A clinical trial of 439 adolescents with major depression has found a combination of medication and psychotherapy to be the most effective treatment. Funded by the NIH’s National Institute of Mental Health (NIMH), the study compared cognitive-behavioral therapy (CBT) with fluoxetine, currently the only antidepressant approved by the U.S. Food and Drug Administration for use in children and adolescents. John March, M.D., Duke University, and colleagues, report on findings of the multi-site trial in the August 18, 2004, Journal of the American Medical Association (JAMA).

The results of the first 12 weeks of the Treatment for Adolescents with Depression Study (TADS), conducted at 13 sites nationwide, show that 71 percent responded to the combination of fluoxetine and CBT. The other three treatment groups, of participants between the ages of 12 and 17, also showed improvement, with a 60.6 percent response to fluoxetine-only treatment, and 43.2 percent response from those receiving only CBT. The response rate was 34.8 percent for a group that received a placebo. The difference in response rates for the latter two treatment groups was not statistically significant.

The $17 million study is the first large, federally funded study using an antidepressant medication to treat adolescents suffering with moderate to severe depression. TADS was conducted between the spring of the year 2000 and the summer of 2003.

Clinically significant suicidal thinking, which was present in 29 percent of the volunteers at the beginning of the study, improved significantly in all four treatment groups, with those receiving medication and therapy showing the greatest reduction.

For more information on TADS, visit www.nimh.nih.gov/healthinformation/tads.cfm.