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.
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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