NCT01441440

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

Completed Phase 3 Results posted Last updated 26 January 2021

What this trial tests

Phase 3 trial testing venlafaxine ER 75 mg/day (fixed dose) in Major Depressive Disorder in 538 participants. Completed in 1 March 2014.

Timeline

1 November 2011

Primary endpoint
1 March 2014

1 March 2014

Quick facts

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	538
Start date	1 November 2011
Primary completion	1 March 2014
Estimated completion	1 March 2014
Sites	63 locations across Japan

Drugs / interventions tested

• venlafaxine ER 75 mg/day (fixed dose) — full drug profile →
• venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) — full drug profile →
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →

Who can join

20 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination
  Time frame: Baseline, Week 8 or Early termination
  HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges fro

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan.
   Higuchi T, Kamijima K, Nakagome K, Itamura R, et al · · 2016 · cited 10× · PMID 26513202 · DOI 10.1097/yic.0000000000000105
2. Clustering patients by depression symptoms to predict venlafaxine ER antidepressant efficacy: Individual patient data analysis.
   Kato M, Asami Y, Wajsbrot DB, Wang X, et al · · 2020 · cited 5× · PMID 32912597 · DOI 10.1016/j.jpsychires.2020.06.011
3. Factors impacting the efficacy of venlafaxine extended release 75-225 mg/day in patients with major depressive disorder: exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study in Japan.
   Watanabe Y, Asami Y, Hirano Y, Kuribayashi K, et al · · 2018 · cited 4× · PMID 29844674 · DOI 10.2147/ndt.s146428