A Randomized Controlled Trial of Sertraline for the Treatment of Depression in Persons With Traumatic Brain Injury

Objective: To examine the efficacy of sertraline in the treatment of depression after traumatic brain injury (TBI). Design: Double-blind, randomized controlled trial. Setting: Research center at a major urban medical center. Participants: Subjects were a referred and volunteer sample of 52 participants with TBI, a diagnosis of major depression disorder (MDD), and a score on the Hamilton Rating Scale for Depression (HAM-D) of 18 or greater. The majority of the sample was male (58%), had less than 14 years of education (73%), had incomes below $20,000 (82%), and were from minority backgrounds (75%). Approximately one third of the sample had mild brain injuries, and two thirds had moderate to severe brain injuries. The mean age was 47 +/- 11, and the mean time since injury was 17 +/- 14 years. One participant withdrew from the study because of side effects. Intervention: Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) or placebo for 10 weeks. Main Outcome Measures: The HAM-D, the Beek Anxiety Inventory, and the Life-3 quality of life (QOL). Results: No statistically significant differences were found at baseline between drug and placebo groups on baseline measures of depression (24.8 +/- 7.3 vs 27.7 +/- 7.0), anxiety (16.4 +/- 12.3 vs 24.0 +/- 14.9), or QOL (2.96 +/- 1.0 vs 2.9 +/- 0.9). The income level of those receiving placebo was significantly lower than those participants receiving medication. Analyses of covariance revealed significant changes from preintervention to posttreatment for all 3 Outcome measures (P<.001) but no group effects. Random-effects modeling did not find any significant difference in patterns of scores of the outcome measures between the placebo and medication groups. Conclusions: Both groups showed improvements in mood, anxiety, and QOL, with 59% of the experimental group and 32% of the placebo group responding to the treatment, defined as a reduction of a person's HAM-D score by 50%.