Escitalopram in the prevention of posttraumatic stress disorder: a pilot randomized controlled trial.

Background: A small literature suggests that pharmacotherapy may be useful in the prophylaxis of posttraumatic stress disorder in patients presenting with major trauma. There is relatively little data, however, on the use of selective serotonin reuptake inhibitors (SSRIs) in this context.
Methods: 24 week, double-blind placebo controlled study. 31 participants presenting immediately after trauma, and meeting diagnostic criteria for full or partial acute stress disorder were randomized to treatment with 10-20 mg of escitalopram or placebo daily for 24 weeks. 2 participants were excluded from the analysis due to early drop out, leaving 29 participants (escitalopram = 12, placebo = 17) for inclusion in an intent- to- treat analysis. Participants were followed up until 56 weeks, and assessed with the Clinician Administered PTSD Scale (CAPS). A mixed model repeated measures analysis of variance (RMANOVA) was undertaken to determine the efficacy of the intervention on the CAPS score.
Results: There was a significant reduction in CAPS score over the course of treatment (F(7, 142) = 41. 58, p < 0.001) in both the escitalopram and placebo groups, with a greater reduction in CAPS score in the placebo group F(7, 142) = 2.12, p = 0.045. There were improvements on all secondary measures, including the Clinical Global Impressions scale, and scales assessing depression, anxiety and disability. Only functional disability outcomes (F(7, 141) = 2.13, p = .04), were significantly different between treatment and placebo groups. In the sample as a whole, improvement in scores were maintained at the 52 week follow-up. Side effects were comparable between the groups.
Conclusions: These data are consistent with other recent work indicating that the SSRIs may not be efficacious in the prevention of PTSD. Nevertheless, the small sample size and baseline differences between groups limit the explanatory power of the study. Although a consideration of the possibility of medication prophylaxis in PTSD remains important, both from conceptual and clinical perspectives, caution is needed with regards to the use of SSRIs until their efficacy can be proven.
Trial Registration: Clinical Trials NCT00300313.