METHODS

Design:

2 x 2 factorial randomised placebo controlled trial.

Allocation:

{concealed*}†.

Blinding:

blinded (patients and healthcare providers [fluoxetine v placebo comparison] and outcome assessors).*

Follow up period:

12 weeks.

Setting:

outpatient clinic in the US.

Patients:

439 adolescents (mean age 14.6 y, 54% girls) who had a DSM-IV diagnosis of major depressive disorder, could attend an outpatient clinic, scored ⩾45 on the Children’s Depression Rating Scale–Revised (CDRS–R), had a full scale IQ ⩾80, and were not taking antidepressants. Exclusion criteria included bipolar disorder, severe conduct disorder, substance abuse/dependence, 2 failed selective serotonin reuptake inhibitor trials (SSRI), and poor response to CBT.

Intervention:

(1) fluoxetine, from 10 mg/day to a maximum of 40 mg/day …