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Hand Microbiota-Gut-Brain Axis in Depression: Mechanisms and Effects

Hand Microbiota-Gut-Brain Axis in Depression: Mechanisms and Effects

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115227
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-12-28
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Healthy controls group :N/A

Sponsors

Zhongda Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Patient Group: 1. Hospitalized patients. 2. Aged 18-65 years (inclusive), regardless of gender. 3. Meet the diagnostic criteria for Major Depressive Disorder (MDD) as per DSM-5. 4. Screening and baseline Hamilton Depression Rating Scale (HAMD-24) total score >=20. 5. No history of electroconvulsive therapy (ECT). 6. No use of psychiatric medications within two weeks prior to enrollment. 7. No use of medications known to affect gut microbiota within one week prior to enrollment. 8. Informed consent form signed by the patient or their legal guardian. Inclusion Criteria for Healthy Control Group: 1. Healthy individuals matched to the patient group for gender, age, and education level, with a HAMD-24 total score < 8. 2. No history of severe cardiac, cerebral, or renal diseases. 3. No history of alcohol or substance abuse. 4. No family history of mental disorders. 5. Informed consent form signed by the individual or their legal guardian.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Patient Group: 1. History of schizophrenia, alcohol, or substance dependence. 2. Presence of severe suicidal behavior or ideation. 3. History of organic brain disease. 4. Severe abnormalities in cardiac, hepatic, or renal function. 5. Women who are pregnant or breastfeeding. 6. Patients with metabolic syndrome (e.g., diabetes, pathological obesity, etc.). 7. Presence of severe gastrointestinal diseases or a history of relevant surgeries affecting gastrointestinal function. 8. Use of medications known to affect gut microbiota within the past 3 months. Exclusion Criteria for Healthy Control Group: 1. History of schizophrenia, alcohol, or substance dependence. 2. History of organic brain disease. 3. Severe abnormalities in cardiac, hepatic, or renal function. 4. Women who are pregnant or breastfeeding. 5. Individuals with metabolic syndrome (e.g., diabetes, pathological obesity, etc.). 6. Presence of severe gastrointestinal diseases or a history of relevant surgeries affecting gastrointestinal function. 7. Use of medications known to affect gut microbiota within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Hamilton depression scale ;Hand Microbiota;Gut microbiota ;Metabolites;CircRNA;

Countries

China

Contacts

Public ContactYonggui Yuan

Zhongda Hospital Affiliated to Southeast University

yygylh2000@sina.com+86 139 1393 9082

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026