Conditions: Major Depressive Disorder
Keywords: Unipolar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 412
Healthy volunteers: no

Brief summary:
The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).

Detailed description:
This two-arm, multicentre, randomized, placebo-controlled, double-blind, parallel-design study consisted of a baseline phase (screening and wash-out) and a double-blind randomized phase (randomization to Trazodone Contramid® OAD or placebo). The total study duration including wash-out of prohibited medications was approximately 11 weeks; the total duration of the randomized phase was 8 weeks (titration: 2 weeks + treatment: 6 weeks).

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Trazodone Hydrochloride (HCl) Extended-Release Tablets intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: