PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims
| Status: | Terminated |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | September 2013 |
| End Date: | September 2016 |
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).
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)
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