This project is a multisite, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 168 adults with spinal cord injury (SCI) and major depressive disorder (MDD) who are 18-65 years old and at least one month post injury. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome is the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes include changes in pain, health related quality of life, and participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.
Project Type
collaborative
Project Lead Center
Project Start Date
01/01/2005
Project End Date
12/31/2013
Participating Centers
Target Population(s)
People with SCI at least one month post injury who have depression