Major DepressionCHOLDEPSNCT05257902
Clinical Effectiveness of Choline Alphoscerate for Older Adults With Major Depression and Subjective Memory Complaints
A study testing choline alphoscerate in people with Major Depression, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- choline alphoscerate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Aug 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 4 weeks of period
- Participants who have been taking medication of typical antipsychotics, 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, 135710
About this study
Official title: 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
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.
Read the 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) ≥ 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.
- Conditions
- Major Depression
- Being tested
- choline alphoscerate, Placebo
- Keywords
- subjective memory complaints
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choline alphoscerateDrug
400mg bid/day
PlaceboDrug
Placebo 1T bid/day
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants. Receives: Drug: choline alphoscerate |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between baseline and 8weeks
Secondary outcomes (8)
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)
Measured: 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)
total Geriatric Depression Scale (GDS), higher scores mean a worse outcome
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
assessement AE
collected all Adverse events
Measured: between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start19 Aug 2022
- Primary completion27 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hong jin jeon, Samsung Medical Center
- Investigators
- Hong Jin JEON, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257902
- Sponsor's protocol ID
- 2021-10-033
- Acronym
- CHOLDEPS
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05257902
- Acronym / sponsor ID
- CHOLDEPS / 2021-10-033
- Conditions
- Major Depression
- Keywords
- subjective memory complaints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) ≥ 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: choline alphoscerateParticipants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants. |
| Control Group | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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 4 weeks of period
- Participants who have been taking medication of typical antipsychotics, mood stabilizer, cognitive enhancer including donepezil, rivastigamine, galantamine, and memantine within 1months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| choline alphoscerate400mg bid/day | Drug | Treatment group |
| PlaceboPlacebo 1T bid/day | Drug | Control Group |
Primary outcome
Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression
Time frame: between baseline and 8weeks
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
8 secondary outcomes
The difference between baseline and each period of visit in the score of the first questionnaire of Memory Functioning Questionnaire (MFQ)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
The difference the score
Time frame: 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)
Time frame: between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
assessement AE
Time frame: between baseline and each 2weeks, 4weeks, 6weeks, 8weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Jin JEON principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing choline alphoscerate in people with Major Depression, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression (time frame: between baseline and 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.