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Q What are the effects of fluoxetine plus cognitive behavioural therapy on depression and suicide ideation compared with either component alone or placebo?
Randomised controlled trial.
Double blind (fluoxetine and placebo), single blind (cognitive behavioural therapy (CBT) and combination treatment).
Twelve weeks (treatment period only).
US; enrolment 2000–3.
439 adolescents (12–17 years) with major depressive disorder (DSM-IV) and a Children’s Depression Rating Scale-Revised (CDRS-R) total score ⩾45, demonstrating impairment due to depression in at least two settings (home, school or with friends) for at least 6 weeks. Exclusions: comorbid conditions requiring medication, previously failed CBT or two trials of selective serotonin reuptake inhibitor, currently receiving psychotherapy or psychotropic medication.
Fluoxetine, CBT (15 sessions), fluoxetine plus CBT, or placebo for 12 weeks. Fluoxetine and placebo started at 10 mg/day, increased up to 40 mg/day by week 8 as needed.
CDRS-R and Reynolds Adolescent Depression Scale; achievement of CDRS-R score <28; Clinical Global Impression-Improvement …
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