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Q What are the effects of fluoxetine plus cognitive behavioural therapy compared with either component alone or placebo in adolescents with depression?
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 significant adverse events including suicide-related events.
81.8% completed their assigned treatment.
Fluoxetine plus CBT, fluoxetine alone, and placebo significantly reduced physical symptom severity …
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