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

Major Depression Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05257902
• Other study ID #: 2021-10-033
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2022
• Source: Samsung Medical Center
• Contact: Hong Jin JEON
• Phone: 82-2-3410-3586
• Email: jhj.jeon[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• choline alphoscerate
400mg bid/day
• Placebo
Placebo 1T bid/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	assessement AE	collected all Adverse events	between baseline and each 2weeks, 4weeks, 6weeks, 8weeks