Lead Center:Northwest Regional Spinal Cord Injury System
Principal Investigator Name:Charles Bombardier, PhD
Principal Investigator Email:firstname.lastname@example.org
Target Population(s):People with SCI at least one month post injury who have depression
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.