Effects of Nutrients Supplementation in Antidepressant Treated Depressive Disorder Patients

NCT04179006 | Unknown

• 1 other identifier: B-BR-108-032
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Depressive Disorder, Major

Keywords

Major depressive disorder; Supplement nutrients; Antidepressants

Outcome Measures

Primary Outcomes (13)

• Change in participant's Hamilton Rating Scale for Depression (HAM-D) score

  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; \[higher scores denote worse symptoms/signs of depression\]

  week no. 0, 2, 4, 8, 12, 16, 20, 24

• Change in participant's BW(kg), Height(cm), Waist circumference(cm), BMI (kg/m2)

  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

  week no. 0, 2, 4, 8, 12, 16, 20, 24

• Change in participant's Glucose profiles

  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)}

  week no. 0, 4, 12, 24

• Change in participant's Fasting serum leptin level (ng/mL)

  Metabolic indices

  week no. 0, 4, 12, 24

• Change in participant's Fasting serum lipid profiles

  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)

  week no. 0, 4, 12, 24

• Change in participant's Cortisol(ug/dL) level

  Metabolic indices

  week no. 0, 4, 12, 24

• Change in participant's C-peptide(ng/dL)

  Metabolic indices

  week no. 0, 4, 12, 24

• Change in participant's Inflammatory cytokines levels

  Metabolic indices; Fasting plasma C-reactive protein (CRP) level (pg/mL) + Oxytocin(pg/mL) + Leptin(mg/mL)

  week no. 0, 4, 12, 24

• Change in participants's Quality of life scale (QOLs) scores [WHOQOL-BREF]

  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; \[higher scores in each domains denote higher quality of life\]

  week no. 0, 4, 12, 24

• Change in participants's Quality of life scale (QOLs) scores [HRQOL]

  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 \[higher scores in each domains denote higher quality of life\]

  week no. 0, 4, 12, 24

• Change in participant's Cognitive performance

  Continuous Performance Test (CPT)\[visual information processing \& attentive capacity\], Finger Tapping Test (FPT), Wisconsin Card-Sorting Test (WCST)

  week no. 0, 12, 24

• Change in participant's Social cognitive functional performance

  Mayer-Salovey-Caruso emotional Intelligence Test (MSCEIT) scores; perceiving + facilitating + understanding + managing emotion

  week no. 0, 12, 24

• Change in participant's Microbiota profiles

  Fecal samples; Types of microorganisms + no. of colonies (colony-forming unit, CFU)

  week no. 0, 12, 24

Study Arms (3)

LF chocolate + antidepressant(s)

ACTIVE COMPARATOR

Participants with LF chocolate add-on to their antidepressants regimen.

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

Erinacine A-enriched Hericium chocolate + antidepressant(s)

ACTIVE COMPARATOR

Participants with Erinacine A-enriched Hericium chocolate add-on to their antidepressants regimen.

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

Plain chocolate + antidepressant(s)

PLACEBO COMPARATOR

Participants with plain chocolate add-on to their antidepressants regimen.

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

Interventions

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

3 pieces per day

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Grape King Bio Ltd.: collaborator

Study Sites (1)

National Cheng-Kung University

Tainan, 704, Taiwan

RECRUITING

Related Publications (12)

• Byers AL, Yaffe K. Depression and risk of developing dementia. Nat Rev Neurol. 2011 May 3;7(6):323-31. doi: 10.1038/nrneurol.2011.60.

  PMID: 21537355 BACKGROUND

• Gorska-Ciebiada M, Saryusz-Wolska M, Ciebiada M, Loba J. Mild cognitive impairment and depressive symptoms in elderly patients with diabetes: prevalence, risk factors, and comorbidity. J Diabetes Res. 2014;2014:179648. doi: 10.1155/2014/179648. Epub 2014 Nov 9.

  PMID: 25431771 BACKGROUND

• Chang HH, Chi MH, Lee IH, Tsai HC, Gean PW, Yang YK, Lu RB, Chen PS. The change of insulin levels after six weeks antidepressant use in drug-naive major depressive patients. J Affect Disord. 2013 Sep 5;150(2):295-9. doi: 10.1016/j.jad.2013.04.008. Epub 2013 May 9.

  PMID: 23664565 BACKGROUND

• Howren MB, Lamkin DM, Suls J. Associations of depression with C-reactive protein, IL-1, and IL-6: a meta-analysis. Psychosom Med. 2009 Feb;71(2):171-86. doi: 10.1097/PSY.0b013e3181907c1b. Epub 2009 Feb 2.

  PMID: 19188531 BACKGROUND

• Chang HH, Lee IH, Gean PW, Lee SY, Chi MH, Yang YK, Lu RB, Chen PS. Treatment response and cognitive impairment in major depression: association with C-reactive protein. Brain Behav Immun. 2012 Jan;26(1):90-5. doi: 10.1016/j.bbi.2011.07.239. Epub 2011 Aug 4.

  PMID: 21839826 BACKGROUND

• Hiles SA, Baker AL, de Malmanche T, Attia J. Interleukin-6, C-reactive protein and interleukin-10 after antidepressant treatment in people with depression: a meta-analysis. Psychol Med. 2012 Oct;42(10):2015-26. doi: 10.1017/S0033291712000128. Epub 2012 Feb 16.

  PMID: 22336436 BACKGROUND

• Fabbri C, Porcelli S, Serretti A. From pharmacogenetics to pharmacogenomics: the way toward the personalization of antidepressant treatment. Can J Psychiatry. 2014 Feb;59(2):62-75. doi: 10.1177/070674371405900202.

  PMID: 24881125 BACKGROUND

• Antypa N, Drago A, Serretti A. Genomewide interaction and enrichment analysis on antidepressant response. Psychol Med. 2014 Mar;44(4):753-65. doi: 10.1017/S0033291713001554. Epub 2013 Jul 1.

  PMID: 23809733 BACKGROUND

• Biernacka JM, Sangkuhl K, Jenkins G, Whaley RM, Barman P, Batzler A, Altman RB, Arolt V, Brockmoller J, Chen CH, Domschke K, Hall-Flavin DK, Hong CJ, Illi A, Ji Y, Kampman O, Kinoshita T, Leinonen E, Liou YJ, Mushiroda T, Nonen S, Skime MK, Wang L, Baune BT, Kato M, Liu YL, Praphanphoj V, Stingl JC, Tsai SJ, Kubo M, Klein TE, Weinshilboum R. The International SSRI Pharmacogenomics Consortium (ISPC): a genome-wide association study of antidepressant treatment response. Transl Psychiatry. 2015 Apr 21;5(4):e553. doi: 10.1038/tp.2015.47.

  PMID: 25897834 BACKGROUND

• Rogers GB, Keating DJ, Young RL, Wong ML, Licinio J, Wesselingh S. From gut dysbiosis to altered brain function and mental illness: mechanisms and pathways. Mol Psychiatry. 2016 Jun;21(6):738-48. doi: 10.1038/mp.2016.50. Epub 2016 Apr 19.

  PMID: 27090305 BACKGROUND

• Soto M, Herzog C, Pacheco JA, Fujisaka S, Bullock K, Clish CB, Kahn CR. Gut microbiota modulate neurobehavior through changes in brain insulin sensitivity and metabolism. Mol Psychiatry. 2018 Dec;23(12):2287-2301. doi: 10.1038/s41380-018-0086-5. Epub 2018 Jun 18.

  PMID: 29910467 BACKGROUND

• Jiang H, Ling Z, Zhang Y, Mao H, Ma Z, Yin Y, Wang W, Tang W, Tan Z, Shi J, Li L, Ruan B. Altered fecal microbiota composition in patients with major depressive disorder. Brain Behav Immun. 2015 Aug;48:186-94. doi: 10.1016/j.bbi.2015.03.016. Epub 2015 Apr 13.

  PMID: 25882912 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Po-See Chen, Professor

CONTACT

866-6-2353535; chenps@mail.ncku.edu.tw

Hui-Hua Chang, Professor

CONTACT

886-6-2353535; huihua@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Visiting Staff Psychiatrist of Department of Psychiatry, Professor (joint appointment) of Institute of Behavioral Medicine

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 26, 2019
• Study Start: November 14, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)