The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major...
Date First Received: September 18, 2002
Last Updated: August 13, 2009
Verified by: Wyeth, August 2009
Clinical Trial Phase: Phase 4 | Start Date: August 2000
Overall Status: Completed
Estimated Enrollment: 1096
Brief Summary
Official Title: “An Acute and Continuation Phase Study of the Comparative Efficacy Study of Venlafaxine ER (Effexor® XR) and Fluoxetine (Prozac®) in Achieving and Sustaining Remission (Wellness) in Patients With Recurrent Unipolar Major Depression; Followed by a Long Term Randomized, Placebo-Controlled Maintenance Treatment Study in Patients Treated Initially With Venlafaxine ER”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major depression
Study Type: Interventional
Study Design: Treatment
Study Primary Completion Date: October 2005
Intervention(s) in this Clinical Trial
- Drug: Venlafaxine ER
Criteria for Participation in this Clinical Trial
Inclusion Criteria
- Clinical diagnosis for recurrent major depression
Exclusion Criteria
- The patient has failed on an adequate trial of fluoxetine, venlafaxine or venlafaxine
- ER during the current episode of major depression or the patient is treatment-resistant
- Known hypersensitivity to venlafaxine or fluoxetine
- History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease, including history of seizure disorder
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor, MD Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00046020
Study ID Number: 0600B-100469
ClinicalTrials.gov Identifier: NCT00046020
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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