Conditions: Major Depressive Disorder
Keywords: major depressive disorder MDD depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 340
Healthy volunteers: no

Brief summary:
This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).

Detailed description:

Arms:
arm 1: None arm 2: Active control for assay sensitivity arm 3: None

Interventions: intervention 1: desvenlafaxine succinate sustained release intervention 2: fluoxetine intervention 3: placebo
Intervention descriptions: intervention 1: Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets. intervention 2: Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules intervention 3: Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules

Protocol document: