A randomized controlled trial of sertraline to prevent posttraumatic stress disorder in burned children.

Background: This study evaluated the potential benefits of a centrally acting selective serotonin reuptake inhibitor, sertraline, versus placebo for prevention of symptoms of posttraumatic stress disorder (PTSD) and depression in burned children. This is the first controlled investigation based on our review of the early use of a medication to prevent PTSD in children. Methods: Twenty-six children aged 6-20 were assessed in a 24-week double-blind placebo-controlled design. Each child received either flexibly dosed sertraline between 25-150 mg/day or placebo. At each reassessment, information was collected in compliance with the study medication, parental assessment of the child's symptomatology and functioning, and the child's self-report of symptomatology. The protocol was approved by the Human Studies Committees of Massachusetts General Hospital and Shriners Hospitals for Children. Results: The final sample was 17 subjects who received sertraline versus 9 placebo control subjects matched for age, severity of injury, and type of hospitalization. There was no significant difference in change from baseline with child-reported symptoms; however, the sertraline group demonstrated a greater decrease in parent-reported symptoms over 8 weeks (-4.1 vs. -0.5, p = 0.005), over 12 weeks (-4.4 vs. -1.2, p = .008), and over 24 weeks (-4.0 vs. -0.2, p = 0.017). Conclusions: Sertraline was a safe drug, and it was somewhat more effective in preventing PTSD symptoms than placebo according to parent report but not child report. Based on this study, sertraline may prevent the emergence of PTSD symptoms in children.