Overview

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

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
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
Treatments:
Venlafaxine Hydrochloride
Criteria
Inclusion Criteria:

- Spinal cord injury (ASIA A-D)

- At least one month post injury

- Meets DSM IV criteria for major depression or dysthymia on the SCID

- At least moderately severe depression (PHQ-9 score >= 10)

- Within reasonable travel distance to one of the study sites

Exclusion Criteria:

- Current DSM IV alcohol or drug dependence

- History of bipolar disorder or psychosis

- History of >= 2 suicide attempts or suicide attempt with 5 years

- Current suicidal intent or plan

- Medical contraindications

- Non-English speaker

- Clinically significant cognitive/language impairment

- History of allergic reaction to venlafaxine XR or use of MAO-I with 2 weeks

- Current use of antidepressant medications (will not exclude if on low dose of a
tricyclic antidepressant or trazodone for pain, sleep, or bladder), psychotherapy for
depression, or electroconvulsive therapy

- Pregnant or lactating women or women of childbearing potential who are not willing to
use a reliable form of contraception

- Unstable medical condition, as determined by physical examination, CBC w/ platelets
(including hematocrit, hemoglobin, WBC, differential), serum chemistry panel (serum
sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose), liver
transaminases (AST, ALT), thyroid stimulating hormone (TSH), urinalysis, supine
diastolic blood pressure (SDBP) > 90 mm Hg, or near terminal illness (primary care
physician estimates that patient has < 1 year to live)

- Anticipated major surgical procedures within the 12 weeks of randomization

- Use of an investigational drug within 30 days

- Use of psychoactive medications, including corticosteroids and anticonvulsants, that
have not been at a stable dose for at least 2 weeks

- Use of anxiolytic, sedative-hypnotic, or other psychotropic drug or substance
(including St. John's Wort) within 7 days of start of double-blind treatment. If the
patient is taking a sedative deemed necessary for sleep induction or spasticity, the
dosage must have been stable for at least 2 weeks. Use of anticholinergic, low-dose
tricyclic antidepressant, GABAergic or adrenergic medications for spasticity are
permitted if at a stable dose for at least 2 weeks.

- Refusal to participate