EUCTR2005-004501-28-DE进行中（未招募）1 期
Study to compare the efficacy of ziprasidone (Zeldox) and aripiprazole (Abilify) on cognitive functioning and quality of sleep in the treatment of schizophrenic patients
Department of Psychiatry, Ludwig-Maximilians-University Munich0 个研究点目标入组 60 人开始时间: 2007年6月21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
- 60
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
- •-Patients with diagnosis of schizophrenia according to the DSM-IV criteria (295.x)
- •-patients in need of a switch of antipsychotic medication due to side effects or lack of efficacy
- •- both male and female patients, aged 18 to 65 years
- •- provision of written informed consent
- •- women of childbearing potential must be using a reliable method of contraception
- •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
- •-risk of suicide or aggressive behaviour
- •-need of additional antipsychotic drug treatment other than study drug after randomisation
- •-treatment with antidepressants
- •-diagnosis of substance abuse or dependence within the last three months prior to baseline according to the DSM-IV criteria (305.xx)
- •-organic CNS disease, history of psychosurgery
- •-pregnancy or lactation
- •-participation in any drug trial within the last 30 days prior to baseline
- •-known HIV infection, hepatitis B or C, cancer
- •-elevation of bilirubin, GOT or GPT of more than one standard deviation beyond the reference range
- •-Leukopenia
- •-known idiopathic or medication-induced agranulocytosis
- •-known intolerance of ziprasidone or aripiprazole
- •- known QT-prolongation
- •- congenital QT-syndrome
- •- recent myocardial infarct
- •- uncompensated cardiac insufficiency
- •- heart rhythm disturbance treated with antiarrhythmic medication class IA and III
- •- concomitant treatment with medicinal products leading to QT-prolongation as antiarrhythmic medication class IA and III, Arsentrioxid, Halofantrin, Levomethadylacetat, Mesoridazin, Thioridazin, Pimozid, Sparfloxazin, Gatifloxazin, Moxifloxazin, Dolasetronmesilat, Mefloquin, Sertindol or Cisaprid
研究者
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