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Clinical Trials/EUCTR2021-003437-10-IT
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.

Azienda Socio Sanitaria Territoriale di Lodi0 sites20 target enrollmentOctober 18, 2021

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.

Registry
who.int
Start Date
October 18, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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