.a.

Phase 1

• Conditions: nder threshold depression of the elderly.; MedDRA version: 20.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-003437-10-IT
• Lead Sponsor: Azienda Socio Sanitaria Territoriale di Lodi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-18
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified