Project to Improve Symptoms and Mood in People With Spinal Cord Injury (PRISMS)
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ClinicalTrials.gov Identifier: NCT00592384 |
Recruitment Status
:
Completed
First Posted
: January 14, 2008
Results First Posted
: January 1, 2015
Last Update Posted
: January 1, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder Dysthymia Spinal Cord Injuries | Drug: venlafaxine XR Drug: placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 133 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
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
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- Hamilton Depression Rating Scale-17 [ Time Frame: 0 weeks, 12 weeks ]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 ]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 ]
- Modified Brief Pain Inventory [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ]
- Modified Ashworth Spasticity Scale [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ]
- Structured Clinical Interview for DSM IV Depression Module [ Time Frame: Weeks 0, 12, 24 ]
- SF-12 [ Time Frame: Weeks 0, 12, 24 ]
- Side Effects Checklist [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ]
- Craig Handicap and Reporting Technique [ Time Frame: Weeks 0, 12 ]
- Satisfaction With Life [ Time Frame: Weeks 0, 12 ]
- Sheehan Disability Scale [ Time Frame: Weeks 0, 12 ]
- Clinical Global Impression [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ]
- Patient Global Impression [ Time Frame: Weeks 0, 1, 3, 6, 8, 10, 12 ]
- Hamilton Rating Scale for Anxiety [ Time Frame: Weeks 0, 12 ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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; ( Other Grant/Funding Number: National Institute on Disability and Rehabilitation Research ) |
First Posted: | January 14, 2008 Key Record Dates |
Results First Posted: | January 1, 2015 |
Last Update Posted: | January 1, 2015 |
Last Verified: | December 2014 |
Keywords provided by Charles Bombardier, 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 Wounds and Injuries Depressive Disorder Depression Depressive Disorder, Major Dysthymic Disorder Mood Disorders Mental Disorders Behavioral Symptoms Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
Trauma, Nervous System Venlafaxine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |