Clinical trial NCT04179006: Effects of Nutrients Supplementation in Antidepressant Treated Depressive Disorder Patients
Official title: Effects of Nutrients Supplementation in Antidepressant Treated Depressive Disorder Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Major depressive disorder
Supplement nutrients
Antidepressants
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Grape King Bio Ltd.
First posted: 2019-11-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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:

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. 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.

Eligibility criteria: Inclusion Criteria:

* Major depressive disorder (MDD) outpatients meet DSM- criteria
* Hamilton Rating Scale for Depression (HAM-D) ≥ 7
* Start to receive fluoxetine or venlafaxine or those who have received the SSRI or SNRI antidepressants

Exclusion Criteria:

* (A) had DSM-5 diagnosis for substance abuse within the past three months;
* (B) had taken monoamine oxidase inhibitors;
* (C) had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness;
* (D) had a surgical condition or a major physical illness;
* (E) pregnant or breast-feeding.

Primary outcomes:
measure: Change in participant's Hamilton Rating Scale for Depression (HAM-D) score
timeFrame: week no. 0, 2, 4, 8, 12, 16, 20, 24
measure: Change in participant's BW(kg), Height(cm), Waist circumference(cm), BMI (kg/m2)
timeFrame: week no. 0, 2, 4, 8, 12, 16, 20, 24
measure: Change in participant's Glucose profiles
timeFrame: week no. 0, 4, 12, 24
measure: Change in participant's Fasting serum leptin level (ng/mL)
timeFrame: week no. 0, 4, 12, 24
measure: Change in participant's Fasting serum lipid profiles
timeFrame: week no. 0, 4, 12, 24
measure: Change in participant's Cortisol(ug/dL) level
timeFrame: week no. 0, 4, 12, 24
measure: Change in participant's C-peptide(ng/dL)
timeFrame: week no. 0, 4, 12, 24
measure: Change in participant's Inflammatory cytokines levels
timeFrame: week no. 0, 4, 12, 24
measure: Change in participants's Quality of life scale (QOLs) scores [WHOQOL-BREF]
timeFrame: week no. 0, 4, 12, 24
measure: Change in participants's Quality of life scale (QOLs) scores [HRQOL]
timeFrame: week no. 0, 4, 12, 24
measure: Change in participant's Cognitive performance
timeFrame: week no. 0, 12, 24
measure: Change in participant's Social cognitive functional performance
timeFrame: week no. 0, 12, 24
measure: Change in participant's Microbiota profiles
timeFrame: week no. 0, 12, 24
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
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