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

This study has been completed.
Sponsor:
Collaborators:
University of Michigan
Rehabilitation Institute of Chicago
University of Alabama at Birmingham
Baylor Health Care System
University of Miami
New York University
Information provided by (Responsible Party):
Charles Bombardier, University of Washington
ClinicalTrials.gov Identifier:
NCT00592384
First received: January 1, 2008
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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) 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.


Condition Intervention Phase
Major Depressive Disorder
Dysthymia
Spinal Cord Injuries
Drug: venlafaxine XR
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Venlafaxine XR for Major Depression After Spinal Cord Injury: A Multi-site Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: weeks 0, 1, 3, 6, 8, 10, 12, 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom Checklist-20 Depression subscale [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12, 24 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
  • Modified Ashworth Spasticity Scale [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ] [ Designated as safety issue: Yes ]
  • Structured Clinical Interview for DSM IV Depression Module [ Time Frame: Weeks 0, 12, 24 ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: Weeks 0, 12, 24 ] [ Designated as safety issue: No ]
  • Side Effects Checklist [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ] [ Designated as safety issue: Yes ]
  • Craig Handicap and Reporting Technique [ Time Frame: Weeks 0, 12 ] [ Designated as safety issue: No ]
  • Satisfaction with Life [ Time Frame: Weeks 0, 12 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: Weeks 0, 12 ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ] [ Designated as safety issue: Yes ]
  • Patient Global Impression [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ] [ Designated as safety issue: Yes ]
  • Hamilton Rating Scale for Anxiety [ Time Frame: Weeks 0, 12 ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: July 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
identically encapsulated inactive substance
Experimental: 2 Drug: venlafaxine XR
Once daily oral dose ranging from 37.5 mg up to 300 mg
Other Name: Effexor XR

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 168 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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592384

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294-0111
United States, Florida
University of Miami
Miami, Florida, United States
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611-2654
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0491
United States, Texas
Baylor Institute for Rehabilitation
Dallas, Texas, United States, 75246
United States, Washington
University of Washington/Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
University of Michigan
Rehabilitation Institute of Chicago
University of Alabama at Birmingham
Baylor Health Care System
University of Miami
New York University
Investigators
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
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles Bombardier, Primary Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00592384     History of Changes
Other Study ID Numbers: 31665-D, H133A060107;, 07-5325-D 01
Study First Received: January 1, 2008
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
spinal cord injuries
major depressive disorder
dysthymia
antidepressant agents
pain
quality of life
muscle spasticity
community participation
anxiety

Additional relevant MeSH terms:
Spinal Cord Injuries
Depressive Disorder
Depression
Dysthymic Disorder
Depressive Disorder, Major
Wounds and Injuries
Mood Disorders
Mental Disorders
Behavioral Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014