EUCTR2007-004286-18-DE进行中（未招募）不适用
Monocentric, Double-blind Placebo-Controlled, Randomized Cross-Sectional Clinical Trial of Hydrocortisone (10 and 30mg/d) in Outpatients with Posttraumatic-Stress- Disorder (PTSD) - Hydrocortisone in the Treatment of Intrusions in Patients with PTSD
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Written Informed Consent
- •Female patients with PTSD according to DSM-IV criteria
- •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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
- •hypertension, heart failure, myasthenia gravis, asthma bronchiale,
- •glaucoma, cataract, diabetes mellitus, herpes simples, herpes zoster
- •(viremic phase), renal transplantation.
- •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.
- •Any pretreatment with hydrocortisone in the last 4 weeks prior to the first administration of the investigational medicinal product.
- •Shift working
- •Intercontinal travel within 2 weeks prior to enrolment (to avoid jet-lag)
- •Pregnancy or lactation period
- •Inadequate birth control (Adequate birth control: implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner)
- •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.
研究者
相似试验
已完成
不适用
Effect of two skin products in womeCTRI/2017/06/008809Indus Biotech Private Limited72
已完成
不适用
Double-Blind, Randomized, Placebo-Controlled, Mono-Centre Pilot (Proof-of-Concept) Study to Investigate the Effect of IMPP-1 on Immune Functions That Contribute to Resistance to (Respiratory) Infection in Healthy SubjectsHealthy SubjectsDRKS00010568Chief Executive Officer, NutriLeads B.V.60
已完成
1 期
A clinical trial to Evaluate Efficacy and Safety of AG Arbutin Cream in Skin Lightening (Melanin Reduction) In Healthy Subjects.CTRI/2009/091/000731Piramal Life Sciences Limited Mumbai36
进行中（未招募）
不适用
Randomised, double-blind, placebo-controlled, monocentric phase III study on the efficacy and safety of Lidocaine 8 mg Sore Throat Lozenges in patients with moderate to severe acute sore throat not necessarily to be treated with antibiotics - Lidocaine 8 mg sore throat lozenges vs. placeboThe study will be performed in patients suffering from acute sore throat not necessarily to be treated with antibioticsEUCTR2004-005095-17-DEEngelhard Arzneimittel GmbH & Co. KG
进行中（未招募）
不适用
CONCERTA Lab School StudyMedDRA version: 18.0Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorderSystem Organ Class: 100000004873Attention Deficit Hyperactivity DisorderEUCTR2015-001042-28-Outside-EU/EEAOrtho-McNeil Janssen Scientific Affairs LLC89