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

NCT05008120 | Unknown DMC

• 1 other identifier: HMRF18190221
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gut Microbiota

Keywords

Major depressive; Neurodegeneration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

MDD + RBD

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

Other: No intervention

MDD

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

Other: No intervention

Health control

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

Health control; MDD; MDD + RBD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

Shatin Hospital

Shatin, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will perform 16S ribosomal RNA (rRNA) gene sequencing on the fecal microbiome of all individuals. About 20g of the stool sample will be collected from each subject in a sterile container and transferred to the laboratory as soon as possible after collection. All samples arriving in the laboratory will be placed at -80°C before DNA extraction.

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mandy Yu, MPH

CONTACT

852-39197593; mandyyu@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 17, 2021
• Study Start: October 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

HK (1)