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Combined fluoxetine plus cognitive behavioural therapy is more effective than monotherapy or placebo for adolescents with depression

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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?

METHODS

Embedded ImageDesign:

Randomised controlled trial.

Embedded ImageAllocation:

Unclear.

Embedded ImageBlinding:

Double blind (fluoxetine and placebo), single blind (cognitive behavioural therapy (CBT) and combination treatment).

Embedded ImageFollow-up period:

Twelve weeks (treatment period only).

Embedded ImageSetting:

US; enrolment 2000–3.

Embedded ImagePatients:

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.

Embedded ImageIntervention:

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.

Embedded ImageOutcomes:

CDRS-R and Reynolds Adolescent Depression Scale; achievement of CDRS-R score <28; Clinical Global Impression-Improvement …

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