NCT01441440

Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)

A Randomized, Double-blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 538 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	venlafaxine ER 75 mg/day (fixed dose)	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
DRUG	venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)	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
DRUG	Placebo	Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-09-27
• Last updated: 2021-01-28
• Results posted: 2015-03-13

Locations

63 sites across 1 country: Japan