A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury: Methods and lessons learned
Model System:
TBIReference Type:
JournalAccession No.:
J69170Journal:
Journal of Spinal Cord Medicine - JSCM (formerly Journal of the American Paraplegia Society)
Year, Volume, Issue, Page(s):
, 37, 3, 247-263Publication Website:
Abstract:
Article describes the rationale, design, methods, and lessons learned in conducting a multi-site, double-blind, randomized controlled trial of venlafaxine XR to treat major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI). Across 6 participating SCI centers throughout the United States, 2,536 subjects were screened and 133 were enrolled into a twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD. The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain. The authors describe common methodological and operational challenges conducting multi-site trials and how they were addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis. The methodological and operational challenges faced and the lessons learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.
Author(s):
Bombardier, Charles H., Fann, Jesse R., Wilson, Catherine S., Heinemann, Allen W., Richards, J. Scott, Warren, Anne M., Brooks, Larry, Warms, Catherine A., Temkin, Nancy R., Tate, Denise G.