Assessment of safety and long-term outcomes of initial treatment with placebo in TADS.

ABSTRACT:

Objective

The authors examined whether initial assignment to receive placebo for 12 weeks followed by open active treatment as clinically indicated was associated with different levels of benefit and risk of harm across 36 weeks as compared with initial assignment to receive active treatments.

Method

Adolescents with major depressive disorder (N=439) were randomly assigned to receive an initial 12 weeks of treatment with fluoxetine, cognitive-behavioral therapy (CBT), combination treatment with fluoxetine and CBT, or clinical management with placebo; those assigned to placebo received open active treatment as clinically indicated after 12 weeks of placebo. Assessments were conducted every 6 weeks for 36 weeks. The primary outcome measures were response and remission based on

SUBMITTER: Kennard BD 

PROVIDER: S-EPMC2823118 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature