Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder
NCT00063206
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- Subjects must have a primary diagnosis of major depressive disorder (MDD)
- Depressive symptoms for at least 30 days prior to the screening visit
- Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D17)
- Treatment with DVS-233 SR at any time in the past
- Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90
days of study day 1
- Known hypersensitivity to venlafaxine (IR or ER)
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder | |||
Official Title ICMJE | A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder | |||
Brief Summary | Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo. Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D<sub>17</sub>] < 7) versus those subjects receiving placebo. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Major Depressive Disorder | |||
Intervention ICMJE | Drug: DVS-233 SR | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Liebowitz MR, Yeung PP, Entsuah R. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in adult outpatients with major depressive disorder. J Clin Psychiatry. 2007 Nov;68(11):1663-72. | |||
* 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 | 247 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | May 2004 | |||
Actual Primary Completion Date | May 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 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 | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00063206 | |||
Other Study ID Numbers ICMJE | 3151A1-304 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
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 | August 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |