A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Clinician-Administered PTSD Scale
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Sertraline (Drug)
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.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Clinician-Administered PTSD Scale
时间窗: Month
次要结局
- Beck Scale for Suicide Ideation(1 month)
研究者
Brent Kious
Psychiatry Resident
University of Utah