PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Post-traumatic Stress Disorder
In brief
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).
Key facts
- Study ID
- NCT02520726
- Run by
- University of Utah
- People needed
- 5
- Starts
- 2013-09-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- University of Utah Hospital — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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