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

Spinal Cord Injury Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00735670
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date June 2008
Completion date August 2012
View Details
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