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

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Dysthymia; Spinal Cord Injuries

Intervention: venlafaxine XR (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Charles H. Bombardier, PhD, Principal Investigator, Affiliation: University of Washington School of Medicine, Department of Rehabilitation Medicine
Jesse R. Fann, MD, MPH, Principal Investigator, Affiliation: University of Washington School of Medicine, Department of Psychiatry and Behavioral Science

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.

Clinical Details

Official title: A Controlled Trial of Venlafaxine XR for Major Depression After Spinal Cord Injury: A Multi-site Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Hamilton Depression Rating Scale-17

Hamilton Depression Rating Scale-Maier Subscale

Secondary outcome:

Symptom Checklist-20 Depression Subscale

Modified Brief Pain Inventory

Modified Ashworth Spasticity Scale

Structured Clinical Interview for DSM IV Depression Module

SF-12

Side Effects Checklist

Craig Handicap and Reporting Technique

Satisfaction With Life

Sheehan Disability Scale

Clinical Global Impression

Patient Global Impression

Hamilton Rating Scale for Anxiety

Detailed description: 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 133 adults with SCI and MDD or dysthymia who are at least one month 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, 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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Locations and Contacts

University of Alabama, Birmingham, Alabama 35294-0111, United States

University of Miami, Miami, Florida 33124, United States

Rehabilitation Institute of Chicago, Chicago, Illinois 60611-2654, United States

University of Michigan, Ann Arbor, Michigan 48109-0491, United States

Baylor Institute for Rehabilitation, Dallas, Texas 75246, United States

University of Washington/Harborview Medical Center, Seattle, Washington 98104, United States

Additional Information

Starting date: July 2007
Last updated: December 31, 2014

Page last updated: August 23, 2015

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