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Clinical Effectiveness of Choline Alphoscerate for Older Adults With Major Depression and Subjective Memory Complaints (CHOLDEPS)

Primary Purpose

Major Depression

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

choline alphoscerate

Placebo

About this trial

This is an interventional treatment trial for Major Depression focused on measuring subjective memory complaints

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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 6 months of period
Participants who have been taking medication of antipsychotics (including quetiapine), 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment group

Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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

The difference between baseline and each period of visit in the score of the Mini-Mental State Examination(MMSE)

Mini-Mental State Examination(MMSE)

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

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

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)

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)

assessement AE

collected all Adverse events

Full Information

NCT ID

NCT05257902

First Posted

January 17, 2022

Last Updated

February 16, 2022

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05257902

Brief Title

Clinical Effectiveness of Choline Alphoscerate for Older Adults With Major Depression and Subjective Memory Complaints

Acronym

CHOLDEPS

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression

Keywords

subjective memory complaints

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Active Comparator

Arm Description

Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants.

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

choline alphoscerate

Intervention Description

400mg bid/day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 1T bid/day

Primary Outcome Measure Information:

Title

Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression

Description

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

Time Frame

between baseline and 8weeks

Secondary Outcome Measure Information:

Title

The difference between baseline and each period of visit in the score of the first questionnaire of Memory Functioning Questionnaire (MFQ)

Description

first questionnaire of Memory Functioning Questionnaire (MFQ)

Time Frame