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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05257902
• Collaborator: (none)
• Enrollment: 120
• Arms: 2
• Anticipated Duration (Months): 33.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depression	Drug: choline alphoscerate; Drug: Placebo	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment group Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants.	Drug: choline alphoscerate; 400mg bid/day
Placebo Comparator: Control Group 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.	Drug: Placebo; Placebo 1T bid/day

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. The difference between baseline and each period of visit in the score of the first questionnaire of Memory Functioning Questionnaire (MFQ) [between baseline and each 2weeks, 4weeks, 6weeks, 8weeks]

   first questionnaire of Memory Functioning Questionnaire (MFQ)

2. The difference between baseline and each period of visit in the score of the total Geriatric Depression Scale (GDS) [between baseline and each 2weeks, 4weeks, 6weeks, 8weeks]

   total Geriatric Depression Scale (GDS), higher scores mean a worse outcome

3. The difference between baseline and each period of visit in the score of the Mini-Mental State Examination(MMSE) [between baseline and each 2weeks, 4weeks, 6weeks, 8weeks]

   Mini-Mental State Examination(MMSE)

4. The difference between baseline and each period of visit in the score of the Hamilton Rating Scale for Depression(HAM-D) [between baseline and each 2weeks, 4weeks, 6weeks, 8weeks]

   Hamilton Rating Scale for Depression(HAM-D), normal: 0~6 score, mild: 7~18 score, moderate: 18-24 score, severe: above 25 score

5. The difference between baseline and each period of visit in the score of the Hamilton Rating Scale for Anxiety (HAM-A) [between baseline and each 2weeks, 4weeks, 6weeks, 8weeks]

   Hamilton Rating Scale for Anxiety (HAM-A), mild: below17 score, moderate: 18-24 score, severe: above 30 score

6. The difference the score [between baseline and each 2weeks, 4weeks, 6weeks, 8weeks]

   The difference between baseline and each period of visit in the score of the Korea version of montreal cognitive assessment (K-MoCA)

7. The difference between baseline and each period of visit in the score of the total score of Medication Satisfaction Questionnaire (MSQ) [between baseline and each 2weeks, 4weeks, 6weeks, 8weeks]

   total score of Medication Satisfaction Questionnaire (MSQ)

8. assessement AE [between baseline and each 2weeks, 4weeks, 6weeks, 8weeks]

   collected all Adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Hong Jin JEON, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: hong jin jeon, Principal Investigator, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT05257902
• Other Study ID Numbers: 2021-10-033
• First Posted: Feb 25, 2022
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by hong jin jeon, Principal Investigator, Samsung Medical Center: subjective memory complaints
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Choline

Study Results

No Results Posted as of Feb 25, 2022