Journal of the American Academy of Child & Adolescent Psychiatry
ARTICLESFluoxetine for Acute Treatment of Depression in Children and Adolescents: A Placebo-Controlled, Randomized Clinical Trial
Section snippets
Study Design
A multiphase study was designed to examine efficacy and tolerability of various dosing strategies for fluoxetine treatment of depressed children and adolescents. The initial phase, reported here, was designed to confirm a previous report that fluoxetine 20 mg was effective and well tolerated for acute treatment of pediatric MDD.
To obtain the most reliable assessment of patients’ condition, this study incorporated an extensive diagnostic evaluation period requiring three independent diagnostic
Baseline Patient Comparisons
After 2 weeks of evaluation, and a 1-week placebo lead-in period, 109 patients were randomly assigned to fluoxetine treatment and 110 to placebo treatment (Fig. 1). There were no statistically significant differences between treatment groups in patient demographics at baseline (Table 2). Randomization of patients resulted in treatment groups that were reasonably balanced for the current comorbid conditions attention-deficit/hyperactivity disorder (ADHD), oppositional defiant disorder, and
DISCUSSION
Fluoxetine was well tolerated and effective in a double-blind, placebo-controlled study evaluating 9 weeks of acute therapy with fluoxetine 20 mg daily in 219 child and adolescent outpatients with MDD. Fluoxetine 20 mg daily was more effective than placebo for the treatment of depression as demonstrated by significantly greater improvement in the CDRS-R score. During the first week of treatment, fluoxetine-treated patients received 10 mg of fluoxetine daily. Since fluoxetine was statistically
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This study was funded by Eli Lilly and Company. Drs. Emslie and Wagner were paid consultants for Eli Lilly and Company for this study. Drs. Heiligenstein, Hoog, Brown, Jacobson, Mr. Ernest and Ms. Nilsson are employees of Eli Lilly and Company and may own stock in that company.
The authors gratefully acknowledge the contributions of the Fluoxetine Treatment of Pediatric Depression Group: Dr. Ralph S. Albertini, Butler Hospital; Dr. Mark Bangs, Riley Children and Adolescent Psychiatry Clinic; Dr. Joan Busner, St. Louis University School of Medicine, Department of Psychiatry; Dr. Jeffrey Danzinger, ICSL Clinical Studies; Dr. Robert Findling, University Hospitals of Cleveland, Department of Psychiatry; Dr. Nora Galil, NeuroScience, Inc.; Dr. Thomas Gualtieri, North Carolina Neuropsychiatry; Dr. Stuart Kaplan, St. Louis University School of Medicine, Department of Psychiatry; Dr. Markus Kruesi, Institute for Juvenile Research, University of Illinois at Chicago; Dr. Samuel Kuperman, University of Iowa Hospitals and Clinics, Department of Psychiatry; Dr. Brian McConville, University of Cincinnati; Dr. James McCracken, UCLA, Neuropsychiatric University and Hospital; Dr. Daryl Nucum, Irvine Clinical Research Center; Dr. Julia Oldroyd, Irvine Clinical Research Center; Dr. Elizabeth Reeve, Regions Hospital, Child and Adolescent Psychiatry Clinic; Dr. Robert Reichler, PsychCare Northwest; Dr. David Rosenberg, University Health Center; Dr. John Sargent, The Menninger Clinic Center of Clinical Research, Topeka, KS; Dr. Phillipe Weintraub, University of Colorado Health Science Center.