PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

Overview

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).

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2016

Interventions

  • Drug: Sertraline
    • < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.
  • Drug: Placebo oral capsule
    • Matched encapsulated placebo from 1-4 capsules daily

Arms, Groups and Cohorts

  • Experimental: 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
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Clinician-Administered PTSD Scale
    • Time Frame: Month

Secondary Measures

  • Beck Scale for Suicide Ideation
    • Time Frame: 1 month

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Utah
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brent Kious, Psychiatry Resident – University of Utah
  • Overall Official(s)
    • Brent M Kious, MD PhD, Principal Investigator, University of Utah

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