updated 8/17/2004 7:00:33 PM ET 2004-08-17T23:00:33

Combining drugs with talk therapy works best in treating depressed adolescents, the first large study of its kind has found, echoing research in adults showing that treating the disease requires more than a pop-a-pill quick fix.

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Although the study found that psychotherapy plus Prozac works better than either method alone at treating depression in adolescents, including reducing suicidal thoughts, the study does not resolve ongoing questions about potential links between some antidepressants and suicidal thoughts and behavior in children.

That’s because patients on Prozac had more suicidal tendencies during the 12-week study than any other group: those on Prozac plus psychotherapy, those on psychotherapy alone, and those on dummy pills alone.

There were no suicides and few suicide attempts during the study.

Study co-author John Curry of Duke University said too few patients exhibited suicidal tendencies — 24 out of 439 — to determine whether there truly are differences among the treatments studied.

“The first thing that needs to be clear is that the overall rates are low,” and that combining Prozac with talk therapy seems to mitigate any suicidal risks, Curry said.

Overall, 71 percent of patients on the combined treatment had scores showing substantial improvement on a depression rating scale. The combined treatment involved Prozac plus a form of psychotherapy called cognitive behavioral therapy, which teaches problem-solving skills and ways to refocus negative thoughts and behaviors.

By contrast, significant improvement was seen in 61 percent of Prozac-only adolescents, 43 percent of behavior therapy-only patients and 35 percent of patients on dummy pills.

The study is the first phase of ongoing research led by Dr. John March, Duke’s chief of child and adolescent psychiatry. The results appear in Wednesday’s Journal of the American Medical Association.

The study makes “a very important contribution” by showing that there is effective treatment, said Dr. Thomas Insel, director of the National Institute of Mental Health, which funded the study.

“I wouldn’t in any way downplay the adverse events,” Insel said. But “just because a few kids develop this doesn’t mean that you don’t treat anybody.”

Suicide questions remain
The U.S. Food and Drug Administration is investigating the suicide concerns and earlier this year asked makers of 10 drugs including Prozac to add or strengthen suicide-related warnings on their labels.

While March’s study was publicly funded, he and several co-authors have received grants and served on speakers’ bureaus for anti-depressant manufacturers. Prozac maker Eli Lilly and Co. provided the drug and dummy pills but had no role in the study design or data analysis.

The study involved 439 depressed patients aged 12 to 17 assigned to one of four treatments for 12 weeks. During that time, suicidal tendencies were seen in nine Prozac patients, six in the Prozac plus behavior therapy group, five in the behavior therapy-only group and four on dummy pills.

The study excluded adolescents at high risk for suicide based on recent suicidal behavior or pervasive suicidal thoughts.

That’s a noteworthy omission since “those are a lot of the kids who we see,” said Dr. David Fassler, a Burlington, Vt., psychiatrist who treats adolescents.

Also, the study doesn’t address whether the combined approach worked because of the specific kind of talk therapy involved, or whether other forms of psychotherapy would work as well or better, Fassler said.

Still, he said the study should be “reassuring for physicians and parents.”

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