Study Evaluating DVS-233 SR in Adult Outpatients With Major Depressive Disorder
NCT00092911
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Outpatients
- Men and women age 18 years of age and older
- Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception
- 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)
- Significant risk of suicide based on clinical judgment, including common
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating DVS-233 SR 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 | The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: DVS-233 SR | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* 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 | 244 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | May 2005 | |||
Actual Primary Completion Date | May 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (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 | NCT00092911 | |||
Other Study ID Numbers ICMJE | 3151A1-320 | |||
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 |
| |||
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 |