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临床试验/EUCTR2021-003437-10-IT
EUCTR2021-003437-10-IT进行中(未招募)1 期

PILOT STUDY ON THE EFFECTIVENESS OF CHOLINE ALFOSCERATE IN THE UNDER THRESHOLD DEPRESSION OF THE ELDERLY - n.a.

Azienda Socio Sanitaria Territoriale di Lodi0 个研究点目标入组 20 人开始时间: 2021年10月18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)
入组人数
20

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

  • 1.Age = 65 years
  • 2.From 2 to 4 depressive symptoms present for at least two weeks prior to enrollment (Judd et al., 1994)
  • 3.Mini-Mental State Examination (MMSE) score = 24
  • 4.Montreal Cognitive Assessment (MOCA) score < 26
  • 5.Patients able to understand and sign informed consent
  • 6.Informed consent signature
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • 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 20

排除标准

  • 1.Any contraindication to treatment or intolerance to choline alfoscerate
  • 2.Diagnosis of Major Depressive Episode or Dysthymia
  • 3.Diagnosis of Schizophrenia or other psychotic disorders, Bipolar Disorder or Dementia
  • 4.Alcohol / drug / substance abuse or dependence
  • 5.Severe organic disease (eg major surgery, metastatic cancer, stroke, severe neurological disorder, myocardial infarction, chronic heart failure)
  • 6.Treatment with antidepressants or psychotherapy within 2 weeks prior to recruitment
  • 7.Any condition which, in the opinion of the investigator, might put the patient at risk by participation in this study
  • 8.Patients involved in other clinical trials

研究者

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