KCT0007062
Not yet recruiting
未知
Evaluation of clinical effectiveness of choline alphoscerate for older adults with major depression and subjective memory complaints: a double-blinded, placebo-controlled, Randomization, multicenter Investigator-initiated trial
ConditionsMental and behavioural disorders
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Mental and behavioural disorders
- Sponsor
- Samsung Medical Center
- Enrollment
- 120
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
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
Outcomes
Primary Outcomes
Not specified
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