NCT00546923

Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients

A Randomized, Double-Blind, Placebo-Controlled, Pilot Study To Evaluate The Efficacy And Safety Of Venlafaxine Extended-Release In Depressed And Anxious Patients With Multiple, Unexplained Somatic Symptoms

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (planned)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To examine the efficacy and safety of venlafaxine XR in the treatment of physical and emotional symptoms in patients with an operationally-defined diagnosis of multisomatoform disorder (MSD).

Detailed description

The purpose of this study is to examine the efficacy and safety of venlafaxine XR in the treatment of physical and emotional symptoms in patients with an operationally-defined diagnosis of MSD. Primary efficacy will be evaluated using the PHQ-15 scale, and secondary efficacy will be evaluated using the HAM-D17, HAM-A, CGI, MQOL-PS, VAS and SF-36 evaluation scales. Assessment scales and questionnaires will be administered at specified clinical visits between screening and Week 12 (or discontinuation).

Conditions

• Anxiety Disorders
• Depression

Interventions

Type	Name	Description
DRUG	Venlafaxine XR

Timeline

• Start date: 2004-08-01
• Completion: 2006-06-01
• First posted: 2007-10-19
• Last updated: 2007-10-19