Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Washington University of Michigan Rehabilitation Institute of Chicago University of Alabama at Birmingham |
---|---|
Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00592384 |
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 168 adults with SCI and major depressive disorder (MDD) who are at least one year post injury. Participants will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan and University of Alabama, Birmingham. 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.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder Spinal Cord Injuries |
Drug: venlafaxine XR Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Controlled Trial of Venlafaxine XR for Major Depression After Spinal Cord Injury: A Multi-Site Study |
Estimated Enrollment: | 168 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: placebo
identically encapsulated inactive substance
|
2: Experimental |
Drug: venlafaxine XR
Once daily oral dose ranging from 37.5 mg up to 300 mg
|
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). The prevalence of major depression in people with SCI is 22% or two to six times higher than in the general population. Depression is linked to a myriad of adverse outcomes including poor subjective health, poor community integration, higher rates of medical complications and high rates of suicide. Surprisingly there are no randomized controlled trials for treating major depressive disorder (MMD) in people with SCI. Despite the widespread use of antidepressants in this population, the common assumption that antidepressant medications are effective and well-tolerated among people with SCI is uncertain. Multiple factors such as severe stresses, bereavement and loss of rewarding activities may complicate treatment. Treatment trials suggest antidepressants may not be as effective in people with medical/neurological conditions as they are with depression that develops as a primary condition. For almost 20 years clinicians and scientists have called for controlled clinical trials of antidepressants among people with SCI in order to establish evidence-based treatment. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 168 adults with SCI and MDD who are at least one year post injury. Participants aged 18-64 will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan and University of Alabama, Birmingham. 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 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.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Charles H Bombardier, PhD | 206-744-3665 | chb@u.washington.edu |
United States, Alabama | |
University of Alabama | Recruiting |
Birmingham, Alabama, United States, 35294-0111 | |
Contact: J Scott Richards, PhD 205-934-3454 richards@uab.edu | |
Principal Investigator: J Scott Richards, PhD | |
United States, Illinois | |
Rehabilitation Institute of Chicago | Recruiting |
Chicago, Illinois, United States, 60611-2654 | |
Contact: Catherine Wilson, PsyD 312-238-1115 cwilson@ric.org | |
Principal Investigator: Catherine Wilson, PsyD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-0491 | |
Contact: Denise Tate, PhD 734-762-0971 dgtate@umich.edu | |
Principal Investigator: Denise Tate, PhD | |
United States, Washington | |
University of Washington/Harborview Medical Center | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Charles H Bombardier, PhD 206-744-3665 chb@u.washington.edu | |
Principal Investigator: Charles H Bombardier, PhD |
Principal Investigator: | Charles H. Bombardier, PhD | University of Washington School of Medicine, Department of Rehabilitation Medicine |
Principal Investigator: | Jesse R. Fann, MD, MPH | University of Washington School of Medicine, Department of Psychiatry and Behavioral Science |
Responsible Party: | Department of Rehabilitation Medicine ( Charles H. Bombardier/Principal Investigator ) |
Study ID Numbers: | 07-5325-D 01, H133A060107 |
Study First Received: | January 1, 2008 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00592384 |
Health Authority: | United States: Institutional Review Board |
spinal cord injuries major depressive disorder antidepressive agents pain |
quality of life muscle spasticity community participation anxiety |
Depression Spinal Cord Diseases Wounds and Injuries Quality of Life Disorders of Environmental Origin Central Nervous System Diseases Pain Depressive Disorder, Major Trauma, Nervous System |
Depressive Disorder Serotonin Behavioral Symptoms Spinal Cord Injuries Muscle Spasticity Mental Disorders Venlafaxine Mood Disorders |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |