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Cognitive behavioural therapy plus fluoxetine offers some safety advantages over fluoxetine alone in adolescents with depression

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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?

METHODS

Embedded ImageDesign:

Randomised controlled trial.

Embedded ImageAllocation:

Unclear.

Embedded ImageBlinding:

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

Embedded ImageFollow-up period:

Twelve weeks (treatment period only).

Embedded ImageSetting:

US; enrolment 2000–3.

Embedded ImagePatients:

439 adolescent outpatients (aged 12–17 years) with major depressive disorder (DSM-IV).

Embedded ImageIntervention:

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.

Embedded ImageOutcomes:

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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