Status:
COMPLETED
Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modificati...
Detailed Description
The successes of psychological and pharmacological modes of intervention in treating depression, both alone and combined, are well documented in the literature. While a great deal of research has iden...
Eligibility Criteria
Inclusion
- Having sustained an SCI at least six months prior to enrollment.
- Neurological impairment ASIA Grades A-D.
- Mild to moderate depressive symptoms.
- English speaker
- Age 18 years or older
- Able to communicate with study personnel
Exclusion
- No neurological impairment due to SCI.
- Presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools.
- Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder).
- Medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination).
- Pregnant or unwilling to use birth control if female and sexually active.
- Presence of glaucoma.
- Prior use of study drug without success or being treated with another antidepressant medication and being unwilling to taper off to take the stud drug.
- Willing to travel to Ann Arbor Michigan.
- Expecting to take or currently taking another experimental study within 30 days
- Major surgery scheduled within 12 weeks
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00735670
Start Date
June 1 2008
End Date
August 1 2012
Last Update
October 13 2016
Active Locations (1)
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1
University of Michigan Model SCI Care System
Ann Arbor, Michigan, United States, 48109-5491