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

Completed · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT00735670

Run by

University of Michigan

People needed

34

Starts

2008-06-01

Expected to finish

2012-08-01

Last updated by the study team

2016-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Michigan Model SCI Care System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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