Status:
COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Depression
Depressive Disorder
Eligibility:
FEMALE
40-70 years
Phase:
PHASE3
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 pro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT00369343
Start Date
September 1 2006
End Date
July 1 2008
Last Update
May 7 2012
Active Locations (37)
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1
Birmingham, Alabama, United States, 35226
2
Little Rock, Arkansas, United States, 72223
3
Springdale, Arkansas, United States, 72762
4
Palo Alto, California, United States, 94305