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Am J Psychiatry 2008; 165:459-467
(published online February 15, 2008; doi: 10.1176/appi.ajp.2007.07091453)
© 2008 American Psychiatric Association
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Fluoxetine Versus Placebo in Preventing Relapse of Major Depression in Children and Adolescents

Graham J. Emslie, M.D., Beth D. Kennard, Psy.D., Taryn L. Mayes, M.S., Jeanne Nightingale-Teresi, R.N., Thomas Carmody, Ph.D., Carroll W. Hughes, Ph.D., A. John Rush, M.D., Rongrong Tao, M.D., Ph.D., and Jeanne W. Rintelmann, B.A.

OBJECTIVE: The authors compared fluoxetine and placebo in continuation treatment to prevent relapse of major depressive disorder in children and adolescents. METHOD: After a detailed evaluation, children and adolescents 7–18 years of age with major depressive disorder were treated openly with fluoxetine. Those who had an adequate response after 12 weeks, as indicated by a Clinical Global Impression improvement score of 1 or 2 and a decrease of at least 50% in Children’s Depression Rating Scale—Revised score, were randomly assigned to receive fluoxetine or placebo for an additional 6 months. The primary outcome measures were relapse and time to relapse. Relapse was defined as either a score of 40 or higher on the Children’s Depression Rating Scale with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. Additional analyses were conducted with relapse defined only as a score of 40 or higher on the Children’s Depression Rating Scale. RESULTS: Of 168 participants enrolled in acute fluoxetine treatment, 102 were randomly assigned to continuation treatment with fluoxetine (N=50) or placebo (N=52). Of these, 21 participants (42.0%) in the fluoxetine group relapsed, compared with 36 (69.2%) in the placebo group, a significant difference. Similarly, under the stricter definition of relapse, fewer participants in the fluoxetine group relapsed (N=11; 22.0%) than in the placebo group (N=25; 48.1%). Time to relapse was significantly shorter in the placebo group. CONCLUSIONS: Continuation treatment with fluoxetine was superior to placebo in preventing relapse and in increasing time to relapse in children and adolescents with major depression.


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