Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05257902
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.
Study:
NCT05257902
Study Brief:
Protocol Section:
NCT05257902