantly, the effectiveness of individual therapists, can be assessed. According to The Washington Post, the American Psychiatric Association expressed its "deep concern" that the black-box warning required by the FDA would have a "chilling effect" on treatment. The APA said "we believe the biggest threat to a depressed child's well-being is to receive no care at all." (See also story immediately below about a government study suggesting that Prozac is a useful treatment for teen depression).
The panel's recommendation would apply to all antidepressants of the family of selective serotonin reuptake inhibitors (SSRIs), which includes those most commonly used on children. They include Zoloft, Effexor and Wellbutrin. Prozac, the only antidepressant the FDA has approved for use with children, presumably also will include the warnings.
The warning would be printed in a black-bordered box on the label and state that the drugs can sometimes spur suicidal behavior in children and teenagers. The panel also recommended that the drugs be accompanied by an easy-to-read pamphlet explaining how to decide if the child is an appropriate candidate for the drug and the warning signs of suicide. The panel also suggested the FDA consider requiring that parents sign a form that they understand the risks before a child receives his or her first pill.
The FDA action falls far short of the outright ban on prescribing antidepressants for children adopted by British medical authorities (see story below). The New York Times noted that requiring the new labels means that antidepressants no longer will be shipped to pharmacies in bulk for redistribution in smaller packages. Instead, they will be shipped individually boxed, like Tylenol or Advil. The Times quoted a spokesman for the National Association of Chain Drug Stores as saying it may be difficult for some pharmacies to find room to store the inventory and that limits on package size may make it impossible for physicians to prescribe more or less pills than contained in a box.
Although 4,000 children and adolescents were tested in roughly 24 studies considered by the FDA panel, no child among the group committed suicide. Approximately 3 percent of those given antidepressants reported increased thinking about suicide and there were one or two suicide attempts. Far fewer testers on placebos reported suicidal thinking.
Contrasted to these numbers is the undisputed fact that since psychiatrists began prescribing SSRIs for children and adolescents about a decade ago, the suicide rate for that age group has dramatically declined. Since no one has been able to establish a definite link between either the overall suicide rate decline or the increased suicidal thinking in the test group, the cases for either an outright ban or enthusiastic support of drug treatment are weak. Therefore, the FDA panel's recommendation -- strong warnings and even consent letters -- seems sound.
Depressed Child Comment: We continue to believe drug treatment has a place in the treatment of some mentally ill children, including depressed children, but that it is critical that parents not rely on "casual" prescriptions from pediatricians or others not specifically trained in psychiatry -- preferably child psychiatry. A parent needs to identify a psychiatrist who is not automatically prescribing drugs, but who carefully assesses the child and is aware of the delicate balances required to assess what drug, if any, to prescribe and how much. It is then critical that the parent monitor the child closely and learn about depression, bipolar disease and how they are treated. It also is critical that drug treatment be accompanied by counseling by a qualified child psychologist who has a written treatment plan, is happy to confer with the parent, and adequately answers questions from the well-informed parent. Drugs or not, THE PARENT MUST TAKE CHARGE.]
Source: The New York Times, 10/16/04, p. A8; The Washington Post, 10/16/04, p. A1; Associated Press, 9/14/04
While skepticism about their effectiveness grows, sales of drugs to
treat mental problems of kids continues to grow. According to
an annual analysis of drug use trends by Medco Health Solutions,
Inc.,
Source: Associated Press, 5/17/04
Elliot Spitzer, the attorney general for the state of
"The point of the lawsuit is to ensure that there is complete information to doctors for making decisions in prescribing," Spitzer told The New York Times in an interview after the lawsuit against British drug company GlaxoSmithKline was announced. "The record with Paxil, we believe, is a powerful one that shows that GSK was making selective disclosures and was not giving doctors the entirety of the evidence."
GSK issued a statement in response to the lawsuit saying it "has acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies."
In a related article, The Times reported how SmithKline Beecham, which was later merged into GSK, promoted to the psychiatric profession one study of Paxil suggesting it might help depressed adolescents and provided only brief public exposure to a later study showing it provided no more benefit than a sugar pill.
Sources: The New York Times, 6/3/04, pp. A1 and C1.
The U.S. Food and Drug Administration, apparently concerned that antidepressants are too freely prescribed by physicians with little or no training in mental illness or mental health pharmacology, is requiring drug manufacturers to place detailed caveats about drug side effects and risks, including suicide, more prominently in their packaging. The FDA was expected to require stricter suicide warnings on antidepressants prescribed for children and adolescents, but the agency surprised many by expanding the requirement to all age groups.
"It warns physicians that patients' depression may become worse," said Dr. Russell Katz, the agency's chief of neurological drugs. It warns "that they may develop suicidal thinking or behavior after the initiation of treatment," Katz was quoted in The New York Times. The new rules were issued on March 22, 2004.
The FDA confessed that its evidence of increases suicide risk from patients taking antidepressants was mostly anecdotal and that recent studies sponsored by the drug companies showed no significant risk of suicide in adults from antidepressants.
The Times quoted Dr. Robert Temple, associate director of medical policy at the FDA, as saying "we think this is good advice whether the drugs did it or not. If someone commits suicide, it doesn't really matter whether it's the drugs or the underlying disease. In either case, you need to pay attention."
Others quoted by The Times suggested that the warnings were a result of some physicians prescribing antidepressants too casually, with insufficient follow up and referral to psychiatrists and psychologists. Dosage and symptoms are critical and confusing in the field of depression and can have serious negative consequences if prescribed without a full workup by an expert in the field. Antidepressants, for example, are contraindicated for bipolar disease, which shares symptoms with depression.
All antidepressants are subject to the warning requirements, including Prozac, which the FDA approved for use with children only last year. Others include Zoloft, Paxil, Wellbutrin, Luvox, Celexa, Lexapro, Effexor, Serzone, Remeron and Zyban.
The FDA's announcement seemed rather casual as to whether there was any actual connection between the antidepressants and suicide risk. There is no research disclosing a chemical link between antidepressants and suicide, and obviously those who are identified as needing an antidepressant may be more inclined to suicide than the general population. Further, suicides among adolescents have declined in the last decade as antidepressants have more commonly been prescribed for teen-agers. This is a statistical comparison, but also boasts no proven chemical connection.
See related stories and Depressed Child comment below.
Source: The New York Times, 3/23/04, p. A1 and 3/24/04, p. A13.
By The Depressed Child
Witnesses on the scene at a Holiday Inn in Bethesda, Md. heard sad and angry parents of childhood victims of suicide blame antidepressant drugs for the tragedies, and a scientific advisory panel of the U.S. Food and Drug Administration took heed and urged the FDA to issue stronger warnings to doctors about possible risks to children from drugs to treat depressed and bipolar children. The presentation on February 3, 2004, followed by little more than a week a report by a group of pharmacologists which defended use of "selective serotonin reuptake inhibitors" (SSRIs) to treat such patients.
Although the FDA does not seem likely to go so far as British health authorities and warn against use of these drugs in treating children, the advisory panel's recommendation seemed a precursor to issuance of strong warnings that prescribing such drugs should be done with great caution and promoting the fear that the drugs may in fact cause suicide -- a conclusion that is far from proven. The FDA is going to take up the issue later in the year.
"Our sense is that we would like in the interim [before the FDA completes its review] to go ahead and issue stronger warning indications to clinicians" about the chance the antidepressants might be linked to suicidal thinking and behavior, hostility or other forms of violent behavior," The New York Times quoted Dr. Matthew Rudorfer, a scientist at the National Institute of Mental Health and the chairman of the FDA advisory committee. Dr. Rudorfer was reported as saying such a warning would not discourage doctors from using the antidepressants but would alert them to warning signs that a drug might be having harmful effects.
Dr. Thomas Laughren, the team leader for the FDA's division of neurophamacological drug products, said the agency took the panel's recommendation "very seriously" and that it would probably issue such a warning "sooner rather than later," according to The Times.
Along with the experts, the advisory panel heard from parents of children who had taken their own lives after taking antidepressants. One parent's 13-year-old son hanged himself from a closet hook. A teenager told the panel he took a gun to school and threatened classmates but had no recollection of his actions. He blamed antidepressant drugs. But other parents said the drugs saved their children's lives. "I shudder to think of their plight if these medications were not available," said a woman who identified herself as the mother of a manic depressive.
There was no suggestion in any of the news reports about the
The pharmacology group, meanwhile, tried to stem what seems to
be a growing sentiment to issue stern warnings to discourage use of
drugs for depression among children. They called the
link to suicide in studies of the effectiveness of SSRIs on children
"weak." The team from the
In the summer of 2003, the FDA approved use of Prozac to treat depression in children. Although none of the other SSRIs or other antidepressant drugs are approved for such use by the FDA, it is not illegal for physicians to prescribe drugs for children which are approved for use generally by the FDA.
Separately, The Washington Post charged (almost hysterically) in its January 29, 2004 editions that the manufacturers of popular SSRIs, including Paxil, Zoloft and Effexor, have "refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal." The Post quoted a number of interested critics and doctors as claiming the drug tests probably showed that the drugs were ineffective or dangerous. The drug companies claim the data constitute trade secrets.
[The Depressed Child recommends that children diagnosed with severe depression be treated by a psychiatrist with experience with such patients and that a regimen of counseling by a child psychologist plus drug therapy (prescribed by a child psychiatrist) is the best prescription. This web site suggests (and now, it appears, the FDA agrees) that one problem with drug therapy may be that too often pediatricians or others without solid training in the administration of psychotropic drugs may be under-prescribing or over-prescribing or even mis-prescribing these drugs, leading to adverse reactions. Moreover, while the tests of such drugs on children do seem inconclusive, the fact suicide has declined with the advent of these drugs and that many patients and parents swear they have brought relief cannot be ignored. Finally, while the media and the medical profession can be counted upon to report on all major anti-drug (and "wonder drug") issues, the true underlying failure of the mental health profession is its inability to direct parents to accountable, professional and caring doctors and therapists and, in fact, the antagonism of the profession to establishing and enforcing standards of care in mental health, especially for children. See our Commentary page for more.]
Earlier stories on the battle over the efficacy and danger of antidepressants for children follow.
Sources: The New York Times, 2/3/04, p. A12; The New York Times, 1/23/04, p. A12; Reuters News Service as reprinted in The Wall Street Journal, /22/04, p. D2; The Washington Post, 1/29/04, p. A1.
Read a Depressed Child Commentary on how this news is another indication how the mental health industry has let down our children. Click here.
On December 10, 2003, British health authorities recommended that antidepressants, other than Prozac, not be used on children under 18. This was a significantly more serious warning than the same regulators announced early last summer, when they warned against use of only one antidepressant with children, Paxil. The latest warning applies to six drugs: Paxil, Zoloft, Effexor, Celexa, Lexapro and Luvox.
The reasons for the warning were identical to those cited in cautioning against use of Paxil a few months ago: Increased thoughts of suicide among patients receiving the drugs were not outweighed by proof of effectiveness in reducing depression among those 18 and younger. In other words, the health agency felt the benefits of most SSRIs for children did not outweigh the risks. Prozac was exempted from the warnings because it has been shown to be effective among youngsters in reducing depression.
A review of the tests by the Depressed Child calculates that the total universe of test subjects was 2,288, divided among five of the antidepressant drugs. No test subject committed suicide. Of the 1,187 who received a tested drug, 53 reported suicidal thoughts or made attempts at suicide (those numbers are not broken out), or 4.7%. Of 1,050 subjects who received a placebo, 25, or 2.38%, reported suicidal thoughts or made attempts at suicide. Significantly more test subjects had to drop out before the testing was completed due to adverse side effects. A total of 116 taking the test drugs dropped out (8.72%). Interestingly, 47 test subjects reported an adverse reaction to the placebo (4.81%). The statistical breakdown can be viewed by clicking here.
The agency also cautioned that it was not recommending that current treatment with the listed drugs on a children cease if the drugs seemed to have a positive effect. It warned that no one should immediately cease their drug treatment, but do so, if at all, only under the advice of their physician or psychiatrist. But the health agency recommended that no new treatments with the drugs be initiated on persons under 18. It also noted that the warning did not apply to use of Luvox and Zoloft for children suffering from obsessive-compulsive disorder, citing studies showing that the two drugs were effective in treating the disorder.
Tests among children of most of the listed drugs, which are collectively called SSRIs for selective serotonin reuptake inhibitors, demonstrate a strong placebo effect – children taking a sugar pill who are told it is an antidepressant show a positive effect nearly as often as children taking the real drug. This causes many professionals to question whether the drugs are effective. The tests, which the British agency relied upon in issuing its warnings, also disclosed some increase in suicidal thinking by children taking the drugs. The increase was more than among those children taking the placebo. The weak association of effectiveness combined with the evidence of increased suicidal thinking caused the warning to be issued.
In the U.S., several psychiatrists quoted in the media again noted that since the introduction of a variety of SSRIs over a decade ago, the incidence of suicide among adolescents has declined sharply. They called the British announcement an over-reaction. Further, it is not unexpected that a population of depressed children will express suicidal thoughts, although few follow through with suicide or suicide attempts. Finally, critics have claimed that too often pediatricians and family doctors have prescribed antidepressants for children when they are not sufficiently educated about their different effects and dosages, effectively resulting in a misuse of the drugs.
The U.S. Food and Drug Administration is pondering the issue of treating children with SSRIs. Earlier in 2003 it approved use of Prozac on children, the only SSRI specifically approved for such use. It also cautioned about use of other antidepressants on children, but the caution was a mild one. (See related news stories below). However, psychiatrists, psychologists and physicians have been prescribing other SSRIs, especially Zoloft, to children for many years without specific FDA approval. The FDA is sponsoring a meeting in February 2004 at which the issue will be analyzed and discussed, with possible regulatory action following.
Source: The New York Times, 12/11/03, p. A1
The Food and Drug Administration has issued a controversial and almost contradictory advice letter about possible dangers of antidepressants prescribed for children which ultimately seems to provide little guidance to either mental health practitioners or the parents of children diagnosed with depression.
The advice letter, issued October 27, 2003, warns that clinical studies of the effectiveness of the major antidepressant drugs on children identified some patients as having suicidal thoughts and in some instances patients attempted suicide. In the same breath, the FDA notes that such results among patients suffering depression are not unexpected.
Thomas Laughren, the FDA's team leader for psychiatric drug products, said the agency has found enough reason for concern to request additional information from the drug companies. "We're not saying these drugs can't be used" with children and adolescents Laughren told The Washington Post. "We're saying one should proceed with caution... Once we analyze the data more fully, we'll be in a better position to make a more formal recommendation."
An important but oft-noted result of the clinical trials was that nearly as many patients receiving a placebo (a sugar pill with no medicine) seemed to register as much or more improvement in their condition than the patients who received the tested medicine. This "placebo effect," which also has been observed in tests of a wide range of other drugs for both mental and physical ailments, was not, however, the reason for the FDA's letter. Instead, the FDA suggested that in at least some clinical tests suicidal thinking and attempts were greater among those on the tested medicine than on the sugar pill -- suggesting a possible increase in such thinking and suicide attempts due to the medicine itself.
The 20 placebo-controlled trials assessed by the FDA involved eight antidepressants (The Depressed Child has identified the more common brand names in parenthesis): citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox -- used more for obsessive/compulsive disorder than for depression), mirtazapine (Remeron, Sispin, Avansa, Norset, Remorgil), nefaszodone (SerZone), paroxetine (Paxil), sertraline (Zoloft) and venlafaxine (Effexor).
"In the 20 placebo-controlled trials being considered for these 8 drugs, involving over 4,100 pediatric patients, there have been no reports of completed suicides. However, FDA has not at this point been able to rule out an increased risk of suicidality for any of these drugs," the FDA letter said.
The FDA noted that it has only approved Prozac for use with children, a step it took on January 3, 2003.
The FDA said further study was needed.
Even as it released the advisory letter, Laughren, the FDA's team leader, noted that the absolute suicide rate in the broader population has been falling since the introduction of drugs such as Prozac and Zoloft. "There were not completed suicides in any of these 20 trials," Thomas Laughren told The Wall Street Journal. "The point of this advisory is that we are still unclear if there is a signal here" that the category of drug, selective serotonin reuptake inhibitors (SSRIs) causes suicide or suicidal thinking.
"I think the FDA needs to be cautious about attributing particular
adverse effects to a potentially helpful medication for the general
public," David Shaffer, chief of child and adolescent psychiatry at
The Journal said that earlier in October the Archives of General
Psychiatry evaluated
U.S. drug prescription patters and suicide rates and found that when
antidepressant use rose in various regions, the suicide rate among
youths ages 10 to 19 dropped. The researchers, from
The FDA's action followed a similar warning issued last June by medical regulators in Britain focused on Paxil. The FDA followed suit with respect to Paxil last summer. Last September, Wyeth Laboratories warned that its product, Effexor, might also increase suicide risk for children. In none of these warnings was there any indication an actual suicide occurred while on the medications. However, an article in the August 2003 issue of The Journal of the American Medical Association reported that another antidepressant, Zoloft, might ease suicidal ideation without any harmful side effects. However, the same study found a high placebo effect. As if that were not sufficiently confusing, yet another study recently warned that antidepressants of the categories addressed by the FDA are harmful for persons suffering bipolar disease, which shares some characteristics of depression. (Separate stories on all the studies referenced in this paragraph can be found below on this web page).
The Wall Street Journal also noted in its coverage that in an August 2003 editorial The Journal of the American Medical Association concluded that "current evidence continues to support the use of SSRIs, particularly fluoxetine [Prozac] and sertraline [Zoloft] in the treatment of major depressive disorder in children and adolescents."
(You can read the letter and related FDA materials at http://www.fda.gov/cder/drug/advisory/mdd.htm).
Sources: U.S. Federal Food and Drug Administration; The Washington Post, 10/28/03, p. A2; The Wall Street Journal, p, D6
As the debate rages over whether drugs such as Prozac and Zoloft are helpful to children, no better than a placebo, or cause a small number of children to think more of suicide, Eli Lilly & Co. announced it is nearer to FDA approval of yet another antidepressant, this one purportedly carrying double the action of the existing drugs. The drug, called Cymbalta, is not yet approved for adults, but Lilly says it may be available as early as next summer. There is no suggestion Lilly is also seeking approval from the FDA to administer the drug to children, but most of the antidepressants administered to children today are not FDA-approved for that purpose.
Most of the current crop of drugs work to maintain higher levels of the naturally occurring chemical serotonin in the brain, based on a theory that some people are depressed because their serotonin levels are insufficient or, more technically, that the serotonin is "taken up" by the brain's receptors before it can properly complete its job of helping transmit information among the synapses. These drugs are called selective serotonin reuptake inhibitors.
There are at least four brain chemicals that help communicate among the synapses of the brain, however. Another is norepinephrine. Lilly's new product acts on both serotonin and norepinephrine. According to The Wall Street Journal, which reported that the FDA had approved of the manufacturing facilities planned for the drug, "some prominent psychiatrists believe this dual action could give Cymbalta an important niche in treating physical pain that often accompanies depression in many patients. In any event, as many as 30% of depression patients aren't helped at all by existing medications."
Source: The Wall Street Journal, 10/31/03, p. B4
The two news articles immediately below report that manufacturers of two antidepressants -- Paxil and Effexor -- are warning that those drugs may be both ineffective in children and cause a relatively small increase in suicidal thinking. But an August article in the Journal of the American Medical Association reports on new research suggesting that a third antidepressant of the same category, Zoloft, may ease depression in some children without increasing thoughts of suicide.
As if that were not confusing enough for both medical practitioners, patients and their parents, another study released recently concludes that antidepressants in general are harmful to patients with bipolar disease ("manic depression"). That study claims that the best treatment for manic depression is an old one which has heavy-duty negative side effects and is almost never prescribed for children -- lithium.
Despite all the recent studies suggesting problems with the SSRI
(selective serotonin reuptake inhibitor) antidepressants, which have
been viewed by many as a low-side effect breakthrough which can be
prescribed for children, experts note that since SSRIs have been
available and prescribed for children, the suicide rate among
U.S. adolescents has dropped. David Shaffer, chief of Child and
Adolescent Psychiatry at
A big problem with the warnings about suicidal thoughts among depressed children taking SSRI medications is that children, especially depressed children, think about suicide even without drug treatments. it seems inconsistent to attack drugs that are intended to treat the depressed, who sometimes are suicidal, because they think about suicide after taking the drugs. But the tests indicate there is less suicidal thinking among those taking a placebo.
Dr. Joseph Biederman, a psychiatry professor at Harvard medical School and Massachusetts General Hospital, told the Journal that as many as a quarter of adolescents in the U.S. have entertained thoughts of suicide at least once. The AMA Journal study noted that half of adolescents with major depression attempt suicide at some point in their lives. Biederman was quoted as saying British regulators "have taken a severe position." "I would be very reassuring to parents who are considering the use of medications," Biederman told the Journal.
The study reported in the AMA Journal involved 376 kids from six to 17 years old examined over a 10-week period. Sixty-nine percent of those taking Zoloft saw significant improvement compared with 59 percent on a placebo. For a treatment to be deemed successful, patients had to see at least a 40 percent improvement in the symptoms of major depression. Zoloft also was more successful than the placebo in treating irritability, low self esteem, excessive weeping, listless speech and lethargic behavior. Two patients each on Zoloft and the placebo attempted suicide during the study.
The study was sponsored by Pfizer, Inc., which manufactures Zoloft.
The lithium study, sponsored by Solvay Pharmaceuticals, a maker of
the drug, and also published in the AMA Journal, compared use of
lithium to Depakote, a frequently prescribed drug to treat manic
depressives. Manic depression is less common than depression.
From 1.3 percent to 1.5 percent of people in the
U.S. suffer from bipolar disorder and their risk of committing suicide is
estimated to be 10 to 20 times that of the rest of the population,
according to an article reporting on the study in The New York
Times. The study concluded that patients taking Depakote were
2.7 times more likely to kill themselves as those taking lithium.
The study was based on medical records of 20,638 patients aged 14
and older in
The Times quoted some experts as saying that the study was unreliable because it was based on patient records rather than blind testing of active patients. Dr. John Leonard, a spokesman for Abbott Laboratories, the maker of Depakote, said conclusions should not be drawn from the data.
[Note from The Depressed Child: Our lay opinion is that SSRIs can still be effective for children. But these studies all support our view that parents must search out specialists to assess their children's mental disorders and make appropriate treatment decisions based on the diagnosis. That means, in the case of prescribing drugs, child psychiatrists, not pediatricians, neurologists or psychotherapists. But whoever makes the diagnosis, the parents should be informed, ask questions and challenge the diagnosis or treatment decision if they have doubts. If the parent doesn't pay close attention, no one will.]
Sources: The Wall Street Journal, August 27, 2003, p. D1; The New York Times (Lithium)
Wyeth Warns Effexor May Increase Suicide Risk in Kids
Wyeth Drugs has warned doctors the antidepressant Effexor may increase suicide risk in kids. The warning follows by two months a similar alert issued by health regulators in the United Kingdom concerning the antidepressant Paxil (see story below). Neither Paxil nor Effexor are approved for use with children by the federal Food and Drug Administration, but those and similar antidepressants are often prescribed for children. Only Prozac has been found safe and effective for children by the FDA among the newer class of antidepressants, called SSRIs (for "selective serotonin reuptake inhibitors).
In a letter to doctors, Wyeth said recent clinical trials of children ages six to 17 did not demonstrate efficacy in treating anxiety or severe depression. According to The Wall Street Journal article, researchers in unpublished studies saw "increased reports of hostility and, especially in Major Depressive disorder, suicide-related adverse events such as suicidal ideation and self-harm."
The Journal said some researchers believe Wyeth is acting especially cautiously because of safety questions that arose about its hormone-replacement therapy earlier in the year. Researchers who have seen the Wyeth studies on Effexor report that two percent of children taking the drug for depression reported considering suicide, compared with none in the group taking the placebo. There were no reports of an actual suicide in any of the Effexor studies.
The Wall Street Journal, Sept. 3, 2003, p. D3
Health regulators in the United Kingdom warned in early June that doctors should not prescribe the antidepressant Paxil for children, claiming that information provided by the manufacturer indicates the drug might cause some children to have suicidal thoughts and potential suicidal behavior. No suicides have been reported blamed on the drug, however, according to GlaxoSmithKline PLC, the manufacturer.
Nine trials involving more than 1,000 patients between the ages of 7 and 18 showed that certain side effects -- mood swings, increased crying, suicidal thoughts and potential suicidal behavior -- were twice as high (3.2 percent) in the Paxil group as in those taking a placebo (1.5%). The company also said the tests suggested Paxil was not much help in treating depression, either.
"It has become clear that the benefits of [Paxil] in children for
the treatment of depressive illness do not outweigh the risks,"
concluded the
Paxil is a selective serotonin reuptake inhibitor (SSRI). SSRIs are considered among the safest and most effective drugs for treating depression. Last winter, the U.S. Food and Drug Administration approved another SSRI, Prozac, for treatment of depressed children. Although that was the first FDA approval for use of SSRIs for children, psychiatrists and pediatricians have been prescribing them for children for years. Other SSRI category drugs include Zoloft, Celexa, Prozac (generic name: Fluoxetine) and Effexor.
Glaxo said no one has committed suicide due to Paxil and the drug
has been prescribed for millions of patients since 1990. "We
don't believe there's any compelling evidence that Paxil causes
suicide," a Glaxo spokesman told The Wall Street Journal. "If
anything, it reduces suicidal tendencies" in patients suffering
depression. The Journal said that complaints about Paxil had
increased in the
The Journal noted that some years ago there were many complaints that Prozac caused some depressed people to consider or attempt suicide, leading the FDA to examine the issue. The FDA found "no credible evidence" that antidepressant drugs caused suicide or violent behavior.
The Journal said the UK
recommendation has irked some
U.S. physicians who believe Paxil is effective. The Journal quoted
Douglas Robbins, director of child and adolescent psychiatry at
Depressed Child Note: We cannot help but ask -- when is someone going to examine if there is a link between suicides and amphetamine treatments for ADHD, such as Adderall and Ritalin?]
Source: The Wall Street Journal, 6/11/03, p. B1
Although some child psychiatrists and even pediatricians have been prescribing antidepressants for their patients for years, the U.S. Food and Drug Administration has issued its first approval of such treatment. On January 3, 2003, the FDA announced that it had approved use of Prozac to treat children and adolescents ages seven to 17 for depression and obsessive compulsive disorder (OCD). It is the FDA's first approval of any antidepressant for children.
The action affirms that drug treatments can be effective for
depressed children. The FDA press release noted that the National
Institute of Mental Health estimates depression affects up to 2.5
percent of children and about 8 percent of adolescents in the
"Today's approval of Prozac for use in children and adolescents was based on two placebo controlled clinical trials in depressed outpatients," the FDA said. The studies for depression produced a "statistically significant" effect of the drug compared to a placebo. A similar effect was found on children suffering OCD.
The FDA noted that, in addition to side effects of Prozac found in some adults (nausea, tiredness, nervousness, dizziness, difficulty concentrating), children 8 to 17 gained, on average, about a half inch less in height and one pound less in weight compared to patients treated with a placebo. The clinical significance of this is unknown, the FDA said.
The FDA action is likely to encourage doctors to prescribe Prozac and other antidepressants in the selective serotonin reuptake inhibitor (SSRI) for children. These other drugs include Zoloff and Wellbutrin.
The manufacturer of Prozac, Eli Lilly, does not presently plan to market Prozac for use with children, but child-specific information about use of the drug for children will be included in the FDA-mandated literature accompanying the drug.
Depressed Child Note: This is welcome news. In our lay view, all tools should be considered to relieve children of the devastation of serious depression, including drugs and counseling. This might encourage more open thinking about drug use for depression. It also may discourage a common view among psychologists (who cannot prescribe drugs) that counseling alone is sufficient treatment, although it is often long term while children are needing more immediate help, is ill-defined and is even less subject to testing for effectiveness than are drugs.
Source: FDA Press Release, http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01187.html
On November 26, 2002, the Food and Drug Administration approved use of a new drug to treat ADHD -- atomoxetine, which will be marketed under the brand name Strattera beginning in January. This is the first ADHD drug which does NOT contain a stimulant and is NOT listed as a Schedule II drug, as are amphetamine-based drugs Ritalin and Adderall. This means the FDA believes the drug will be less subject to abuse. According to a spokesman for the manufacturer, Eli Lilly, Strattera increases the level of norepinephrine, a chemical in the brain that transports signals between nerve cells. Most previous medicines have targeted another neurotransmitter called dopamine. Both are believed to play a role in ADHD. Depression and anger generally seem to be more effected by a reduction in a third neurotransmitter -- serotonin.
The Washington Post quoted E. Clarke Ross, chief executive officer of the patient advocacy group Children and Adults with ADHD, as saying that a larger range of treatments, especially with a new class of medicine, was welcomed by families dealing with the disorder. "It is still going to be important for parents to ask lots of questions and weigh all the risks and benefits of any treatment approach before they decide what's best for their child," said David Fassler, a psychiatrist at the University of Vermont College of Medicine and an authority on children's mental health problems. "Any treatment has both risks and benefits, and from the early indications, this appears to be a safe medication which is well tolerated by children. But we really want to see much more data."
Source: The Washington Post, Nov. 27, 2002, p. A2
A study which will surprise no one keeping up with the extraordinary growth in ADHD prescriptions for (mostly) boys, suggests that prescription drug use is growing faster among children than among the elderly and baby boomers. Drug spending on pediatric patients has increased by 85 percent over the last five years, according to an analysis by Medco Health solutions, a pharmacy benefits management company and a subsidiary of Merck, the pharmaceutical company.
The Medco study did not find that children take more medicine than adults. Rather, children account for just five percent of prescription drug expenditures. But more young people are taking prescription drugs today than five years ago and are taking them for longer periods, according to the study. The study's authors concluded that the increase was caused by two factors. First, certain conditions, including asthma, allergies and hyperactivity, are being diagnosed more frequently and treated more aggressively than ever before. Second, the overall costs of medicines is up.
The study examined prescription use among 500,000 children under age 19. It found that 48.9 percent of children took one or more prescription drugs within the past year, compared with 45.7 per cent five years ago. The average time a child spent on medication also increased, to 51 days in the past year from 38 days five years ago.
Source: The New York Times, 9/19/02, p. A 23
In what passes for a revolution in the field of psychotherapy,
New Mexico is the first state to permit psychologists, who receive an education in psychology up to a Ph.D. level and use talk therapy (but are not sufficiently trained in medicine to become an M.D. -- the chief distinction of a psychiatrist) to prescribe medications such as Prozac, Zoloft, Adderall and other drugs used to treat mental illnesses. A psychologist will be required to undergo 450 hours of training in psychopharmacology and medicine before he or she is able to write prescriptions for patients.
[Depressed Child Note: This is another chapter in the long battle between non-medical psychologists and the MDs, including general practitioners as well as psychiatrists, who can write prescriptions. This battle has intensified over the years as better performing drugs come on the market to treat mental illness. These drugs have fewer side effects than older drugs and have been a factor in causing insurance companies to push for briefer, drug-based treatments over "talk therapy."
[As usual in these battles of professionals, the patient is the loser because psychologists are reluctant to recommend drug treatment for fear of losing patients to psychiatrists, denying the patient an important component of treatment. On the other hand, fewer and fewer psychiatrists attempt to also conduct a "talk therapy" practice due to the high cost of their time and insurance company limits, contenting themselves with seeing patients long enough to prescribe and adjust mediations.
[Time will tell if New Mexico's experiment causes psychologists to genuinely embrace drug therapy as an important part of their overall treatment plan, of if they will use their newfound authority simply to dissuade patients from seeking additional help from a medically trained practitioner. The history of psychology includes a substantial amount of faddish treatment and use of untested approaches which does not give great comfort that the New Mexico approach will result in better patient treatment. We'll see. End Depressed Child Note].
Source: The Washington Post, 7/1/02, p. 1A.
Genes which may suggest predisposition to attention deficit/hyperactivity disorder are believed to be located in a stretch of 100 to 150 genes on chromosome 16, according to a study reported in the American Journal of Human Genetics. The finding was based on review of samples of 277 biological siblings with ADHD. The genetic region also has been implicated in autism, suggesting a link in the causes of the two mental conditions.
The Wall Street Journal quoted a lead researcher as saying that years of additional research would be necessary to identify specific genes which might cause ADHD.
Source: The Wall Street Journal, p. D-3, Oct. 22, 2002
A new study finds a lack of innovation in the prescription industry despite the industry’s constant claim that high drug prices are necessary to foster innovative research. The study, released last month by the National Institute for Health Care Management Foundation, found that two-thirds of the prescription drugs approved by the Food and Drug Administration between 1989 and 2000 were identical to existing drugs or modified versions of them.
The Foundation said that drug companies apply for FDA approval of drug formulas only slightly different those already approved and in use as a means of extending their patent monopoly. This prevents cheaper, generic drugs from reaching the market.
[A report by the St. Petersburg Times (“What makes an 8 cent pill cost $1.29”) recently disclosed that many chain drug companies markup generic drugs substantially – 300 to 3000 percent – rather than allow them to reach customers at a much cheaper price than patented drugs. The drug chains claimed that patented drugs already were so expensive that they could not tolerate a large markup, so the drug chains make up the profit by adding additional markups to generic drugs!]
The Wall Street Journal quoted a spokesman for the Pharmaceutical Research and Manufacturers of America, a lobbying organization for drug manufacturers, who called the NIHCMA report “little more than a political and financially motivated cheap shot.”
Two management consultants who presumably have large drug customers as clients also wrote an article for the Wall Street Journal editorial page attacking the report. See Developing the Personal Drug of Choice, WSJ 6/11/02.
Source: The Wall Street Journal, p. A3, 5/29/02
Researchers at the University of Maryland in Baltimore recently expressed concern that SSRI antidepressants such as Zoloft and Prozac are being prescribed for children without sufficient evidence that it is safe to do so, especially when dispensed along with drugs such as Ritalin used to treat ADHD. A research team led by Magno Zito found that as of 1994 about 3 per cent of people ages 2 to 19 used antidepressants, including SSRIs (Selective Serotonin Reuptake Inhibitors).
Zito told The Washington Post that one of the greatest concerns is where stimulants such as Ritalin or Adderall are prescribed for ADHD and the child is also taking antidepressants. "We need to know lots more about the efficacy" of those overlapping treatments, Zito told the Post.
Zito suggested that children with ADHD or depression be carefully assessed by a medical professional, who should then work to find the right medical dose. Change in behavior must be carefully monitored to track benefits or problems.
[Note from The Depressed Child: ADHD drugs are stimulants which cause "highs" and, when they wear off, as they do every day, "lows." It has long been suspected by some professionals that these stimuli are contra-indicated for children with depression, and especially those who are bipolar. There is also some evidence suggesting that stimulants prescribed to children who are depressed may contribute to suicide and attempted suicide. It is waaaaay past time for well-funded studies in this area.]
Article: The Washington Post Health Section, p. F5, May 14, 2002 [Return to Headlines Page]
Research
from
About 340
people were randomly assigned to receive either hypericum, the
active ingredient in
Zoloft, produced by drug giant Pfizer, Inc., also did not do well. Only 24.8 percent of Zoloft patients experienced a complete lifting of depression. However, researchers said Zoloft was the best at showing some improvement, if not a complete removal of depression, and noted that testers were restricted to 50 to 100 milligram doses of Zoloft, although it is often given to patients in 200 milligram doses.
"There has been a culture of belief that if it's called herbal, it must be good," Robert M. Califf, director of the Duke clinical Research institute and an investigator in the study told The Wall Street Journal. "But this study shows it is certainly not providing any benefit."
Source: AMA Journal website and The Wall Street Journal, April 10, 2002, p. D6 [Return to Headlines Page]
Adolescent depression combined with high receptivity to tobacco advertising plays a power role in whether a teen smokes cigarettes, according to researchers at the Georgetown University School of Medicine. The study, funded by the National Institute on Drug Abuse of the National Institutes of Health, measured the habits of 1,123 high school freshmen, 40 percent of whom had at least attempted to smoke. Thirty-four percent had high receptivity to tobacco advertising as shown by ability to name a heavily-advertised brand, identifying a favorite tobacco ad and reporting they were willing to use a tobacco industry product. Students "self-reported" on whether they were depressed [a potentially serious defect in the study, it seems to The Depressed Child]. The study is published in the March 2002 issue of the Journal of Pediatric Psychology.
Source: NIDA press release, March 27, 2002
Brain neurons communicate with each other by secreting messenger chemicals, such as serotonin, which cross the synaptic gulf between cells and bind to receptors on neighboring cell membranes. Medications that enhance such binding of serotonin to its receptor are widely prescribed to treat anxiety and depression, suggesting serotonin plays an important role in mental health. According to a study of mice deprived of the gene which manufactures one of several types of serotonin receptors, mice without the receptor show symptoms of anxiety. They moved around less than normal mice in open spaces, balked at entering mazes and were slower to eat. Further experiments suggested that the receptors located in the forebrain are most important. The report was funding by the National Institute of Mental Health and is published in the March 28, 2002 edition of Nature.
Source: NIMH press release, March 27, 2002
The three leading antidepressants -- Prozac, Zoloft and Paxil -- are equally effective, according to a report released December 18. The report, published in the Journal of the American Medical Association, also said that 40 percent of the 573 patients studied switched brands or stopped using them altogether, claiming they were ineffective, had unwanted side effects, or for other reasons. The study was funded by Eli Lilly & Co., which manufactures Prozac. Prozac lost its patent protection in August and its main ingredient, fluoxetine, is now available in generic brands. The study said it was the first to compare the effectiveness of the selective serotonin reuptake inhibitors (SSRIs).
Source: The Washington Post, 12/19/01, p. A12. [Return to Headlines Page]
Selective serotonin reuptake inhibitors (SSRIs) which are commonly taken to relieve depression may also reduce heart attack risk. Earlier studies have indicated that depression may have a link to heart attacks. The tested SSRIs -- known by common brand names as Prozac (fluoxetine), Luvox (fluvoxamine), Paxil (paroxetine) and Zoloft (sertaline) -- were used by 143 test participants. The heart attack rate was 65 per cent lower than the rate for a control sample not using the drugs over a 28-month period. Whether there was an actual chemical effect warding off heart attacks, or whether taking the antidepressants caused lifestyle changes that were beneficial, is not known. An abstract of the study, which appeared in the Oct. 16 edition of Circulation Magazine, is at www.circulationaha.org.
Sources: Washington Post Health Section, 10/16/01; New York Times Health Section, 10/16/01. [Return to Headlines Page]
An investigational drug named atomoxetine may relieve symptoms of ADHD without the stimulants used in methylphenidate (e.g., Ritalin), according to a manufacturer-sponsored, limited study of children and adolescents. Researchers randomly assigned 297 children and adolescents to one of three groups, whose members received increasing doses of atomoxetine, or to a fourth group, whose members received a placebo. The two higher doses of atomoxetine were more effective than the lower dose or placebo. The drug was not tested against drugs such as Ritalin which contain stimulants. An abstract of the study can be found online at www.pediatrics.org.
Source: Washington Post Health Section, 11/13/01. [Return to Headlines Page]
A study published in the British Medical Journal in late July 01 of more than 9,000 British women found that 13.5 percent of the women responding to questionnaires and followed up by regular evaluations passed "the threshold" for depression when they were 32 weeks pregnant. Eight weeks after delivery, 9.1 percent still met the threshold. Previous studies tentatively have linked depression and anxiety during pregnancy to low birth weight, premature birth and reduced blood flow in the womb.
"This will be a surprise to many because most people think that
women are protected from depression during pregnancy, that it is a
time of emotional well-being," said Dr. Ruta Nonacs, a perinatal
psychiatrist at
The study's lead investigator, Jonathan Evans, a senor lecturer in
psychiatry at
Source: Associated Press article in
The
A study of 11,064 white, well-educated, employed women participating in a breast cancer prevention trial found that Tamoxifen does not increase the risk of depression. Tamoxifen is used by many women to treat or to reduce the risk of developing breast cancer. Abstract of the study can be found at http://jnci.oupjournals.org.
Source: Washington Post Health Section, 11/13/01. [Return to Headlines Page]
An article in June's Diabetes Care suggests that depression may cause diabetes, possibly because of inactivity and overeating that often accompany depression. According to a report on the article in The New York Times, it has long been assumed that diabetes can be a cause or contributor to depression. But the reverse is only now becoming accepted as a possibility. There is a higher incidence of depression among diabetic women than of the population as a whole.
Source: The New York Times, June 12, 2001, p. D7. [Return to Headlines Page]
The new Prozac Weekly, which has been heavily advertised, may not be as effective as a daily dose of the drug to combat depression and also may have some additional unwanted side effects, such as diarrhea, nervousness and thinking problems. According to the Medical Letter on Drugs and Therapeutics, as reported in the Washington Post, clinical trials involving 501 patients showed 37 percent of patients taking the weekly form experienced a relapse of depression, against 26 percent of patients taking the daily dose and 50 percent receiving a placebo.
Patent on Prozac daily expires later this summer, likely resulting in marketing of cheaper generic forms of the drug. But Eli Lilly's patent on Prozac Weekly is good until 2004, according to the Post.
The Medical Letter said that Prozac Weekly is intended only for patients taking 20 mg of the daily Prozac. Some patients take as little as 10 mg per day and others as much as 80 mg per day.
Source: The Washington Post, June 12, 2001, Health Section, p. 7. [Return to Headlines Page]
Barr Laboratories is one of five firms approved by the FDA to sell a generic version of Eli Lilly & Co.'s Prozac antidepressant. Prozac's patent protection has expired, allowing manufacture of the genetic versions. The genetic version is expected to cost about 50 cents a tablet versus the $2.50 per tablet cost of "the real thing."
Source: Numerous newspaper articles during the first week of August 01. [Return to Headlines Page]
The negative finding stands in sharp contrast to previous research, including at least 20 studies showing that the herb did work for depression. But most of the earlier studies have been criticized for flaws like being too brief or including too few patients to yield meaningful results.
The authors of the new study say their work is the first large, scientifically rigorous trial of the herb in patients with major depression. That condition is defined as a sad or depressed mood that lasts two weeks or more, along with at least four other symptoms like feelings of guilt or worthlessness, suicidal thoughts, decreased energy and changes in appetite and sleep. The symptoms can range from mild to severe and are thought to affect 1 in 15 Americans, women more than men.
Dr. Richard c. Shelton, a professor of psychiatry at Vanderbilt University and the director of the study, described the results as “remarkably negative,” and said, “Since we know there are treatments out there that do work, I would recommend that folks choose an active treatment rather than St. John’s wort.”
Dr. Shelton said there was no convincing proof to support the use of
Dr. Shelton said a more definitive answer might come from another
study still under way, sponsored by the National Institutes of
Health, comparing
“If the NIH trial is consistent with our data,” he said, “I think that probably puts it to rest for people with major depression.”. . . . . . .
Dr. Shelton’s study was financed by the National Institute of Mental
Health and Pfizer, Inc., which manufactures antidepressants and a
[The study] was conducted at 11 teaching hospitals in the
The patients were assigned at random to receive either an extract of
After eight weeks, there was no difference between the placebo group
and those who took the herb. About 27 percent who took
In the study, a few more patients taking
Source:
The
Sad from 3-years-old but not diagnosed until 38
I am so sorry to hear about Daniel’s story. I had a
19 year old friend that also took his life this way. I can’t
believe that the doctor didn’t recognize that he was depressed. I
hope you have a lawyer. The reason I am writing is that I just
wanted to let others know that I can remember first feeling
depressed at the age of 3 believe it or not. I knew I should be
happy but I just couldn’t snap out of it. My sister who was 8 years
older was the one who noticed I wasn’t acting right. My parents
didn’t believe her. I was finally put on medication at 26 and found
to be type II bipolar at 38. I tried many medications until I got
the right mix. It was a very painful process and unless you have
been there it is hard to understand. Those were very dark times in
my life. I think it is safer to assume your child is depressed and
deal with it that way instead of the doctor assuming it is just a
phase. It is also important to find the right doctor. I have been
through too many to count but you have to keep looking for one that
listens to you because as you said, you know your child best. There
is no excuse for what happened to your family and it wasn’t your
fault!
I have a very strange life-long battle with depression. It
is especially strange because I don't have depression. I am a
(usually) happy, upbeat, optimistic person. But I have been battling
the toll it has taken (and continues to take) on my family and I
think of it as a pervasive genetic disease.
My grandfather (whom I never met) committed suicide in his
fifties. He had just lost his daughter (my mother's sister) to
cancer the day before. I guess, he must have been depressed.
Unfortunately, many others have lost children to cancer -- but few
jump out apartment windows.
My mom held her own until she was a young mother. When I was
three, she attempted suicide
and was nearly successful. She was
institutionalized for months. After that, the depression would come
and go. It got bad again, when I was 12. More than once she
attempted suicide when I was home alone with her, leaving me in my
adolescence to pick up the pieces. Again, a major bout of depression
when I was in college.
Meanwhile, my older sister battled childhood depression. She
was angry all the time, tormented my brother and me. And no one knew
how (or was capable of) getting her the help she needed.
You might say I had every environmental reason to grow up
depressed. Amazingly, I got through it all -- without even the help
of a therapist. I went on to have a happy social life and a
successful career. I just couldn't wait to put the misery behind me,
find a nice "normal" guy and have a happy, "normal" family. Eleven
years after finding the right guy, we are happily married with three
sons: a 7 year old and twin 4 year-olds. And my eldest son -- who
has every advantage in life and NO REASON at all to be unhappy -- is
suffering from childhood depression. We started seeing symptoms as
early as age four. I've learned -- when it's in the genes -- you can
run, but you can't hide. It just amazes me that my husband and I are
two such mentally stable people, and yet I still managed to pass
this on to my son. So now, as an adult, my life is still
overshadowed by this dreadful disease.
I am happy to say that my mother and sister are both doing
very well now -- with the help of the right medication, and are very
supportive with respect to my situation with my son. They know what
we're going through. And we are still trying to find the right
medication (and therapy) for my son. He is a bright boy and we
desperately want to help him. Wish us luck!
Ed. Note: We all do wish you luck and keep you in our prayers.
[Return to
Personal Stories Page]
I am the mother of 5 children, 4 boys and a girl, in
that order. I started having steady symptoms of depression after my
youngest was about 2. I realized what was going on because I am also
a RN. I also started having troubles with Obsessive/Compulsive
Disorder as well. My mother also has symptoms of depression and OCD
for many years, while I was a little girl. Both of us are on
medication now and doing well. My sister also started on medication
recently. It seems that the symptoms seem to get worse when we
become adults. I don't remember feeling abnormally depressed as a
child.
Yet, I have a 9-year-old son, Jason, who is struggling
with this. He was a delightful infant and even a fun little toddler
(no terrible two's for him). Then he turned four and we have been
struggling ever since. He has been on Zoloft for six months and that
seems to keep the depressive symptoms a little under control. We
still have lots of problems with provoking his siblings, hitting and
defiant behavior. At first, I thought this anti-social behavior was
different from the depression, but after reading this website, I
realize it is all part of the depression. He takes only 50 mg. of
Zoloft and after administering the depression test from your website
he still scored 22, which means maybe we don't have the right dose
or the right med. This has been a frustrating road for me as a nurse
as I am used to diagnosis and treatment as definite.
Another frustration for me has been our lack of
resources. We live in a very rural area. We do not have access to
pediatric psychiatrists or psychologists. Amazingly enough, Jason is
very smart and does very well in school (if he is not bored - once
bored he gets very disruptive). He does have some fine and gross
motor delays, but I am not sure if that is related to the depression
or something else. It is a mystery how to get on top all the
symptoms and help him understand how to interact with society so he
can be a productive and happy adult.
DISCLAIMER: Unless otherwise indicated, all commentary and
information on this web site is provided by persons who have no
formal training in medicine or mental health. You should weigh the
information and comment on this site in consultation with a mental
health professional.