Status:
UNKNOWN
Clinical Effectiveness of Choline Alphoscerate for Older Adults With Major Depression and Subjective Memory Complaints
Lead Sponsor:
Samsung Medical Center
Conditions:
Major Depression
Eligibility:
All Genders
60-70 years
Phase:
NA
Brief Summary
To evaluate the efficacy of choline alphoscerate on improving symptoms related to depression, anxiety, and subjective memory complaints compared to placebo in patients with Major Depressive Disorder(M...
Detailed Description
This clinical trial will include the participants over age 60, diagnosed as MDD under treatment of antidepressant longer than 1 month's period, assessed as Hamilton Rating Scale for Depression(HAM-D) ...
Eligibility Criteria
Inclusion
- Age ≥ 60 years
- Diagnosed as MDD under the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed with MINI-Depression
- HAM-D ≥ 14
- MMSE ≥ 20
- Who had continuous subjective memory complaints more than 6 months before the period of screening
- Who had taking antidepressants longer than 1 month in the period of screening
Exclusion
- 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)
- 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)
- Diagnosed as dementia or mild cognitive impairment
- Participants who are already taking choline alfoscerate within 6 months of period
- Participants who have been taking medication of antipsychotics (including quetiapine), mood stabilizer, cognitive enhancer including donepezil, rivastigamine, galantamine, and memantine within 1months.
- Participants who had previous history of liver disease or renal disease
- Participants who had allergic reaction to choline alfoscerate
- Other specific condition, which could be inappropriate for the trial inclusion, under the judgement of the principal investigator
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05257902
Start Date
March 1 2022
End Date
December 1 2024
Last Update
February 25 2022
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