A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- University of Utah
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Clinician-Administered PTSD Scale
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Sertraline
Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age >65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration
Intervention: Sertraline (Drug)
Placebo
Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.
Intervention: Placebo oral capsule (Drug)
Outcomes
Primary Outcomes
Clinician-Administered PTSD Scale
Time Frame: Month
Secondary Outcomes
- Beck Scale for Suicide Ideation(1 month)
Investigators
Brent Kious
Psychiatry Resident
University of Utah