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Randomised controlled trial.
Double blind (fluoxetine and placebo), single blind (cognitive behavioral therapy (CBT) and combination treatment).
Twelve weeks (treatment period only).
US; enrolment 2000–3.
439 adolescent outpatients (aged 12–17 years) with major depressive disorder (DSM-IV).
Fluoxetine, CBT (15 sessions), fluoxetine plus CBT, or placebo for 12 weeks. 10 mg/day fluoxetine or placebo, increased up to 40 mg/day by week 8 as needed.
Physical symptoms (self-reported Physical Symptoms Checklist); mania (Adolescent Depression Scale, ADS); worsening or emergence of self-reported suicidal ideation (Suicidal Ideation Questionnaire, SIQ-Jr); clinician-rated suicidal ideation; spontaneously self-reported clinically …
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