Project to Improve Symptoms and Mood in People With Spinal Cord Injury
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
Depression is likely the most prevalent and disabling psychological complication associated
with spinal cord injury (SCI). Yet no controlled depression treatment trials have been
performed in this population. The proposed study is a multi-site, randomized, double-blind,
placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major
depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants
will be recruited from four SCI Model System sites, the University of Washington,
Rehabilitation Institute of Chicago, University of Michigan, University of Alabama,
Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is
to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The
primary outcome will be 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 will include changes
in pain, health related quality of life depression-related disability and community
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Washington
Collaborators:
Baylor Health Care System New York University Rehabilitation Institute of Chicago Shirley Ryan AbilityLab University of Alabama at Birmingham University of Miami University of Michigan