Expired Study
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Salt Lake City, Utah 84132


Purpose:

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).


Criteria:

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 is Available At:


Original ID:

UUtahIRB0062412


NCT ID:

NCT02520726


Secondary ID:


Study Acronym:


Brief Title:

PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Utah


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Insufficient enrollment


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

5


Enrollment Type:

Actual


Overall Contact Information

Official Name:Brent M Kious, MD PhD
Principal Investigator
University of Utah

Study Dates

Start Date:September 2013
Completion Date:September 2016
Completion Type:Actual
Primary Completion Date:September 2016
Primary Completion Type:Actual
Verification Date:December 2017
Last Changed Date:March 13, 2018
First Received Date:April 18, 2014
First Results Date:December 5, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Beck Scale for Suicide Ideation
Time Frame:1 month
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clinician-Administered PTSD Scale
Time Frame:Month
Safety Issues:False

Study Interventions

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

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description: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.
Study Arm Type:Experimental
Arm Name:Sertraline
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Utah

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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