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A randomized controlled trial of sertraline to prevent posttraumatic stress disorder in burned children
Frederick J Stoddard1, Rohini Luthra, Erica A Sorrentino
1Shriners Hospitals for Children and Harvard Medical School at Massachusetts General Hospital, Boston, Massachusetts 02114, USA. fstoddard@partners.org
Insights
This study investigated sertraline for preventing posttraumatic stress disorder (PTSD) in burned children. Parents reported fewer PTSD symptoms in children treated with sertraline compared to placebo.
Area of Science:
- Pediatric Psychology
- Child Psychiatry
- Trauma Research
Background:
- Burn injuries in children can lead to significant psychological distress, including posttraumatic stress disorder (PTSD) and depression.
- Early intervention strategies are crucial for mitigating the long-term effects of trauma in pediatric populations.
- Selective serotonin reuptake inhibitors (SSRIs) like sertraline are being explored for their potential in preventing trauma-related psychiatric conditions in children.
Purpose of the Study:
- To evaluate the efficacy of sertraline, a selective serotonin reuptake inhibitor, in preventing symptoms of posttraumatic stress disorder (PTSD) and depression in children who have experienced burns.
- To compare the effects of sertraline versus placebo in a pediatric population following traumatic burn injury.
Main Methods:
- A 24-week, double-blind, placebo-controlled study involving 26 children aged 6-20.
- Participants received either flexibly dosed sertraline (25-150 mg/day) or a placebo.
- Data collection included medication compliance, parental assessment of symptomatology and functioning, and child self-report of symptoms.
Main Results:
- The final analysis included 17 subjects in the sertraline group and 9 in the placebo group, matched for age, injury severity, and hospitalization type.
- No significant differences were found in child-reported PTSD symptoms between the sertraline and placebo groups.
- Parents reported a significantly greater decrease in PTSD symptoms in the sertraline group compared to the placebo group at 8, 12, and 24 weeks.
Conclusions:
- Sertraline was found to be a safe medication for burned children.
- Parent-reported data suggest sertraline may be effective in preventing the emergence of PTSD symptoms in children following a burn injury.
- Further research is needed to confirm these findings, as child-reported outcomes did not show significant differences.
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.
