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Effects of Nutrients Supplementation in Antidepressant Treated Depressive Disorder Patients

NCT04179006 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-09-10

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled to evaluate the potential role of nutrients supplementation (LF chocolate /Erinacine A-enriched Hericium Erinaceus chocolate) on the therapeutic efficacy of antidepressants in major depressive disorder(MDD).

120 subjects who meet all the inclusion and exclusion criteria will be randomized into three categories, receiving 3 pieces of supplement nutrients-added or plain chocolates per day for a period of 24 weeks in total. The three categories are as follow:

1. LF chocolate
2. Erinacine A-enriched Hericium Erinaceus chocolate
3. Plain chocolate without any supplementary nutrients added (placebo group) These MDD patients will continue their antidepressant regimen throughout the study.

Symptom rating, blood samples for antidepressant-related/depressive disorder-related genome profiles identification, as well as for biomarkers assessment for metabolic indices, questionnaires and tests for psychosocial variables identification and patient's cognitive and social cognitive function or performance determination, will be carried out before and at certain time points within the 24-week tracking period. Patient's fecal samples will be acquired to recognize and to distinguish the alterations of these MDD patients microbiota profiles over the 24-week period.

Conditions

  • Depressive Disorder, Major

Interventions

DIETARY_SUPPLEMENT

LF/Erinacine A-enriched Hericium/Plain chocolate + antidepressant(s)

3 pieces per day

Sponsors & Collaborators

  • Grape King Bio Ltd.

    collaborator INDUSTRY

  • National Cheng-Kung University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179006 on ClinicalTrials.gov