Choline alfoscerate for Subthreshold depression | Depression

Inclusion criteria

• {"criterion_text":"- 1. Age = 65 years\n- 2. From 2 to 4 depressive symptoms present for at least two weeks prior to enrollment (Judd et al., 1994)\n- 3. Mini-Mental State Examination (MMSE) score = 24\n- 4. Montreal Cognitive Assessment (MOCA) score < 26\n- 5. Patients able to understand and sign informed consent\n- 6. Informed consent signature"}

Exclusion criteria

• {"criterion_text":"- 1. Any contraindication to treatment or intolerance to choline alfoscerate\n- 2. Diagnosis of Major Depressive Episode or Dysthymia\n- 3. Diagnosis of Schizophrenia or other psychotic disorders, Bipolar Disorder or Dementia\n- 4. Alcohol / drug / substance abuse or dependence\n- 5. Severe organic disease (eg major surgery, metastatic cancer, stroke, severe neurological disorder, myocardial infarction, chronic heart failure)\n- 6. Treatment with antidepressants or psychotherapy within 2 weeks prior to recruitment\n- 7. Any condition which, in the opinion of the investigator, might put the patient at risk by participation in this study\n- 8. Patients involved in other clinical trials"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Analysis of changes at final visit from baseline measured by HAMD-17 (Hamilton Depression Rating Scale - 17 items)."}

Secondary endpoints

• {"endpoint_text":"- • 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.","definition_or_measurement_approach":"Analysis of changes at final visit from baseline measured by GDS-15 and CGI-s for depressive symptoms; analysis of changes at final visit from baseline measured by MOCA for cognitive symptoms."}

Italy

Earliest CTIS Part Ii Submission Date

28-01-2025

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

206

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Azienda Socio Sanitaria Territoriale Di Lodi

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Italfarmaco S.p.A.","duties_or_roles":"Source of monetary support; marketing authorisation holder for GLIATILIN (as listed in product information).","organisation_type":""}