Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder
1 other identifier
interventional
381
1 country
37
Brief Summary
Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 depression
Started Sep 2006
37 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
August 25, 2006
CompletedFirst Posted
Study publicly available on registry
August 29, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
May 7, 2012
CompletedMay 7, 2012
April 1, 2012
1.2 years
August 25, 2006
November 26, 2008
April 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
Baseline to 8 weeks
Secondary Outcomes (12)
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
8 weeks
Percentage of Patients Achieving Remission
8 weeks
Percentage of Patients Achieving Response to Treatment
8 weeks
Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8
Baseline to 8 weeks
Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
Baseline to 8 weeks
- +7 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
Eligibility Criteria
You may qualify if:
- Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.
- 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.
You may not qualify if:
- Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Birmingham, Alabama, 35226, United States
Unknown Facility
Little Rock, Arkansas, 72223, United States
Unknown Facility
Springdale, Arkansas, 72762, United States
Unknown Facility
Palo Alto, California, 94305, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
New London, Connecticut, 06320, United States
Unknown Facility
Bradenton, Florida, 34208, United States
Unknown Facility
Miami, Florida, 33133, United States
Unknown Facility
Tampa, Florida, 33613, United States
Unknown Facility
Winter Park, Florida, 32789, United States
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Atlanta, Georgia, 30308, United States
Unknown Facility
Sandy Springs, Georgia, 30328, United States
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Savannah, Georgia, 31406, United States
Unknown Facility
Smyrna, Georgia, 30080, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
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Chicago, Illinois, 60634, United States
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Indianapolis, Indiana, 46202, United States
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Terre Haute, Indiana, 47802, United States
Unknown Facility
Shreveport, Louisiana, 71101, United States
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Rockville, Maryland, 20852, United States
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Omaha, Nebraska, 68131, United States
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Cherry Hill, New Jersey, 08002, United States
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Brooklyn, New York, 11235, United States
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Minot, North Dakota, 58701, United States
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Beachwood, Ohio, 44122, United States
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Dayton, Ohio, 45408, United States
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Toledo, Ohio, 43623, United States
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Oklahoma City, Oklahoma, 73118, United States
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Tulsa, Oklahoma, 74135, United States
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Philadelphia, Pennsylvania, 19131, United States
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Hilton Head Island, South Carolina, 29926, United States
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Austin, Texas, 78756, United States
Unknown Facility
Houston, Texas, 77007, United States
Unknown Facility
Richmond, Virginia, 23229, United States
Unknown Facility
Richmond, Virginia, 23230, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
Brown Deer, Wisconsin, 53223, United States
Related Publications (2)
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.
PMID: 25860107DERIVEDKornstein 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.
PMID: 20797382DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2006
First Posted
August 29, 2006
Study Start
September 1, 2006
Primary Completion
November 1, 2007
Study Completion
July 1, 2008
Last Updated
May 7, 2012
Results First Posted
May 7, 2012
Record last verified: 2012-04