EUCTR2006-003999-35-DE进行中（未招募）1 期
Efficacy and safety of levetiracetam in prevention of alcohol relapse in recently detoxified alcohol dependent patients - Keppra 2
Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie0 个研究点目标入组 210 人开始时间: 2006年10月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- All
入选标准
- •ages eligible for study 18-70 years
- •meets criteria for alcohol dependence according to DSM-IV/ICD-10
- •detoxified alcohol dependent patients
- •able to provide a written informed consent
- •able to follow verbal and written instruction (incl. sufficient knowledge of German language)av
- •have a negative urine drug screen for benzodiazepines and opiates
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •alcohol withdrawal syndrome beginning or existing • Simultaneous one ambulatory or stationary curing therapy, not however participation in groups of self-helps
- •Specific ones behavior or tiefenpsychologsiche single therapy or manual-led group therapies parallel to the clinical study
- •any further substance dependence except nicotine- and/or coffeinedependence. A Substanzabusus according to the criteria of DSM-IV and/or ICD-10 is not considered as exclusion reason.
- •Ideopathi epilepsy, not however admitted alcohol withdrawal convulsions
- •Anamnesis of heavy cerebral traumas or other heavy neurological illnesses, not however alcohol-associated neurological disturbances, e.g. polyneuropathia
- •current co-medication by means of medicines, which can affect significantly withdrawal symptoms or craving or promote the abstinence,e.g. benzodiazepines, antiepileptics, neuroleptics,
- •Contraindications or heavy side effects in relation to the study medication, or hypersensitivity opposite Pyrrolidonderivate
- •Pregnancy or quiet time or insufficient contrazeption
- •Acute severe psychiatric disturbances in need of treatment of the axle I after DSM-IV
- •Acute suizidality, not convincingly arrangementable
- •Weight internal illnesses, e.g. pankreatite, pneumonia, cardiac infarct, gastrointerstinale bleedings etc.)
- •Weight kidney damage (starting from dekompensierter retention - stage 3 after that national Kidney Foundation) or heavy liver damage (starting from Child A after Child Pugh Score with living ore erring trousers)
- •Simultaneous participation or within the last 4 weeks at another clinical study, however does not exist an exclusion with previous participation in the decontamination study with Keppra ® (Keppra 1).
研究者
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