Project to Improve Symptoms and Mood after Spinal Cord Injury (PRISMS)
Why is this study needed?
Depression rates in people with spinal cord injury (SCI) higher than in the general population. Depression is linked to adverse outcomes including poor subjective health, poor community integration, higher rates of medical complications and higher rates of suicide. Surprisingly there are no randomized controlled trials of treatments for MDD to guide the care of people with SCI. Despite the widespread use of antidepressants in this population, the common assumption that antidepressant medications are effective and well-tolerated among people with SCI is uncertain.
How will this study help patients and rehabilitation stakeholders?
This study may help scientists to better understand how well the study drug, Venlafaxine XR (more commonly known as Effexor XR), works on people who have had a spinal cord injury.
What are the project objectives?
The purpose of the study is to examine the efficacy and tolerability of the study as a treatment for Major Depressive Disorder. This study consists of two parts:
- A 15-minute screening interview that can be done in person or over the phone to determine eligibility. Agreeing to participate in this screening portion of our study does not require you to participate in the larger study that involves taking the study drug.
- A 12 week study that will involve 7 visits to the Rehabilitation Institute of Chicago. As a subject in this study you will be asked to participate in several sessions in which study staff will ask you personal questions. If after the initial interview, you qualify for the treatment portion of our study, we will ask you to take part in a physical examination by a nurse practitioner, which may include a blood test if you have not had certain tests done in the last 6 months. If after your physical examination the nurse practitioner determines you are still eligible to participate, you will be given either the study drug, Venlafaxine XR (more commonly known as Effexor XR) or a placebo. A placebo looks like the study drug but is an inactive substance that has no medication.
What are the expected outcomes of this project?
The final outcome assessment will be conducted after 12 weeks of treatment. The primary outcome analysis will compare the proportion of responders (those who report greater than 50% reduction in depressive symptoms from baseline to the end of treatment) in the experimental versus placebo control groups.
What agency funded the project?
National Institute on Disability and Rehabiliation Research (NIDRR)
NIDRR Grant Number: H133A060107
What is the duration of the project?
December 1, 2006 – November 30, 2011
Primary Project Staff
Allen Heinemann, Ph.D., Program Director & Principal Investigator, Rehabilitation Institute of Chicago
For members of the media