Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious Patients
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- The primary endpoint is the change from baseline to Week 12 in the PHQ-15 total score.
- Efficacy will be evaluated by changes in the total scores of the HAM-D17, HAM-A, CGI, MQOL-PS, VAS and SF-36. Safety will be monitored by collecting spontaneously reported adverse events; vital signs and laboratory measures according to the Schedule.
|Study Start Date:||August 2004|
|Study Completion Date:||June 2006|
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).