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National Institutes of Health

Press Release
August 17, 2004

Combination Treatment Most Effective in Adolescents with Depression

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 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.

More information on TADS.


The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit the NIH website.