Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05257902
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 60 years
2. Diagnosed as MDD under the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed with MINI-Depression
3. HAM-D ≥ 14
4. MMSE ≥ 20
5. Who had continuous subjective memory complaints more than 6 months before the period of screening
6. Who had taking antidepressants longer than 1 month in the period of screening
Exclusion Criteria:
1. Diagnosed as schizophrenia, bipolar disorder, PTSD, OCD or other significant mental disorder under the criteria of DSM-5 (only the participants who had depressive disorder, sleep disorder, and the anxiety disorder are allowed to be included)
2. Who have medically unstable disease (only the participants, who have diabetes mellitus or hypertension under control with stable medication for 3 months could be included)
3. Diagnosed as dementia or mild cognitive impairment
4. Participants who are already taking choline alfoscerate within 6 months of period
5. Participants who have been taking medication of antipsychotics (including quetiapine), mood stabilizer, cognitive enhancer including donepezil, rivastigamine, galantamine, and memantine within 1months.
6. Participants who had previous history of liver disease or renal disease
7. Participants who had allergic reaction to choline alfoscerate
8. Other specific condition, which could be inappropriate for the trial inclusion, under the judgement of the principal investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
70 Years
Study:
NCT05257902
Study Brief:
Protocol Section:
NCT05257902