Study Evaluating Desvenlafaxine Sustained-Release (DVS-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 Two Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
1 other identifier
interventional
480
1 country
25
Brief Summary
The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-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
Started Feb 2006
Shorter than P25 for phase_3 major-depressive-disorder
25 active sites
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
January 12, 2006
CompletedFirst Posted
Study publicly available on registry
January 16, 2006
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedDecember 28, 2007
December 1, 2007
January 12, 2006
December 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.
Secondary Outcomes (1)
Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of major depressive disorder
- Must be able to swallow tablets
- Must be at least 18 years of age.
You may not qualify if:
- Clinical diagnosis of other psychiatric disorders
- Significant risk of suicide
- Unstable medical conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Beverly Hills, California, 90210, United States
Unknown Facility
Northridge, California, 91324, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Miami, Florida, 33173, United States
Unknown Facility
St. Petersburg, Florida, 33702, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Smyrna, Georgia, 30080, United States
Unknown Facility
Libertyville, Illinois, 60048, United States
Unknown Facility
New Orleans, Louisiana, 70115, United States
Unknown Facility
Farmington Hills, Michigan, 48336, United States
Unknown Facility
Clementon, New Jersey, 08021, United States
Unknown Facility
Moorestown, New Jersey, 08057, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
New York, New York, 10024, United States
Unknown Facility
Dayton, Ohio, 45408, United States
Unknown Facility
Toledo, Ohio, 43623, United States
Unknown Facility
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, 29407, United States
Unknown Facility
Columbia, South Carolina, 29201, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Brown Deer, Wisconsin, 53223, United States
Related Publications (7)
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: 25758058DERIVEDSoares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.
PMID: 24571916DERIVEDLiebowitz MR, Manley AL, Padmanabhan SK, Ganguly R, Tummala R, Tourian KA. Efficacy, safety, and tolerability of desvenlafaxine 50 mg/day and 100 mg/day in outpatients with major depressive disorder. Curr Med Res Opin. 2008 Jul;24(7):1877-90. doi: 10.1185/03007990802161923. Epub 2008 May 27.
PMID: 18507895DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
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
January 12, 2006
First Posted
January 16, 2006
Study Start
February 1, 2006
Study Completion
January 1, 2007
Last Updated
December 28, 2007
Record last verified: 2007-12