Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
NCT ID: NCT00369343
Last Updated: 2012-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
381 participants
INTERVENTIONAL
2006-09-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
B
Placebo
Placebo, daily (QD), tablet form, treatment period up to 8 weeks
Interventions
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Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
Placebo
Placebo, daily (QD), tablet form, treatment period up to 8 weeks
Eligibility Criteria
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Inclusion Criteria
* A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI).
* Montgomery-Asberg Depression Rating Scale (MADRS) total score \> or = 22 at the screening and baseline visit.
Exclusion Criteria
* Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* A history or active presence of clinically important medical disease.
Additional criteria apply.
40 Years
70 Years
FEMALE
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Springdale, Arkansas, United States
Palo Alto, California, United States
San Diego, California, United States
New London, Connecticut, United States
Bradenton, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Sandy Springs, Georgia, United States
Savannah, Georgia, United States
Smyrna, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Terre Haute, Indiana, United States
Shreveport, Louisiana, United States
Rockville, Maryland, United States
Omaha, Nebraska, United States
Cherry Hill, New Jersey, United States
Brooklyn, New York, United States
Minot, North Dakota, United States
Beachwood, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Hilton Head Island, South Carolina, United States
Austin, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Brown Deer, Wisconsin, United States
Countries
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References
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Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900.
Kornstein SG, Jiang Q, Reddy S, Musgnung JJ, Guico-Pabia CJ. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010 Aug;71(8):1088-96. doi: 10.4088/JCP.10m06018blu.
Other Identifiers
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3151A1-403
Identifier Type: -
Identifier Source: org_study_id
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