CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 538 enrolled
Drug / intervention
venlafaxine ER 75 mg/day (fixed dose) +2 moredrug
Likely dose
venlafaxine ER 75 mg/day (fixed dose)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01441440
NCT01441440Phase 3Completed
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A Randomized, Double-blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 27, 2011·Updated Jan 28, 2021

In Brief

A Phase 3 clinical trial evaluating venlafaxine ER 75 mg/day (fixed dose), venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), and 1 other intervention for Major Depressive Disorder. Completed, enrolled 538 participants across 63 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2011
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.8 years ago

Interventions

venlafaxine ER 75 mg/day (fixed dose)drug

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

venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)drug

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

Placebodrug

Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration