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Effects of Nutrients Supplementation in Antidepressant Treated Depressive Disorder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179006
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Grape King Bio Ltd.
Information provided by (Responsible Party):
Po-See, Chen, National Cheng-Kung University Hospital

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.


Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Dietary Supplement: LF/Erinacine A-enriched Hericium/Plain chocolate + antidepressant(s) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Nutrients Supplementation in Antidepressant Treated Depressive Disorder Patients
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: LF chocolate + antidepressant(s)
Participants with LF chocolate add-on to their antidepressants regimen.
Dietary Supplement: LF/Erinacine A-enriched Hericium/Plain chocolate + antidepressant(s)
3 pieces per day

Active Comparator: Erinacine A-enriched Hericium chocolate + antidepressant(s)
Participants with Erinacine A-enriched Hericium chocolate add-on to their antidepressants regimen.
Dietary Supplement: LF/Erinacine A-enriched Hericium/Plain chocolate + antidepressant(s)
3 pieces per day

Placebo Comparator: Plain chocolate + antidepressant(s)
Participants with plain chocolate add-on to their antidepressants regimen.
Dietary Supplement: LF/Erinacine A-enriched Hericium/Plain chocolate + antidepressant(s)
3 pieces per day




Primary Outcome Measures :
  1. Change in participant's Hamilton Rating Scale for Depression (HAM-D) score [ Time Frame: week no. 0, 2, 4, 8, 12, 16, 20, 24 ]
    Depressive symptom rating; 21 items int total, eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe, while nine are scored from 0-2; [higher scores denote worse symptoms/signs of depression]

  2. Change in participant's BW(kg), Height(cm), Waist circumference(cm), BMI (kg/m2) [ Time Frame: week no. 0, 2, 4, 8, 12, 16, 20, 24 ]
    Metabolic indices; BW (to the nearest 0.1 kg), height (to the nearest 0.1 cm), and waist circumference (to the nearest 0.1 cm), weight and height will be combined to report BMI in kg/m^2

  3. Change in participant's Glucose profiles [ Time Frame: week no. 0, 4, 12, 24 ]
    Metabolic indices; HbA1c(%)+Fasting plasma glucose (mg/dl)+Fasting serum insulin concentrations (uIU/ml)+Homeostasis model assessment-estimated insulin resistance (HOMA-IR) index+Homeostasis model of assessment for pancreatic β-cell secretory function (HOMA-β) {HOMA- IR= [fasting plasma insulin level (uIn/ml)*fasting plasma glucose level (mg/dl)/405]; HOMA- IR ≥2.5 => Insulin resistance (+)} {HOMA-β= (360× fasting serum insulin [uIn/ml]) / (fasting plasma glucose [mg/dL] -63)}

  4. Change in participant's Fasting serum leptin level (ng/mL) [ Time Frame: week no. 0, 4, 12, 24 ]
    Metabolic indices

  5. Change in participant's Fasting serum lipid profiles [ Time Frame: week no. 0, 4, 12, 24 ]
    Metabolic indices; including Fasting total cholesterol(mg/dL), High density lipoprotein (HDL) cholesterol(mg/dL), Low-density lipoprotein (LDL) cholesterol(mg/dL), Triglyceride (TG) concentration(mg/dL)

  6. Change in participant's Cortisol(ug/dL) level [ Time Frame: week no. 0, 4, 12, 24 ]
    Metabolic indices

  7. Change in participant's C-peptide(ng/dL) [ Time Frame: week no. 0, 4, 12, 24 ]
    Metabolic indices

  8. Change in participant's Inflammatory cytokines levels [ Time Frame: week no. 0, 4, 12, 24 ]
    Metabolic indices; Fasting plasma C-reactive protein (CRP) level (pg/mL) + Oxytocin(pg/mL) + Leptin(mg/mL)

  9. Change in participants's Quality of life scale (QOLs) scores [WHOQOL-BREF] [ Time Frame: week no. 0, 4, 12, 24 ]
    Psychosocial variables as environment factors; Quality of Life Scale developed through the World Health Organization (WHOQOL-BREF) & Health-Related Quality of Life (HRQOL) questionnaires will be used as assessment tools WHOQOL-BREF: 4 domains will be assessed, consists of 1. Physical Health 2. Psychological 3. Social Relationship 4. Environment; [higher scores in each domains denote higher quality of life]

  10. Change in participants's Quality of life scale (QOLs) scores [HRQOL] [ Time Frame: week no. 0, 4, 12, 24 ]
    Psychosocial variables as environment factors; Quality of Life Scale developed through the World Health Organization (WHOQOL-BREF) & Health-Related Quality of Life (HRQOL) questionnaires will be used as assessment tools HRQOL: 4 domains will be assessed, consists of 1. Physical Health 2. Psychological 3. Level of independence 4. Social Relationship [higher scores in each domains denote higher quality of life]

  11. Change in participant's Cognitive performance [ Time Frame: week no. 0, 12, 24 ]
    Continuous Performance Test (CPT)[visual information processing & attentive capacity], Finger Tapping Test (FPT), Wisconsin Card-Sorting Test (WCST)

  12. Change in participant's Social cognitive functional performance [ Time Frame: week no. 0, 12, 24 ]
    Mayer-Salovey-Caruso emotional Intelligence Test (MSCEIT) scores; perceiving + facilitating + understanding + managing emotion

  13. Change in participant's Microbiota profiles [ Time Frame: week no. 0, 12, 24 ]
    Fecal samples; Types of microorganisms + no. of colonies (colony-forming unit, CFU)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179006


Contacts
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Contact: Po-See Chen, Professor 866-6-2353535 ext 5189 chenps@mail.ncku.edu.tw
Contact: Hui-Hua Chang, Professor 886-6-2353535 ext 5683 huihua@mail.ncku.edu.tw

Locations
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Taiwan
National Cheng-Kung University Recruiting
Tainan, Taiwan, 704
Contact: Po-See Chen, Professor    886-6-2353535 ext 5189    chenps@mail.ncku.edu.tw   
Contact: Hui-Hua Chang, Professor    886-6-2353535 ext 5683    huihua@mail.ncku.edu.tw   
Sponsors and Collaborators
National Cheng-Kung University Hospital
Grape King Bio Ltd.
Publications:

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Responsible Party: Po-See, Chen, Principal Investigator, Professor, Visiting Staff Psychiatrist of Department of Psychiatry, Professor (joint appointment) of Institute of Behavioral Medicine, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT04179006    
Other Study ID Numbers: B-BR-108-032
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Po-See, Chen, National Cheng-Kung University Hospital:
Major depressive disorder
Supplement nutrients
Antidepressants
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs