Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder

Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder: Tracing a Subtype of Depression With Underlying Neurodegeneration

The purpose of this study is to identify the variations in gut microbiota compositions between two subtypes of major depressive disorder.

Study Overview

• Status: Recruiting
• Conditions: Gut Microbiota
• Intervention / Treatment: Other: No intervention

Detailed Description

Objective: To identify the variations in gut microbiota compositions between two subtypes of major depressive disorder (MDD), namely those with and without REM sleep behavior disorder (RBD). To correlate the microbiota composition with depressive severity and prodromal markers of α-synucleinopathy.

Design: Case-control study Setting: Established clinical cohorts consisting of patients with comorbid MDD+RBD and MDD only and a group of sexand age-matched healthy control Participants: Patients with comorbid MDD+RBD (n=55), patients with MDD only (n=55), and healthy control (n=55).

Main outcome measures: The abundance and composition of gut microbiota, severity of depressive symptoms, and prodromal markers of α-synucleinopathy.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Mandy Yu, MPH; Phone Number: 852-39197593; Email: mandyyu@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Shatin Hospital
    • Contact: Mandy Yu, MPH; Phone Number: 852-26367593; Email: mandyyu@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The subjects of the current study would be recruited from our established cohort of patients with MDD (with and without RBD). Three groups of subjects are included in the current study, namely healthy control, patients with MDD only, and patients with MDD+RBD.

Description

Inclusion Criteria:

1. Age-and sex-matched with MDD+RBD subjects;
2. Free of psychiatric disorders based on M.I.N.I.;
3. Without a personal history or a family history of RBD or neurodegenerative diseases (i.e. dementia and PD)
4. Free of RBD symptoms or RWSA by vPSG

Exclusion Criteria:

1. Presence of narcolepsy and other neurodegenerative diseases that may give rise to RBD and RWSA;
2. Severe psychiatric illness that could not permit a valid written informed consent or otherwise is not suitable for participating in a study;
3. Use of antibiotics within one month and the use of probiotics within three days prior to sample collection;
4. Pre-existing or post-operation of gastrointestinal diseases (e.g. inflammatory bowel disease, gastrointestinal cancer).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MDD + RBD; Clinical diagnosis of lifetime major depressive disorder, based on the M.I.N.I.;; RBD diagnosis according to the International classification of sleep disorder (ICSD) 3rd edition, fulfilling both the clinical and video-polysomnography (vPSG) criteria;; Depressive symptoms onset before RBD onset	Other: No intervention; No intervention
MDD; Age-and sex-matched with MDD+RBD probands;; Lifetime diagnosis of MDD based on M.I.N.I.;; Without a personal history or a family history of RBD or neurodegenerative diseases (i.e. dementia and PD); Free of RBD symptoms or other hallmark features of RBD (e.g. REM Sleep Without Atonia, RWSA) by vPSG	Other: No intervention; No intervention
Health control; Age-and sex-matched with MDD+RBD subjects;; Free of psychiatric disorders based on M.I.N.I.;; Without a personal history or a family history of RBD or neurodegenerative diseases (i.e. dementia and PD); Free of RBD symptoms or RWSA by vPSG	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composition of gut microbiota	Colonic fecal bacterial composition across two heterogeneous groups of MDD (with and without RBD) and a group of the sex- and age-matched healthy controls	Day 0

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Health and Medical Research Fund

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Neurodegeneration; Major depressive
• Additional Relevant MeSH Terms: Mood Disorders; Depressive Disorder; Mental Disorders; Depressive Disorder, Major
• Other Study ID Numbers: HMRF18190221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be handled and stored under Department of Psychiatry and PI will be responsible for the safekeeping.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No