NCT05257902

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depression

Interventions

Type	Name	Description
DRUG	choline alphoscerate	400mg bid/day
DRUG	Placebo	Placebo 1T bid/day

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-03-01
• Completion: 2024-12-01
• First posted: 2022-02-25
• Last updated: 2022-02-25