Project to Improve Symptoms and Mood in People With Spinal Cord Injury

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.

Conditions

• Major Depressive Disorder
• Dysthymia
• Spinal Cord Injuries

Interventions

DRUG

venlafaxine XR

Once daily oral dose of venlafaxine XR ranging from 37.5 mg up to 300 mg

DRUG

placebo

Once daily oral dose of placebo ranging from 37.5 mg up to 300 mg

Sponsors & Collaborators

• University of Michigan

  collaborator OTHER

• Shirley Ryan AbilityLab

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Baylor Health Care System

  collaborator OTHER

• University of Miami

  collaborator OTHER

• New York University

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Charles H. Bombardier, PhD · University of Washington School of Medicine, Department of Rehabilitation Medicine

• Jesse R. Fann, MD, MPH · University of Washington School of Medicine, Department of Psychiatry and Behavioral Science

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2012-09-30

Completion

2012-09-30

Countries

• United States

Study Locations