Conditions: Major Depressive Disorder
Keywords: venlafaxine ER Major depressive disorder Japan placebo-controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 538
Healthy volunteers: no

Brief summary:
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The follow-up visit will be evaluated after 2 weeks of last study medication dosing.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: venlafaxine ER 75 mg/day (fixed dose) intervention 2: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) intervention 3: Placebo
Intervention descriptions: intervention 1: Treatment phase: 8 weeks (37.5 mg/day for 1st week and 75 mg/day for 7 weeks), oral administration Tapering phase: 2 weeks (37.5 mg/day for the 1st week and placebo for the 2nd week), oral administration intervention 2: Treatment phase: 8 weeks (37.5 mg/day for the 1st week, 75 mg/day for the 2nd weeks, 75-150 mg for the 3rd week, 75-225 mg/day for the rest of 5 weeks), oral administration Tapering phase: 2 weeks (75/37.5 mg/day for the 1st week and 37.5 mg/day/placebo for the 2nd week), oral administration intervention 3: Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration

Protocol document: