Study Evaluating Venlafaxine ER in Recurrent Depression

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

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