Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
Spinal Cord Injury
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring SCI
Eligibility 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
Sites / Locations
- University of Michigan Model SCI Care System
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Venlafaxine
Placebo
Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.