PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims

This is a randomized, double-blind, placebo-controlled study to determine whether administration of sertraline to patients who exhibit acute stress disorder secondary to severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).

Inclusion Criteria:

• Victim of a traumatic event leading to personal injury
• Patient experienced a feeling of intense fear, hopelessness, or horror during the course of the event or immediately afterward
• Positive screen on the ASDS (for inclusion in the randomization phase); a total ASDS score of ≥ 37 (including a dissociative score of ≥ 9) will be counted as a positive screen.

Exclusion Criteria:

• Age < 18
• Pregnant women, lactating women, or women not using acceptable form of birth control
• Epilepsy or head trauma resulting in seizures
• Current or historical schizophrenia, bipolar disorder, mental retardation, OCD, eating disorders, dementia, delirium, or self-injurious behavior
• Current/previously diagnosed PTSD
• History of hypersensitivity to sertraline
• Trauma occurring > 7 days prior to likely first treatment in the randomization phase of the trial.
• Unable to provide informed consent for participation in the study protocol.
• Patient at high risk of recurrent bleeding despite surgical stabilization
• Patient with a history of serotonin syndrome
• Patient non-fluent in English
• Patient currently prescribed an antidepressant (any SSRI, SNRI, TCA, MAOI, mirtazapine, or trazodone in excess of 100mg per day)