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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Gut Microbiota

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05008120

HMRF18190221

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

55 participants in 3 patient groups

MDD + RBD

Description:

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

Treatment:

Other: No intervention

MDD

Description:

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

Treatment:

Other: No intervention

Health control

Description:

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

Treatment:

Other: No intervention