NCT01090518Unknown不适用
Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)
Bronx VA Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary diagnosis of chronic PTSD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria, resulting from a deployment-related traumatic event, and a minimum PTSD severity of 50 (CAPS).
- •The veteran must either be unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen).
排除标准
- •Lifetime history of psychotic disorder, bipolar disorder, or obsessive compulsive disorder.
- •Moderate or severe traumatic brain injury (TBI).
- •A medical or mental health problem other than PTSD that requires immediate clinical attention.
- •Substance abuse or dependence within the last 3 months.
- •Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment.
- •Persons on a psychotropic medication regimen that has not been consistent for one month.
- •Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance).
- •Unwillingness to discontinue other specialized psychotherapy for PTSD during the 10 weeks of study treatment and the 6 week follow-up. (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated.)
- •Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study.
研究组 & 干预措施
Prolonged Exposure therapy with Hydrocortisone
Active Comparator
干预措施: Prolonged Exposure therapy (Behavioral)
Prolonged Exposure therapy with Hydrocortisone
Active Comparator
干预措施: Hydrocortisone (Drug)
Prolonged Exposure therapy with placebo
Placebo Comparator
干预措施: Prolonged Exposure therapy (Behavioral)
结局指标
主要结局
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
时间窗: week 16
次要结局
- Cognitive performance (learning and retention in an episodic memory task, attention and working memory)(week 16)
- Other measures of clinical outcome, psychological state and functioning(week 16)
- Biological measures associated with PTSD severity(week 16)
研究者
Rachel Yehuda
PhD, Professor of Neuroscience and Psychiatry
Bronx VA Medical Center
研究点 (1)
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