PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Sertraline

Criteria

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)