Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder
NCT ID: NCT05008120
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
55 participants
OBSERVATIONAL
2021-10-01
2024-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
No intervention
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
No intervention
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
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
65 Years
ALL
Yes
Sponsors
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Health and Medical Research Fund
OTHER_GOV
Chinese University of Hong Kong
OTHER
Responsible Party
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Professor Wing Yun Kwok
Professor
Locations
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Shatin Hospital
Shatin, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HMRF18190221
Identifier Type: -
Identifier Source: org_study_id
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