Fluoxetine plus cognitive behavioural therapy was most effective for adolescents with major depressive disorder
Q In adolescents with major depressive disorder (MDD), how do fluoxetine, cognitive behavioural therapy (CBT), and their combination compare for effectiveness?
METHODS
Design:
randomised controlled trial (RCT).
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 15 y, 54% girls) who had a DSM-IV diagnosis of MDD, 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 (SSRI) trials, and poor response to CBT.
Intervention:
fluoxetine, from 10 mg/day to a maximum of 40 mg/day by week 8 (n = 109); CBT (n = 111); CBT plus fluoxetine (n = 107); or placebo (n = 112). CBT consisted of 15 sessions (50–60 min each) for …
