Project to Improve Symptoms and Mood in People With Spinal Cord Injury (PRISMS)
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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 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.
| 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 |
- Hamilton Depression Rating Scale-17 [ Time Frame: 0 weeks, 12 weeks ] [ Designated as safety issue: No ]The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.
- Hamilton Depression Rating Scale-Maier Subscale [ Time Frame: 0 weeks, 12 weeks ] [ Designated as safety issue: No ]The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.
- 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: placebo
identically encapsulated placebo pills 37.5 - 300 mg/day for 12 weeks
|
Drug: placebo
Once daily oral dose of placebo ranging from 37.5 mg up to 300 mg
Other Name: identically encapsulated inactive substance
|
|
Experimental: venlafaxine XR
venlafaxine XR 37.5 - 300 mg/day for 12 weeks
|
Drug: venlafaxine XR
Once daily oral dose of venlafaxine XR 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 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| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00592384
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35294-0111 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33124 | |
| 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 | |
| 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; |
| Study First Received: | January 1, 2008 |
| Results First Received: | June 11, 2014 |
| Last Updated: | December 31, 2014 |
| 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 Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Central Nervous System Diseases Mental Disorders Mood Disorders Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries Venlafaxine |
Antidepressive Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Uptake Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015