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Cross-regional multicenter study on intestinal microbiome and metabolome mapping of patients with depression and schizophrenia in China

Cross-regional multicenter study on intestinal microbiome and metabolome mapping of patients with depression and schizophrenia in China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100427
Enrollment
Unknown
Registered
2025-04-09
Start date
2024-12-13
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

depression

Interventions

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Depression : meeting the diagnostic criteria of depression in DSM-V ; male or female subjects aged 18-60 years ( including the cut-off value ), of Han nationality ; hamilton Depression Scale ( HAMD ) score >= 18 points ; patients with first-episode depression were treated with psychiatric drugs for less than 2 weeks before admission ; the course of disease in patients with acute recurrence = 60 points ; patients with first-episode schizophrenia were treated with psychiatric drugs for less than 2 weeks before admission ; the course of disease in patients with acute recurrence <= 10 years ; 17.5 <= BMI <= 30 ; can cooperate to complete the questionnaire and sample collection ; signed informed consent form; 3.Healthy controls : aged 18-60 years, Han nationality ; can cooperate to complete the questionnaire and sample collection ; 17.5 <= BMI <= 30 ; signed informed consent form;

Exclusion criteria

Exclusion criteria: 1.Pregnant, lactating women or planned pregnancy; 2.patients with severe physical diseases, including brain organic diseases, congestive heart failure, liver and kidney failure, cancer, immune and metabolic endocrine diseases or hepatobiliary, gastrointestinal diseases, abdominal pain, diarrhea ( except functional constipation ), can refer to the laboratory abnormal indicators higher than the normal value of more than 2 times or combined with the research doctor 's opinion; 3.patients with acute and chronic infections, taking probiotics, anti-inflammatory drugs ( including steroids and non-steroidal drugs, such as aspirin, acetaminophen, ibuprofen, dexamethasone, prednisone, metronidazole, etc. ), and patients who had received antibiotic treatment for three consecutive days in the past month; 4.participants who participated in any clinical trial within 30 days before baseline; 5.meet the diagnostic criteria for other mental disorders in DSM-V ( patients with personality disorders and mental retardation ); 6.the researchers believe that there are situations that do not meet the clinical study, or that the compliance cannot meet the follow-up requirements.

Design outcomes

Primary

MeasureTime frame
Fecal metagenome;Fecal metabolome;Plasma metabolome;Fecal metatranscriptome;

Countries

China

Contacts

Public ContactFeng Zhu

The First Affiliated Hospital of Xi'an Jiaotong University

zhufeng1982@xjtu.edu.cn+86 29 85323112

Outcome results

None listed

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