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Abstract
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OBJECTIVE: To assess the role that treatment response plays in a randomized clinical trial of an anti-depressant among people with spinal cord injury (SCI) diagnosed with major depression disorder (MDD) in explaining quality of life (QOL), assessed both globally as life satisfaction and in terms of physical and mental health-related QOL.
DESIGN: Multivariable analyses were conducted, controlling for demographic, neurological and participatory factors as well as perceived functional limitations. SETTING: A 12-week randomized clinical trial of venlafaxine XR conducted at 6 centers around the U.S. PARTICIPANTS: 124 of the 133 persons who were randomized into the "Project to Improve Symptoms and Mood after Spinal Cord Injury" randomized clinical trial. All were between the ages of 18 and 64, at least one month post SCI, met the DSM IV criteria for MDD and completed the core measures used in this study. MAIN OUTCOME MEASURES: The Satisfaction with Life Scale and the SF-12's Physical and Mental Component Summary scores.
RESULTS: Reduction in depressive symptoms over the course of a 12 week trial was predictive of increased QOL, measured as life satisfaction and mental well-being, within the context of other explanatory factors. Reduction in symptoms did not explain differences in physical well-being among those with MDD, however. Perceived functional disability, explained all three indices of QOL.
CONCLUSIONS: Greater recognition has been given to QOL outcomes as endpoints of clinical trials as these often reflect participants' reported outcomes. Our findings support the association of QOL to reduction of depression symptoms among trial participants. This association differs depending upon how QOL is defined and measured, with stronger relationships observed with life satisfaction and mental well-being among those diagnosed with MDD. The lack of association between depression with physical well-being may be explained by participants' subjective interpretation of physical well-being following SCI, their expectations and perceptions of improved physical health related QOL based on the use of assistive technology. Consistent with our findings, pain is likely to play a role in decreasing physical QOL among those with incomplete injuries. The authors suggest caution in using physical well-being as an endpoint in trials among people with SCI.
Language: en |