PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

Phase 4

Terminated

• Conditions: Post-traumatic Stress Disorder
• Interventions: Drug: Placebo oral capsule; Drug: Sertraline

• Registration Number: NCT02520726
• Lead Sponsor: University of Utah

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-12
• Results First Submitted: 2017-12-05
• Results First Submitted QC: 2018-03-13
• Last Update Submitted: 2018-03-13
• Results First Posted: 2018-04-10
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral capsule	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.
Sertraline	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

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale	Month

Secondary Outcome Measures

Name	Time	Method
Beck Scale for Suicide Ideation	1 month

Trial Locations

Locations (1)

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States