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

University of Michigan

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Other: Placebo; Drug: Venlafaxine HCl

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00735670

NDNO60032SS

NIDRRH133N060032

Details and patient eligibility

About

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.

Full 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 identified specific clinical indications for many antidepressants currently available in the general population, little is known about the clinical indications of these agents in SCI. This study is proposed to test the benefits of Venlafaxine HCI (Effexor XR) for reducing mild to moderate symptoms of depression among people with SCI. The intervention will last 12 weeks and there will be 13 assessments and data collection points. Data will be collected at 26 weeks also. Eight face to face contacts are anticipated.

Because of the change in protocol to reducing mild to moderate symptoms and substantially lower enrollment than anticipated (1/6th of what we anticipated), we deleted a number of study outcomes listed in the 2011 posting of this study. Most of these were not part of the original posting in 2008, and those that were deleted were no longer relevant to new protocol's focus on reducing mild to moderate depression. The two outcomes reported here were most relevant to the revised protocol.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Venlafaxine

Experimental group

Description:

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.

Treatment:

Drug: Venlafaxine HCl

Placebo

Placebo Comparator group

Description:

Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.

Treatment:

Other: Placebo