n.a.

PILOT STUDY ON THE EFFECTIVENESS OF CHOLINE ALFOSCERATE IN THE UNDER THRESHOLD DEPRESSION OF THE ELDERLY - n.a.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003437-10-IT

Enrollment

Registered

2021-10-18

Start date

2023-04-05

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Under threshold depression of the elderly. MedDRA version: 20.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: GLIATILIN - 10 CAPSULE GELATINA MOLLE 600 MG Product Name: GLIATILIN Product Code: [n.a.] Pharmaceutical Form: Capsule, soft INN or Proposed INN: COLINA ALFOSCERATO Current Sponsor code: n

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary objectives of the study are: 1. To evaluate whether choline alfoscerate can determine a specific improvement on the cognitive symptoms associated with subthreshold depression. 2. To evaluate whether choline alfoscerate can lead to a specific improvement in apathy associated with subthreshold depression.;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: 12 months;Main Objective: The primary objective of the study is to evaluate the efficacy of choline alfoscerate on subthreshold depression in elderly patients.	—

Measure

Time frame

Secondary Objective: The secondary objectives of the study are: 1. To evaluate whether choline alfoscerate can determine a specific improvement on the cognitive symptoms associated with subthreshold depression. 2. To evaluate whether choline alfoscerate can lead to a specific improvement in apathy associated with subthreshold depression.;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: 12 months;Main Objective: The primary objective of the study is to evaluate the efficacy of choline alfoscerate on subthreshold depression in elderly patients.

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Secondary

Measure	Time frame
Secondary end point(s): • 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. • The apathy associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from the baseline of the AES-I (Apathy Evaluation Scale-Informant) scale.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): • 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. • The apathy associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from the baseline of the AES-I (Apathy Evaluation Scale-Informant) scale.;Timepoint(s) of evaluation of this end point: 12 months

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Countries

Italy

Contacts

Public ContactSPDC, Padiglione Bignami, Ospedale

ASST Lodi

spdc@asst-lodi.it0371277352

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026