Status:
COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in 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). This study will investigate the safety, efficacy, and tolerability of DVS SR versus esc...
Eligibility Criteria
Inclusion
- 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 MINI 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 :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
595 Patients enrolled
Trial Details
Trial ID
NCT00406640
Start Date
December 1 2006
End Date
October 1 2008
Last Update
December 28 2023
Active Locations (70)
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1
Peoria, Arizona, United States, 85381
2
Pasadena, California, United States, 91107
3
San Diego, California, United States, 92103
4
San Diego, California, United States, 92108