Study Evaluating Venlafaxine ER in Recurrent Depression

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046020
• Other study ID #: 0600B-100469
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2002
• Last updated: August 13, 2009
• Start date: August 2000
• Est. completion date: October 2005

Study information

• Verified date: August 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1096
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Recurrence

Intervention

Drug:
• Venlafaxine ER

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer