EUCTR2014-004393-41-BE进行中(未招募)1 期
A double-blind, placebo-controlled study of the impact of prophylactic treatment with Galantamine 8mg of cognitive impairment during an electroconvulsive therapy (ECT) in patients with major depressive disorder (MDD).
CUB Hospital Erasme0 个研究点开始时间: 2015年4月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
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
- •The subjects enrolled in the study will be major patients (>or= 18year) with major depressive disorder diagnosed according to DSM-IV, receiving electroconvulsive therapy.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Exclusion criteria are refusing to participate, lack of knowledge of French or an inability to respond to a type evaluation ACE-r (illiteracy, etc.), patients Patient who are forbiden to use the treatment because of disease such as heartburn, insufficient liver or kidney, COPD or active asthma, symptomatic urinary retention, bradycardia defined as heart rate less than 60 / min or block or QTc prolongation in ECG.
- •The patient with schizoaffective disorder, defined according to DSM-IV-TR will also be excluded.
- •Pregnant patients or patients without contraception during the therapy will not be included in the trial.
- •We will exclude patients with deterioration of memory before the treatment. That is to say, all the patients with MMSE less than 25. If this score is between 25 and 30, we will select patients over 82 in the ACE-r with a maximum score of obligation question Q5 and Q23 of the CEA to ensure the encoding capacity and a good recovery information before ECT.
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