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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00824291 |
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.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder, Major |
Drug: desvenlafaxine succinate sustained release Genetic: Genotyping |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study To EVvaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release |
Estimated Enrollment: | 400 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator | Drug: desvenlafaxine succinate sustained release |
2: Experimental | Genetic: Genotyping |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3151A1-4415 |
Study First Received: | January 14, 2009 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00824291 History of Changes |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada; United States: Food and Drug Administration; United States: Institutional Review Board |
Neurotransmitter Agents Depression O-desmethylvenlafaxine Mental Disorders Psychotropic Drugs |
Mood Disorders Depressive Disorder, Major Depressive Disorder Antidepressive Agents Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder |
Pharmacologic Actions Behavioral Symptoms Pathologic Processes Mental Disorders O-desmethylvenlafaxine Therapeutic Uses Mood Disorders Central Nervous System Agents Antidepressive Agents |