Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00300378
First received: March 7, 2006
Last updated: December 3, 2007
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depressive Disorder, Major |
Drug: desvenlafaxine 50 mg Drug: desvenlafaxine 100 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation
Secondary Outcome Measures:
- The Global Clinical Improvement will be the key secondary efficacy variable.
| Estimated Enrollment: | 480 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A primary diagnosis of MDD
- Depressive symptoms for at least 30 days before the screening visit.
Exclusion Criteria:
- Treatment with DVS SR at any time in the past.
- Known hypersensitivity to venlafaxine
- Significant risk of suicide based on clinical judgment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300378
Show 43 Study Locations
Show 43 Study LocationsSponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For Estonia, Latvia, Lithuania, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Romania, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Poland, WPWZMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Finland, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Croatia, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For South Africa, ZAFinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00300378 History of Changes |
| Other Study ID Numbers: | 3151A1-333 |
| Study First Received: | March 7, 2006 |
| Last Updated: | December 3, 2007 |
| Health Authority: | Croatia: Ministry of Health and Social Care Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Poland: Ministry of Health Romania: State Institute for Drug Control Slovakia: State Institute for Drug Control South Africa: Medicines Control Council |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Depression Adult Outpatients |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms O-desmethylvenlafaxine Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013