Examining gut bacteria in major depression with and without sleep disorders
Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder: Tracing a Subtype of Depression With Underlying Neurodegeneration
This study looks at the differences in gut bacteria between people with major depression who also have sleep problems and those who don't, to see how it relates to their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT05008120 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify differences in gut microbiota compositions between two subtypes of major depressive disorder (MDD): those with rapid eye movement sleep behavior disorder (RBD) and those without. The study will involve a case-control design, comparing patients with MDD+RBD, patients with MDD only, and healthy controls, all matched by age and sex. Researchers will analyze the gut microbiota's abundance and composition, alongside assessing the severity of depressive symptoms and potential markers of neurodegeneration. No interventions will be administered, as the focus is on observational data collection.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with major depressive disorder, with or without rapid eye movement sleep behavior disorder.
Not a fit: Patients with severe psychiatric illnesses or those with a history of neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the relationship between gut microbiota and major depressive disorders, potentially leading to new therapeutic strategies.
How similar studies have performed: While the relationship between gut microbiota and mental health is an emerging field, this specific comparison of MDD subtypes with and without RBD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Shatin
- Shatin Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Mandy Yu, MPH
- Email: mandyyu@cuhk.edu.hk
- Phone: 852-39197593
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.