Clinical Question

Does sertraline (Zoloft) reduce the risk of depression in adults following traumatic brain injury (TBI)?

Bottom Line

This study found that sertraline is more effective than placebo (number needed to treat = 6) in preventing the onset of a major depressive disorder in adults following a TBI. This study included patients with mild, moderate, and severe TBI. (Level of Evidence = 1b−)

Synopsis

Depressive disorders are a common and disabling complication after TBI. These investigators identified patients (N = 94) 18 to 85 years of age with a diagnosis of closed (nonpenetrating) TBI according to Glasgow Coma Scale (GCS) scores and computed tomographic scans taken on admission. Of these 94 patients, 69 (73%) had moderate TBI (GCS score 9 to 12), 16 (17%) had mild TBI (GCS score > 12), and nine (10%) had severe TBI (GCS score < 9). Eligibility criteria included complete recovery of posttraumatic amnesia within four weeks of the injury and absence of ongoing depression. All patients randomly received (concealed allocation assignment) sertraline—titrated at 25 mg per day for five days, 50 mg per day for five days, and 100 mg per day thereafter—or matched placebo. The primary outcome was time to onset of depressive disorder as determined by standard diagnostic criteria. Individuals masked to treatment group assignment assessed all outcomes. Complete follow-up occurred for 84% of patients at 24 weeks.

Using intention-to-treat analysis, significantly fewer patients in the sertraline group developed symptoms consistent with major depression than did those in the placebo group (number needed to treat = 6; 95% confidence interval, 3.1 to 71.7). Adverse events, including dry mouth, diarrhea, and sexual dysfunction, were mild but more common in the sertraline group.

Study design: Randomized controlled trial (double-blinded)

Funding source: Government

Allocation: Concealed

Setting: Outpatient (specialty)

Reference: JorgeREAcionLBurinDIRobinsonRGSertraline for preventing mood disorders following traumatic brain injury: a randomized clinical trial. JAMA Psychiatry2016;73(10):1041–1047.