More threads by David Baxter PhD

David Baxter PhD

Late Founder
Antidepressant Medications for Children
Apr 28 2004
National Institute of Mental Health

Information for Parents and Caregivers from NIMH
Depression is a serious disease that causes significant problems at home, in school, and with peers. It increases a child's vulnerability to substance abuse, and puts them at risk for suicidal behaviors. Previous research has shown that depression in children and adolescents is a treatable condition. Psychological therapies, such as cognitive-behavioral therapy and interpersonal therapy, have been shown to be helpful for adolescents with depression. Medications, particularly the serotonin reuptake-blocking medications (SSRIs), have been shown to be of benefit in adults. Recently, however, concerns have been raised that antidepressant medications themselves may induce suicidal behavior and be ineffective in treating depression in youths. The National Institute of Mental Health (NIMH) offers the following information to help families and caregivers make treatment choices based on the best currently available information.

What Do We Know About Antidepressant Medications?
SSRIs (serotonin reuptake inhibitors) are considered an improvement over older antidepressants because they are better tolerated and are safer if taken in an overdose (which is an issue for patients at risk for suicide). They have been extensively tested in adult populations and have been proven to be safe and effective for adults. Note: Fluoxetine, sertraline, and fluvoxamine are approved by the FDA for the treatment of Obsessive-Compulsive Disorder because studies have shown they are safe and effective for adolescents with this disorder.

Use of SSRIs has risen dramatically in the past several years in children and adolescents age 10-19. Some research points out that this increase has coincided with a significant decrease in suicide rates in this age group, but it is not known if SSRIs are directly responsible for this improvement.

Fluoxetine has also been shown to be safe and helpful in treating depression in children 8 years and older in two different studies—one supported by NIMH and the other supported by Eli Lilly, the manufacturer of the drug. The studies found that it reduced depression for many children better than a placebo (a fake pill) and it did not increase suicide or suicidal thinking. However, fluoxetine failed to improve depression in at least one third of patients. Also, about one in 10 children experienced adverse side effects such as agitation and mania. The other SSRIs, such as sertraline, citalopram, paroxetine, and venlafaxine, have not been approved for treatment of depression in children or adolescents, though they have often been prescribed to children by physicians in "off-label use"—a use other than the approved use.

Some forms of psychotherapy, such as cognitive-behavioral therapy, have proven useful for adolescents with depression.

What Remains Unknown
Currently, there is no way of telling who may be sensitive to an SSRI's positive or adverse effects. Results thus far are based on populations—some individuals may show marked improvement, some may see no change, and some may be vulnerable to adverse effects. The response to medication of an individual patient cannot be predicted with certainty from the kind of studies that have been done so far.

It is extremely difficult to prove whether SSRIs increase the risk of suicide especially since suicide is already a significant risk in those who are depressed. In fact, no suicide has been reported among the more than 4,100 subjects enrolled in pediatric clinical trials of SSRIs. Controlled trials typically exclude patients considered at high risk for suicide, such as those with a history of suicide attempts.

The FDA is now re-analyzing existing data to try to determine if SSRIs raise the risk of suicide in children. It held a public advisory meeting in February to discuss the issue and in March requested that a warning of a possible association between use of SSRIs and suicidal behavior be inserted in the labeling of these medications.

What Should You Do for a Child With Depression?
Major depression in children and adolescents is a serious condition that should be adequately treated, which includes careful follow-up and monitoring.

Psychotherapy is the first choice for treatment of depression in children and adolescents, according to guidelines published by the American Academy of Child and Adolescent Psychiatry. Many times, psychotherapy accompanied by an early follow-up appointment may help to establish the persistence of depression before a decision is made to try antidepressant medications. Psychotherapy alternatives include "cognitive-behavioral therapy" and "interpersonal therapy."

Information for Parents and Caregivers from NIMH
Each child should be carefully and thoroughly evaluated by a physician to determine if medication is appropriate. Those who are prescribed an SSRI should receive ongoing medical monitoring, with particular care paid in the first few weeks of taking the drug.

Should nervousness, agitation, irritability, mood instability, or sleeplessness emerge or worsen during treatment with SSRIs, parents should obtain a prompt evaluation by a clinician with expertise in these medications.

Children already on any of the SSRIs should remain on the drug if it has been helpful but they should also be carefully monitored by a physician for evidence of side effects. Once started, treatment with these medications should not be abruptly stopped, because the body can react with further agitation and restlessness. Families should not discontinue treatment without consulting with their physician. All potentially effective treatments can be associated with side effects. A careful weighing of risks and benefits, with appropriate follow-up to help reduce risks, is the best that can be currently recommended.

What NIMH Is Doing
NIMH is conducting research to help clarify the potential value and risks of antidepressants, and to explore how medications compare with psychotherapy in adolescent depression. In particular, an NIMH-funded, multi-site controlled clinical trial, the Treatment for Adolescents with Depression Study (TADS), was launched in the late 1990s to directly compare the efficacy of fluoxetine, cognitive-behavioral therapy, and a combination of the two. Results are expected later in 2004.

Other studies are in progress to test the efficacy and safety of both medications and psychotherapy for youths with treatment-resistant depression and youths at increased risk for suicide attempts.

For more information on this topic, see: Antidepressant Medications in Children. Vitiello, B, Swedo, S. National Institute of Mental Health, Bethesda, MD. New England Journal of Medicine Apr 8;350(15):1489-91. See also

The SSRIs (serotonin reuptake inhibitors) include:
o fluoxetine (Prozac)
o sertraline (Zoloft)
o paroxetine (Paxil)
o citalopram (Celexa)
o escitalopram (Lexapro)
o fluvoxamine (Luvox)
o venlafaxine (Effexor)—another antidepressant closely related to the SSRIs

David Baxter PhD

Late Founder
Children still get drugs for depression

Children still get drugs for depression
May 24, 2004
Philadelphia Inquirer

The recent controversy over antidepressant use in children is not making psychiatrists prescribe the drugs less often, several area child and adolescent psychiatrists said.

But they are sometimes making different choices about which drug to use and are being especially careful to document discussions about side effects and effectiveness with parents.

"You can't help but give it more thought when it's in the newspaper and on TV all the time," said Richard Malone, a child psychatrist at the Drexel University College of Medicine.

After hearings on the contentious issue, the Food and Drug Administration in March issued a warning that patients of all ages taking antidepressants should be monitored closely for signs of worsening depression or suicide. The FDA said it is not clear whether the class of drugs known as SSRIs (selective-serotonin reuptake inhibitors) cause some depressed patients to commit suicide. It is continuing to evaluate the drugs and is expected to present more information this summer.

British regulators have said that only one of the drugs - Prozac - is appropriate for use in children. It is the only drug approved by the FDA for use in depressed children and adolescents in the United States as well, but many doctors routinely use similar drugs such as Celexa, Paxil, Zoloft and Effexor.

Publicity about the FDA hearings was followed by more news. Several scientific studies questioned whether the drugs worked in children or increased suicidal thoughts and behavior.

The notoriety has left psychiatrists, who say the drugs are much alike chemically, confused. They want more research on how well the drugs work in youngsters, plus the release of all completed studies - both published and unpublished.

Since 1990, the percentage of children diagnosed with depression and those taking medication for it has soared. A study presented this month at the annual American Psychiatric Association meeting by David Sclar, director of the Pharmacoeconomics and Pharmacoepidemiology Research Unit at Washington State University, found that doctors prescribed antidepressants in 13 of every 1,000 office visits by children and adolescents from 1990 through 1993. The rate rose to 42.6 per 1,000 visits from 1998 through 2001.

Prozac, the first of the SSRIs, was approved by the FDA in 1988. Older drugs were thought to have too many side effects in children.

Unlike in adult medicine, where primary care doctors write 70 percent of antidepressant prescriptions, Sclar said 80 percent of the prescriptions for children come from child and adolescent psychiatrists. That increases the likelihood of close monitoring, he said.

Sclar said he has seen data on prescriptions written since the FDA hearings in February and there has been no change in volume.

A study released this week by Medco Health Solutions Inc., a pharmacy benefit manager, found an increase in the proportion of children on antidepressants during the first quarter of this year. Among children taking prescription drugs of any kind, the percentage on antidepressants rose from 3.6 in the first quarter of 2003 to 4.15 this year.

Area psychiatrists said more parents are expressing concerns about the drugs, though they rarely ask to stop using them. Mark Reuben, a Reading pediatrician who is past president of Pennsylvania chapter of the American Academy of Pediatrics, said many parents of depressed children are comfortable with the drugs because they take them themselves.

Lynn Plewes, a Warminster woman who leads a support group for parents of children with mental illnesses, said she is happy with the antidepressants her two children take. She worries that bad publicity about the drugs will hurt children. "I'm afraid that a lot of families aren't going to get help for their kids," she said.

Psychiatrists said the drugs, plus therapy, are the best treatment for severely depressed children.

"We have reason to believe that these medications, if properly monitored, are very helpful to children," said Ellen Sholevar, a child and adolescent psychiatrist at Temple University.

Not all psychiatrists are sold on Prozac, because it remains in the body longer than other SSRIs. They prefer other drugs that have proven effective in adults.

Malone, though, said the controversy has made him more restrictive. "Personally," he said, "I have started to use the ones that have labeling in children, until this controversy is straightened out."

Gail Edelsohn, director of child and adolescent psychiatry at Thomas Jefferson University Hospital, said prescribing patterns at Jefferson haven't changed, but she and the other doctors are being extra careful to document their discussions with patient families.

While some pediatricians say they always refer patients they think need antidepressants to specialists, Reuben said the shortage of child and adolescent psychiatrists sometimes gives him no choice.

"It's months to get in, and they will have an issue that's acute enough that you really need to get them going," he said.

Reuben said he now schedules more frequent follow-up visits to monitor patients on antidepressants.
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