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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depression
• Intervention / Treatment: Drug: choline alphoscerate; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hong Jin JEON; Phone Number: 82-2-3410-3586; Email: jhj.jeon@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Hong Jin JEON, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (ACTUAL): February 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: subjective memory complaints
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: 2021-10-033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No