None listed
Conditions
Interventions
Drug : Treatment group : choline alphoscerate once 400mg, bid, 8weeks
Control Group: Placebo 1T bid, 8weeks
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression (K-PDQ-D) between the baseline and visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference between baseline~V2, baseline~V3, baseline~V4 in the total score of K-PDQ-D;The difference between baseline and each period of visit in the score of the first questionnaire of Memory Functioning Questionnaire (MFQ), total Geriatric Depression Scale (GDS), Mini–Mental State Examination(MMSE), Hamilton Rating Scale for Depression(HAM-D), Hamilton Rating Scale for Anxiety (HAM-A), Korea version of montreal cognitive assessment (K-MoCA), and the total score of Medication Satisfaction Questionnaire (MSQ);Evaluation on safety | — |
Countries
Korea, Republic of
Contacts
Public ContactKyung Ui Hwang
Samsung Medical Center
Outcome results
None listed