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Researchers in several studies have found that fluoxetine is significantly better than placebo for the acute treatment of major depressive disorder (MDD) in children and adolescents. Whether maintenance fluoxetine protects against relapse is an unanswered question. In this two-phase study, researchers gave fluoxetine to 169 children with MDD (age range, 7–18 years; mean age, 11.2) for 12 weeks. The 102 responders were randomized at week 12 to fluoxetine (mean dosage, 26.2 mg/day) or placebo for 6 months.
During either phase, participants who had not taken at least 70% of the pills at two consecutive visits, or at three visits overall, were discontinued from the study. Adverse events were assessed through general questions, rather than throug…