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