Short Title:JAMA Psychiatry (formerly Archives of General Psychiatry)
Year, Volume, Issue, Page(s):15, 72, 3, 247-258
Study examined the efficacy and tolerability of venlafaxine hydrochloride extended-release (XR) for major depressive disorder (MDD) or dysthymic disorder in people with chronic spinal cord injury (SCI). A total of 2,536 patients from outpatient clinics at 6 SCI treatment centers in the United States were screened and 133 were randomized into a 12-week trial of venlafaxine XR vs placebo using a flexible-dose algorithm. The primary depression outcome measures were the Hamilton Depression Rating Scale (HAM-D) and the Maier subscale. Secondary outcomes were self-rated depression severity, global improvement, and SCI-related disability. Mixed-effects linear regression models were used to compare treatment efficacy of venlafaxine XR with placebo Primary analyses included observations at baseline and at 1, 3, 6, 8, 10, and 12 weeks, analyzed according to the intent-to- treat principle. Severity of adverse effects (none, mild, moderate, or severe) was recorded at baseline and at each follow-up. Results revealed a significant difference between the venlafaxine XR and placebo groups in improvement on the Maier subscale from baseline to 12 weeks but not on the HAM-D. Participants receiving venlafaxine XR reported significantly less SCI-related disability at 12 weeks compared with placebo. Blurred vision was the only significantly more common new or worsening adverse effect in the venlafaxine XR group compared with the placebo group over 12 weeks. The data suggest that venlafaxine XR was well-tolerated by most patients and is an effective antidepressant for decreasing core symptoms of depression and improving SCI-related disability.