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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants. |
|
| Control Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| choline alphoscerate | Drug | 400mg bid/day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The difference between baseline and each period of visit in the score of the total Geriatric Depression Scale (GDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Jin JEON | Contact | 82-2-3410-3586 | jhj.jeon@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Jin JEON | Samsung Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005997 | Glycerylphosphorylcholine |
| ID | Term |
|---|---|
| D005994 | Glycerophosphates |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
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| Drug |
Placebo 1T bid/day |
|
total Geriatric Depression Scale (GDS), higher scores mean a worse outcome |
| between baseline and each 2weeks, 4weeks, 6weeks, 8weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| assessement AE | collected all Adverse events | between baseline and each 2weeks, 4weeks, 6weeks, 8weeks |
| D009930 |
| Organic Chemicals |
| D002241 | Carbohydrates |
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D054709 | Lecithins |
| D010713 | Phosphatidylcholines |