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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05008120

Enrollment

Registered

2021-08-17

Start date

2021-10-01

Completion date

2024-03-31

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota

Keywords

Major depressive, Neurodegeneration

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.

Interventions

OTHERNo intervention

No intervention

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Hong Kong

Contacts

Primary ContactMandy Yu, MPH

mandyyu@cuhk.edu.hk852-39197593

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026