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