Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Three Fixed Doses (100 Mg, 200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
1 other identifier
interventional
480
0 countries
N/A
Brief Summary
To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 major-depressive-disorder
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2003
CompletedFirst Posted
Study publicly available on registry
November 13, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedAugust 19, 2009
August 1, 2009
November 10, 2003
August 18, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Outpatients
- Sexually active women participating in the study must use a medically acceptable form of contraception
- Subjects must have a primary diagnosis of major depressive disorder
You may not qualify if:
- Treatment with DVS-233 SR at any time in the past
- Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
- Known hypersensitivity to venlafaxine (IR or ER)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.
PMID: 34183490DERIVEDSoares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.
PMID: 29140227DERIVEDMcIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
PMID: 26709542DERIVEDMcIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.
PMID: 26644956DERIVEDThase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
PMID: 25758058DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 10, 2003
First Posted
November 13, 2003
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
August 19, 2009
Record last verified: 2009-08