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

Recruiting

• Conditions: Gut Microbiota
• Interventions: Other: No intervention

• Registration Number: NCT05008120
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-17
• Study Start: 2021-10-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDD + RBD	No intervention	1. Clinical diagnosis of lifetime major depressive disorder, based on the M.I.N.I.; 2. RBD diagnosis according to the International classification of sleep disorder (ICSD) 3rd edition, fulfilling both the clinical and video-polysomnography (vPSG) criteria; 3. Depressive symptoms onset before RBD onset
MDD	No intervention	1. Age-and sex-matched with MDD+RBD probands; 2. Lifetime diagnosis of MDD 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 other hallmark features of RBD (e.g. REM Sleep Without Atonia, RWSA) by vPSG
Health control	No intervention	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

Primary Outcome Measures

Name	Time	Method
Composition of gut microbiota	Day 0	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

Trial Locations

Locations (1)

Shatin Hospital; 🇭🇰 Shatin, Hong Kong