PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

NCT ID: NCT02520726

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Matched encapsulated placebo from 1-4 capsules daily

Interventions

Sertraline

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

Intervention Type: DRUG

Placebo oral capsule

Matched encapsulated placebo from 1-4 capsules daily

Intervention Type: DRUG

Other Intervention Names

Zoloft

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Brent Kious

Psychiatry Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brent M Kious, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Hospital

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

UUtahIRB0062412

Identifier Type: -

Identifier Source: org_study_id