Sertraline for Major Depression During the Year Following Traumatic Brain Injury: A Randomized Controlled Trial.

OBJECTIVE: Major depressive disorder (MDD) is common and associated with impaired functioning after traumatic brain injury (TBI). Few placebo-controlled antidepressant trials exist in this population. We evaluated the efficacy and tolerability of sertraline for MDD within 1 year of sustaining a TBI.

SETTING: Level I trauma center.

PARTICIPANTS: Adults with MDD within 1 year of hospitalization for complicated mild to severe TBI.

DESIGN: Randomized, double-blind, placebo-controlled trial.

MAIN MEASURES: Twelve-week treatment response on the 17-item Hamilton Depression Rating Scale. We also assessed symptom improvement and remission.

RESULTS: We randomized 62 participants: 32% sustained a severe TBI, 68% had significant anxiety, 63% had a history of prior MDD, and 69% had a history of alcohol or drug dependence. Depression significantly improved from baseline to 12 weeks in both treatment groups (P < .001). There were no significant differences between the sertraline and placebo groups over 12 weeks on depression severity, response, or remission. The sertraline group had significant improvement on speed of information processing compared with the placebo group (P < .006).

CONCLUSION: Sertraline monotherapy was not superior to placebo for MDD in people with post-acute complicated mild to severe TBI. Research is needed on the effectiveness of interventions that also address the significant psychosocial needs of this population.