Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission

Phase 4

Completed

• Conditions: Depression

• Registration Number: NCT00546494
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study Completion: 2005-03
• Status Verified: 2007-10
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Last Update Submitted: 2007-10-18
• Study First Posted: 2007-10-19
• Last Update Posted: 2007-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®.