Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
NCT00406640
ABOUT THIS STUDY
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- 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.
- 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.
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Descriptive Information | |||||||||||||
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Brief Title ICMJE | Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women | ||||||||||||
Official Title ICMJE | A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder | ||||||||||||
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 escitalopram in women with major depressive disorder (MDD) who are postmenopausal. | ||||||||||||
Detailed Description | Not Provided | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Soares CN, Thase ME, Clayton A, Guico-Pabia CJ, Focht K, Jiang Q, Kornstein SG, Ninan PT, Kane CP. Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. CNS Drugs. 2011 Mar;25(3):227-38. doi: 10.2165/11586460-000000000-00000. | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE | 595 | ||||||||||||
Original Enrollment ICMJE | 500 | ||||||||||||
Actual Study Completion Date ICMJE | October 2008 | ||||||||||||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Additional criteria apply. | ||||||||||||
Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 70 Years (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Argentina, Chile, Colombia, Mexico, Peru, United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00406640 | ||||||||||||
Other Study ID Numbers ICMJE | 3151A1-402 | ||||||||||||
Has Data Monitoring Committee | Not Provided | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||||||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||||||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||
Verification Date | May 2010 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |