2025-520899-25-00招募中4 期
PILOT STUDY ON THE EFFECTIVENESS OF CHOLINE ALFOSCERATE IN THE UNDER THRESHOLD DEPRESSION OF THE ELDERLY
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary objective will be evaluated through the analysis of the changes at the final visit from the baseline of the following tests: HAMD-17 (Hamilton Depression Rating Scale-17 items).
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of choline alfoscerate on subthreshold depression in elderly patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age = 65 years
- •From 2 to 4 depressive symptoms present for at least two weeks prior to enrollment (Judd et al., 1994)
- •Mini-Mental State Examination (MMSE) score = 24
- •Montreal Cognitive Assessment (MOCA) score < 26
- •Patients able to understand and sign informed consent
- •Informed consent signature
排除标准
- •Any contraindication to treatment or intolerance to choline alfoscerate
- •Diagnosis of Major Depressive Episode or Dysthymia
- •Diagnosis of Schizophrenia or other psychotic disorders, Bipolar Disorder or Dementia
- •Alcohol / drug / substance abuse or dependence
- •Severe organic disease (eg major surgery, metastatic cancer, stroke, severe neurological disorder, myocardial infarction, chronic heart failure)
- •Treatment with antidepressants or psychotherapy within 2 weeks prior to recruitment
- •Any condition which, in the opinion of the investigator, might put the patient at risk by participation in this study
- •Patients involved in other clinical trials
结局指标
主要结局
The primary objective will be evaluated through the analysis of the changes at the final visit from the baseline of the following tests: HAMD-17 (Hamilton Depression Rating Scale-17 items).
The primary objective will be evaluated through the analysis of the changes at the final visit from the baseline of the following tests: HAMD-17 (Hamilton Depression Rating Scale-17 items).
次要结局
- • The depression symptoms associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from baseline of the following tests: GDS-15 (Geriatric Depression Scale-15 items); CGI-s (Clinical Global Impression-severity). • The cognitive symptoms associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from baseline of the following tests: MOCA (Montreal Cognitive Assessment) scale.
研究者
Dr. Giancarlo Cerveri
Scientific
Azienda Socio Sanitaria Territoriale Di Lodi
研究点 (1)
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