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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05257902
Other study ID # 2021-10-033
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2022
Est. completion date December 2024

Study information

Verified date February 2022
Source Samsung Medical Center
Contact Hong Jin JEON
Phone 82-2-3410-3586
Email jhj.jeon@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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(MDD) accompanied with subjective cognitive decline, who are over the age of 60.


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) ≥ 14, and Mini-Mental State Examination(MMSE) ≥ 20, and those who are accompanied with subjective memory complaints. The investigators will evaluate the clinical efficacy of symptomatic improvement in depression, anxiety, and subjective memory complaints. The investigators will assess these outcomes including memory function, depression, anxiety, and satisfaction on medication with scales comparing control group with treatment group under 8 weeks of medication. This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV trial to evaluate the efficacy. Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants. Participants in the control group will take the placebo, which would not affect their medical condition, for the adjunctive therapy is the choice of agreement between clinician and participants. If there is the necessity of change in antidepressant or of adjustment of their dosage, investigator can stop the clinical trial and proceed to another treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 2024
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years to 70 Years
Eligibility 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

Study Design


Intervention

Drug:
choline alphoscerate
400mg bid/day
Placebo
Placebo 1T bid/day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression between the baseline and visit 5, higher scores mean a worse outcome between baseline and 8weeks
Secondary The difference between baseline and each period of visit in the score of the first questionnaire of Memory Functioning Questionnaire (MFQ) first questionnaire of Memory Functioning Questionnaire (MFQ) between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Secondary The difference between baseline and each period of visit in the score of the total Geriatric Depression Scale (GDS) total Geriatric Depression Scale (GDS), higher scores mean a worse outcome between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Secondary The difference between baseline and each period of visit in the score of the Mini-Mental State Examination(MMSE) Mini-Mental State Examination(MMSE) between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Secondary The difference between baseline and each period of visit in the score of the Hamilton Rating Scale for Depression(HAM-D) Hamilton Rating Scale for Depression(HAM-D), normal: 0~6 score, mild: 7~18 score, moderate: 18-24 score, severe: above 25 score between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Secondary The difference between baseline and each period of visit in the score of the Hamilton Rating Scale for Anxiety (HAM-A) Hamilton Rating Scale for Anxiety (HAM-A), mild: below17 score, moderate: 18-24 score, severe: above 30 score between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Secondary The difference the score The difference between baseline and each period of visit in the score of the Korea version of montreal cognitive assessment (K-MoCA) between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Secondary The difference between baseline and each period of visit in the score of the total score of Medication Satisfaction Questionnaire (MSQ) total score of Medication Satisfaction Questionnaire (MSQ) between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Secondary assessement AE collected all Adverse events between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
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