PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

Study Overview
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Brief Summary
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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).

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

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Drug: Sertraline
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sertraline<br>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<br>* < 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.<br>* Other names: Zoloft;|
| Placebo Comparator: Placebo<br>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<br>* Matched encapsulated placebo from 1-4 capsules daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale |  | Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Scale for Suicide Ideation |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Posttraumatic stress disorder, Sertraline, Burns