NCT00362661终止不适用
Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- CAPS CGI
研究概览
简要总结
The aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients with chronic PTSD due to adult trauma; PTSD is diagnosed according to the DSM-IV, as measured with the CAPS
- •Age between 18 and 60
排除标准
- •History of disease states representing contraindications to glucocorticoid therapy (tuberculosis, gastritis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy (to exclude with a pregnancy test) and lactation, glaucoma, diabetes mellitus, thrombophilia, acute or chronic infections, hyperthyroidism, cirrhosis)
- •Severe or chronic somatic diseases
- •Topic glucocorticoid therapy (for large skin parts)
- •Inhaled glucocorticoids
- •Current psychotic, bipolar, substance-related, or severe personality disorder
- •Current severe depressive disorder
- •Severe cognitive impairment or a history of organic mental disorder
- •Evidence of PTSD or depression immediately prior to the index trauma
- •Prominent current suicidal or homicidal ideation
- •Asylum seeking status
- •Body weight >20% above or below normal range
- •Changes in psychopharmacologic or psychotherapeutic management less than 8 weeks before start of the study
结局指标
主要结局
CAPS CGI
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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