PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

Post-traumatic Stress Disorder Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02520726
• Other study ID #: UUtahIRB0062412
• Status: Terminated
• Phase: Phase 4
• First received: April 18, 2014
• Last updated: March 13, 2018
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	University of Utah Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale		Month
Secondary	Beck Scale for Suicide Ideation		1 month