Taking people in ItalyPhase 4
Tests choline alfoscerate for mild depression symptoms in older adults
Tests choline alfoscerate in older adults with subthreshold depression symptoms.
Key facts
- Who runs it
- Azienda Socio Sanitaria Territoriale Di Lodi
- Where
- Lodi, ItalySee the site
- Registry title
- PILOT STUDY ON THE EFFECTIVENESS OF CHOLINE ALFOSCERATE IN THE UNDER THRESHOLD DEPRESSION OF THE ELDERLY
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 20 people, planned
- Started
- 17 May 2024
- Planned end
- 30 Jun 2025
- Type of study
- Interventional
- Record updated
- 22 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for older adults with mild depression, below the level of a full depression diagnosis. It tests choline alfoscerate.
- Age
- 65 years or older (the inclusion criteria say age = 65 years; the registry minimum age field says 18 Years).
- Sex
- All sexes can join.
- Disease stage
- Subthreshold depression: 2 to 4 depressive symptoms present for at least two weeks before enrollment. No diagnosis of Major Depressive Episode or Dysthymia.
- Earlier treatment
- No antidepressants or psychotherapy within 2 weeks before recruitment.
- Biomarker or test result
- MMSE score = 24 and MOCA score < 26.
Main reasons for not taking part
- Diagnosis of Major Depressive Episode or Dysthymia
- Diagnosis of Schizophrenia or other psychotic disorders, Bipolar Disorder or Dementia
- Alcohol, drug or substance abuse or dependence
- Severe organic disease, such as stroke, metastatic cancer or myocardial infarction
- Contraindication or intolerance to choline alfoscerate
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
- Azienda Socio Sanitaria Territoriale di LodiLodi, ItalyTaking people
About the trial
What the trial wants to find out
The primary objective of the study is to evaluate the efficacy of choline alfoscerate on subthreshold depression in elderly patients.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- PILOT STUDY ON THE EFFECTIVENESS OF CHOLINE ALFOSCERATE IN THE UNDER THRESHOLD DEPRESSION OF THE ELDERLY
- Plain-language title
- Tests choline alfoscerate for mild depression symptoms in older adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 22 August 2025