Major depressive disorder (MDD) is a common, severe, and often life-threatening illness that
involves the body, mood, and thoughts. Recent reports suggested that immune dysfunction could
be linked with cognitive impairment and metabolic comorbidities, and accumulating evidence
suggested that the regulation of the microbiota- gut-brain axis has been shown to impact
inflammation and to affect brain function.
This randomized, double-blind, placebo-controlled is 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 MDD
outpatients (aged 20-70 years) from the National Cheng Kung University Hospital who meet the
Diagnostic and Statistical Manual of mental disorders, Fifth Edition (DSM-5) and Hamilton
Rating Scale for Depression (HAMD) scores ≥ 7, receiving fluoxetine or venlafaxine so as SSRI
or SNRI antidepressants will be enrolled.
Subjects who meet all the inclusion and exclusion criteria will be randomized into three
categories, with 40 subjects each, receiving 3 pieces of supplement nutrients-added or plain
chocolates (placebo) manufactured by GRAPE KING BIO LTD per day for a period of 24 weeks in
total. The three categories are as follow:
LF chocolate
Erinacine A-enriched Hericium Erinaceus chocolate
Plain chocolate without any supplementary nutrients added (placebo group) These MDD
patients will continue their antidepressant regimen throughout the study. Follow-up
visits will be arranged at week no. 0, 2, 4, 8, 12, 16, 20 and 24, in which week no. 0,
4, 12 and 24 will be the four most important re-visit timing.
Various assessments or tests will be arranged in these 24-week period. Symptom rating with
17-item Hamilton Rating Scale for Depression (HAM-D) by psychiatrist will be done at every
visits. Blood samples for antidepressant-related/depressive disorder-related genome profiles
identification, as well as for biomarkers assessment for metabolic indices, will be obtained
at week no. 0, 4, 12 and 24. Questionnaires aimed for psychosocial variables (environmental
factors) identification including social support scales (SSS), quality of life scale (QOLs)
and Recent life changes questionnaire (RCLQ) will be self-answered by patients. Continuous
Performance Test (CPT), finger-Tapping Test (FPT) and Wisconsin Card Sorting Test (WCST) will
be utilized to evaluate their cognitive performance. Mayer-Salovey-Caruso emotional
Intelligent Test (MSCEIT) will help in social cognitive function assessment. Patient's fecal
samples will be acquired at week no. 0, 4, 12 and 24 to recognize and to distinguish the
alterations in MDD patients microbiota profiles.
