Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
NCT00824291
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- Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
- Employed for 20 hours or more for a minimum of 1 month prior to baseline.
- Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.
- Treatment with desvenlafaxine succinate sustained release at any time in the past
and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
- Treatment-resistant defined as any of the following failed treatments in the past 3
years: 3 or more previous adequate trials of >=2 classes of antidepressant medication,
electroconvulsive therapy, or psychotherapy (2 adequate trials).
- Current (within 12 months prior to the screening visit) psychoactive substance abuse
or dependence (including alcohol), manic episode, posttraumatic stress disorder,
obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic
disorder.
- Clinically important abnormalities on physical examination, electrocardiogram (ECG),
or laboratory evaluations.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder | |||
Official Title ICMJE | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release | |||
Brief Summary | This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Depressive Disorder, Major | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | 437 | |||
Original Estimated Enrollment ICMJE | 400 | |||
Actual Study Completion Date ICMJE | November 2009 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years to 74 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 | Not Provided | |||
Removed Location Countries | Canada, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00824291 | |||
Other Study ID Numbers ICMJE | 3151A1-4415 B2061006 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc | |||
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 | March 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |