Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder
NCT00300378
Last updated date
ABOUT THIS STUDY
The primary objective is to compare the antidepressant efficacy, safety, and tolerability of
DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives
include testing both general and functional quality-of-life outcomes and satisfaction with
therapy reported by the subject.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depressive Disorder, Major
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- A primary diagnosis of MDD
- Depressive symptoms for at least 30 days before the screening visit.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Treatment with DVS SR at any time in the past.
- Known hypersensitivity to venlafaxine
- Significant risk of suicide based on clinical judgment
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Advanced Information
| Descriptive Information | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder | |||||||||||||||||||||||||||
| Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder | |||||||||||||||||||||||||||
| Brief Summary | The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject. | |||||||||||||||||||||||||||
| 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 | Depressive Disorder, Major | |||||||||||||||||||||||||||
| Intervention ICMJE |
| |||||||||||||||||||||||||||
| Study Arms ICMJE | Not Provided | |||||||||||||||||||||||||||
| Publications * |
| |||||||||||||||||||||||||||
* 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 | |||||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 480 | |||||||||||||||||||||||||||
| Original Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | January 2007 | |||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||||||||||||||
| 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 | Croatia, Estonia, Finland, France, Latvia, Lithuania, Poland, Romania, Slovakia, South Africa | |||||||||||||||||||||||||||
| Removed Location Countries | ||||||||||||||||||||||||||||
| Administrative Information | ||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00300378 | |||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 3151A1-333 | |||||||||||||||||||||||||||
| 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 | December 2007 | |||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||||||||||||||