A randomized controlled trial of sertraline for the treatment of depression in individuals with traumatic brain injury

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Journal Article
Accession No.:
Archives of Physical Medicine and Rehabilitation
Year, Volume, Issue, Page(s):
2009, vol. 90, issue 5, pp 733-740
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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 Beck 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%.
Ashman T.A., Cantor J.B., Gordon W.A., Flanagan S., Ginsberg A., Engmann C., Spielman L., Egan M., Ambrose A.F., & Greenwald B.
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