Donepezil Double Blind Trial for ECT Memory Disfunction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Data will be analyzed using SPSS for Windows.
研究概览
简要总结
This is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ECT.
Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ECT. Several parameters will be invistigated at baseline: general psychopathological measures, memory function scales, side effects scales. The same measurements will be taken throughout the trial and one month after ending the ECT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Schizophrenia, Schizoaffective disorder, schizophreniform disorder patients who meet criteria for diagnoses by DSM-IV criteria and evaluated by the Structured Clinical Interview for DSM-IV (SCID)
排除标准
- •History of serious neurological disorders including neurodegenerative deseases, mental retardation, substance and/or alcohol dependence.
- •Pregnant women
- •Patients who recieved ECT within 6 month
- •Patients whith contraindication to Donepezil treatment.
- •Patients with Lithium treatment
研究组 & 干预措施
Donepezil
干预措施: Donepezil (Drug)
placebo
干预措施: Donepezil (Drug)
结局指标
主要结局
Data will be analyzed using SPSS for Windows.
时间窗: after 5 ECT treatments
Results of the memory and neurocognitive measures will be examined
时间窗: after 8 ECT treatments
using repeated MANOVA with before, within and after ECT treatment.
时间窗: 1 month after the last ECT treatment
次要结局
未报告次要终点