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

Gut Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008120
• Other study ID #: HMRF18190221
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Mandy Yu, MPH
• Phone: 852-39197593
• Email: mandyyu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Gut Microbiota
• Mental Disorders

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Hong Kong	Shatin Hospital	Shatin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Health and Medical Research Fund

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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