Expired Study
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Salt Lake City, Utah 84132


Purpose:

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).


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)


NCT ID:

NCT02520726


Primary Contact:

Principal Investigator
Brent M Kious, MD PhD
University of Utah


Backup Contact:

N/A


Location Contact:

Salt Lake City, Utah 84132
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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