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临床试验/EUCTR2012-005723-33-NL
EUCTR2012-005723-33-NL进行中(未招募)1 期

Efficacy of amantadine on behavioural and emotional problems and impairment of executive functioning due to acquired brain injury to the frontal lobes: a series of single case experimental design studies.

GGZ Oost Brabant0 个研究点目标入组 40 人开始时间: 2014年10月1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
40

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

入选标准

  • Subjects have suffered acquired brain damage due to various aetiologies as verified by CT or MRI • Subjects suffer from emotional lability/irritability, aggressiveness, apathy as established through clinical observation and/or impairment of executive functioning as established by clinical judgement or on the basis of neuropsychological assesment. • Subjects are >3 months post injury • Subjects are 18 years or older • Written informed consent is given
  • 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 40
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Current drug addiction
  • Current psychoses • The current use of incompatible medications: methylphenidate, typical or atypical antipsychotics, combination diuretics (hydrochlorthiazide + potassium sparing diuretics) or Levodopa. • Pregnancy and lactation • Cardiac disease. Inclusion only after the consulting cardiologists consent • Refractory epilepsy • Kidney failure (eGFR<10 ml/min) • A history of gastric ulceration • Current glaucoma • Hypersensitivity to amantadine or any of the excipients

研究者

发起方
GGZ Oost Brabant

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