Antidepressants in Children

What Does the Research Tell Us?

A child's response to antidepressants cannot be predicted with certainty. One major clinical trial has indicated that a combination of antidepressants and psychotherapy is the most effective treatment for adolescents with depression. The clinical trial of 439 adolescents ages 12 to 17 with depression compared four treatment groups -- one that received a combination of fluoxetine and psychotherapy, one that received fluoxetine only, one that received psychotherapy only, and one that received a placebo only.
After the first 12 weeks:
  • 71 percent responded to the combination treatment of fluoxetine and psychotherapy
  • 61 percent responded to the fluoxetine-only treatment
  • 43 percent responded to the psychotherapy-only treatment
  • 35 percent responded to the placebo treatment.
At the beginning of the study, 29 percent of the participants were having clinically significant suicidal thoughts. Although the rate of suicidal thinking decreased among all the treatment groups, those in the fluoxetine/psychotherapy combination treatment group showed the greatest reduction in suicidal thinking.
Limited depression research has been conducted on treatment of depression in pre-pubertal children. Controlled clinical trials supporting the effectiveness of fluoxetine exist, but more research is needed to develop and test effective depression medications and psychosocial treatments for these children.

Do Antidepressants Cause Suicide in Children?

It is extremely difficult to determine whether antidepressants increase the risk of completed suicide, especially because depression itself increases the risk of suicide and because completed suicides, especially in among children and adolescents, are rare. Most controlled trials are too small to detect for rare events such as suicide (thousands of participants are needed). In addition, controlled trials typically exclude patients considered at high risk of suicide.
Recently, however, there has been some concern that the use of antidepressants in children and adolescents may cause suicidal behavior. Following a thorough and comprehensive review of all the available published and unpublished controlled clinical trials of antidepressants in children and adolescents, the FDA issued a public warning in October 2004 about an increased risk of suicidal thoughts or behavior (suicidality) in children and adolescents treated with SSRI antidepressant medications.
In the FDA review, no completed suicides occurred among nearly 2,200 children treated with SSRI medications. However, about 4 percent of those taking SSRI medications experienced suicidal thinking or behavior, including actual suicide attempts -- which was twice the rate of those taking placebo, or sugar pills.
In response, the FDA adopted a "black box" label warning indicating that antidepressants may increase the risk of suicidal thinking and behavior in some children and adolescents with depression. A black-box warning is the most serious type of warning in prescription drug labeling.
The warning also emphasizes that children and adolescents who begin treatment with SSRI medications should be closely monitored for:
  • Worsening depression
  • Emergence of suicidal thinking or behavior
  • Unusual changes in behavior (sleeplessness, agitation, and withdrawal from normal social situations).
This monitoring is especially important during the first four weeks of treatment.
SSRI or SNRI medications usually have few side effects in children and adolescents, but for unknown reasons, they may trigger agitation and abnormal behavior in certain individuals.
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