PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

NCT02520726 | Terminated Phase 4 Results

• 1 other identifier: UUtahIRB0062412
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-traumatic Stress Disorder

Keywords

Posttraumatic stress disorder; PTSD; Sertraline; Burns

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale

  Month

Secondary Outcomes (1)

• Beck Scale for Suicide Ideation

  1 month

Study Arms (2)

Sertraline

EXPERIMENTAL

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

Drug: Sertraline

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo oral capsule

Interventions

Sertraline DRUG

\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.

Also known as: Zoloft

Sertraline

Placebo oral capsule DRUG

Matched encapsulated placebo from 1-4 capsules daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Burns

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Brent Kious, MD
• Organization: University of Utah

brent.kious@hsc.utah.edu

801-585-1418

Study Officials

• Brent M Kious, MD PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatry Resident

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: August 13, 2015
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 10, 2018
• Results First Posted: April 10, 2018

Record last verified: 2017-12

Locations

US (1)