EUCTR2021-003437-10-IT
Active, not recruiting
Phase 1
PILOT STUDY ON THE EFFECTIVENESS OF CHOLINE ALFOSCERATE IN THE UNDER THRESHOLD DEPRESSION OF THE ELDERLY - n.a.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Azienda Socio Sanitaria Territoriale di Lodi
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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