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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00406640 |
Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are postmenopausal.
Condition | Intervention | Phase |
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Depression Depressive Disorder Depressive Disorder, Major |
Drug: Desvenlafaxine succinate sustained-release (DVS SR) Drug: Escitalopram |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder |
Estimated Enrollment: | 500 |
Study Start Date: | December 2006 |
Study Completion Date: | October 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: Desvenlafaxine succinate sustained-release (DVS SR)
flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.
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B: Active Comparator |
Drug: Escitalopram
Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.
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Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional criteria apply.
Study Director: | Medical Monitor | Wyeth |
Principal Investigator: | Trial Manager | For Argentina: Scheima@wyeth.com |
Principal Investigator: | Trial Manager | For Chile: scheima@wyeth.com |
Principal Investigator: | Trial Manager | For Mexico: gomezzlj@wyeth.com |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3151A1-402 |
Study First Received: | November 29, 2006 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00406640 |
Health Authority: | United States: Food and Drug Administration |
MDD Major Depressive Disorder Depression |
Depression O-desmethylvenlafaxine Mental Disorders Mood Disorders Depressive Disorder, Major |
Dexetimide Depressive Disorder Citalopram Serotonin Behavioral Symptoms |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |