Wednesday, June 2, 2004

Antidepressant Therapy, Alone or with “Talk Therapy,” Effective in Teenagers
By Pat French

Even as headlines reflect the controversy about the use of antidepressant drugs in children, a large DCRI trial has shown that one such drug, fluoxetine (Prozac), is an effective therapy for depressed adolescents, although a combination of fluoxetine and traditional psychotherapy did even better.

Investigators yesterday presented the impressive results of the Treatment for Adolescents with Depression Study (TADS) at the 44th annual meeting of the New Clinical Drug Evaluation Unit, a meeting sponsored by the National Institute of Mental Health (NIMH). This meeting focuses on psychiatric drugs, other interventions, and services related to mental health.

John S. March, MD

The DCRI’s Dr. John March presented the findings from TADS, which enrolled 432 patients at 9 sites in the U.S. between April 2000 and June 2003. The patients, who were 12 to 17 years old, all had moderate to severe depression. They were randomly assigned to receive 36 weeks of talk therapy (discussion of problems between the patient and a therapist), fluoxetine therapy, fluoxetine plus talk therapy, or placebo. They were followed for 1 year total, but the study’s design also called for a check of symptoms and functioning at 12 weeks, to correspond with the typical initial course of treatment for depression.

At 12 weeks, patients who were receiving fluoxetine plus talk therapy had the best results—71% of them “responded well.” In contrast, 61% of those taking the antidepressant alone, 43% of those receiving talk therapy alone, and 35% of those receiving placebo had this outcome. According to a different psychological measurement scale, the response rates between these last two groups were not significantly different.

The TADS findings also are relevant to current concerns about suicide among children taking antidepressant drugs. Regardless of the treatment they received, all TADS patients became significantly less suicidal. There were suicide attempts, however, and 5 of the 6 occurred in patients taking fluoxetine. According to March, “The take-home message is that these adverse events are extremely rare.”

Concern about adolescent suicide has led British regulators to ban all antidepressants except fluoxetine for children. It is the only drug approved in the U.S. for use in depression in children aged 7 to 17.

Dr. March, in addition to being a psychiatrist with the DCRI, is the director of child and adolescent psychiatry at Duke University Medical Center. TADS was coordinated by the DCRI, and the data were managed by the Research Triangle Institute. Financial support for the study was provided by NIMH.

The complete results of TADS will be published in the Journal of the American Medical Association in the fall.