Overview

Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury

Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
0
Participant gender:
All
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 modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Michigan
Collaborator:
U.S. Department of Education
Treatments:
Venlafaxine Hydrochloride
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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