NCT01108146已完成不适用
Monocentric, Double-blind Placebo-Controlled, Randomized Cross-Sectional Clinical Trial of Hydrocortisone (10 and 30 mg/d) in Outpatients With Posttraumatic-Stress-Disorder (PTSD)
Central Institute of Mental Health, Mannheim1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年10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
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R)
研究概览
简要总结
To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent
- •Female patients with PTSD according to DSM-IV criteria (see Appendix 2).
- •18-45 years
- •Intrusions (according to IES-R subscale Intrusions: Value: > 7
- •Ability of subject to understand character and individual consequences of the clinical trial
- •No participation in another clinical trial (up from 30 days before this trial)
排除标准
- •Lifetime diagnosis schizophrenia according to DSM-IV
- •Mental retardation
- •Body mass index < 16.5
- •Current drug and alcohol abuse and addiction
- •Life-threatening self-injurious behavior in the last 4 months
- •Suicide attempt with the strong intention to die in the last 4 months.
- •Following diseases in anamnesis: stomach ulcera or intestinal ulcera, pancreatitis, corticoid-induced psychosis, severe osteoporosis, severe hyper-tension, heart failure, myasthenia gravis, asthma bronchiale, glaucoma, cataract, diabetes mellitus, herpes simples, herpes zoster (viremic phase), renal transplantation.
- •Any pretreatment with hydrocortisone in the last 4 weeks prior to the first administration of Investiga-tional Medicinal Product.
- •Following current medication: cardiac glycosides, saluretics, antidiabetics, cumarin-derivatives, rifampicine, phenytoine, barbiturates, primidone, NSAID, salicylate and indometacine, atropine, praziquantel, chloroquine, hydroxychloroquine, mefloquine, somatropine, protireline, cyclosporine, non-depolarising muscle relaxants.
- •Pregnancy or lactation period
- •Inadequate birth control (Adequate birth control: implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner)
- •Shift working
- •Intercontinental travel within 2 weeks prior to enrollment (to avoid jet-lag)
- •History of hypersensitivity to investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- •No subject will be allowed to enrol in this trial more than once.
研究组 & 干预措施
Arm 1
Experimental
Drug: Hydrocortisone 10 mg
Group 1: Administration of Hydrocortisone and/or Placebo in the following order:
1 week placebo-1 week hydrocortisone 10 mg/d -1 week placebo - 1 week hydrocortisone 30 mg/d
干预措施: Arm 1 Hydrocortisone 10 mg (Drug)
Arm 2
Experimental
Drug: Hydrocortisone 30 mg
Group 2: Administration of Hydrocortisone and/or Placebo in the following order:
1 week hydrocortisone 30 mg/d- 1 week placebo - 1 week hydrocortisone 10 mg/d - 1 week placebo
干预措施: Arm 2 Hydrocortisone 30 mg (Drug)
结局指标
主要结局
Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R)
时间窗: 4 Years
次要结局
- Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS)(4 Years)
研究者
Christian Schmahl
Prof. Dr.
Central Institute of Mental Health, Mannheim
研究点 (1)
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