search
Back to results

PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

Primary Purpose

Post-traumatic Stress Disorder

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Placebo oral capsule
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-traumatic Stress Disorder focused on measuring Posttraumatic stress disorder, PTSD, Sertraline, Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Utah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sertraline

Placebo

Arm 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

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.

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale

Secondary Outcome Measures

Beck Scale for Suicide Ideation

Full Information

First Posted
April 18, 2014
Last Updated
March 13, 2018
Sponsor
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT02520726
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Posttraumatic stress disorder, PTSD, Sertraline, Burns

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertraline
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Matched encapsulated placebo from 1-4 capsules daily
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale
Time Frame
Month
Secondary Outcome Measure Information:
Title
Beck Scale for Suicide Ideation
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent M Kious, MD PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

We'll reach out to this number within 24 hrs