A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder.

ABSTRACT:

Objective

The purpose of this study was to evaluate the efficacy and safety of duloxetine fixed dose in the treatment of children (7-11 years) and adolescents (12-17 years) with major depressive disorder (MDD).

Methods

Patients (n=463) in this 36 week study (10 week acute and 26 week extension treatment) received duloxetine 60 mg QD (n=108), duloxetine 30 mg QD (n=116), fluoxetine 20 mg QD (n=117, active control), or placebo (n=122). Measures included: Children's Depression Rating Scale-Revised (CDRS-R), treatment-emergent adverse events (TEAEs), and Columbia-Suicide Severity Rating Scale (C-SSRS).

Results

Neither active drug (duloxetine or fluoxetine) separated significantly (p<0.05) from placebo on mean change from baseline to end-point (10 weeks) on the CDRS-R tota

SUBMITTER: Emslie GJ 

PROVIDER: S-EPMC4026396 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature