clozapine-induced metabolic abnormalities in schizophrenia patients
Conditions
Interventions
schizophrenia group with metabolic abnormalities produced by oral clozapine:none
schizophrenia group without metabolic abnormalities of oral clozapine:None
Sponsors
Clinical Research Center for Mental Disorders, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for the schizophrenia group with metabolic abnormalities produced by oral clozapine: (i) meeting the diagnostic criteria for schizophrenia in the International Classification of Diseases, Tenth Revision (ICD-10); (ii) Han Chinese; (iii) age 18-70 years; (iv) current single-agent oral clozapine treatment for more than 3 consecutive months; (v) meeting the International Diabetes Federation Global Diagnostic Criteria for Metabolic Syndrome (2005); and (vi) voluntary participation. 2. Inclusion criteria for the schizophrenia group without metabolic abnormalities of oral clozapine: (i) met the diagnostic criteria for schizophrenia in the International Classification of Diseases, Tenth Revision (ICD-10); (ii) Han Chinese; (iii) aged 18 to 70 years; (iv) current single-agent oral clozapine treatment had been continuous for more than 3 months; and (v) voluntary participation. 3. Inclusion criteria for the healthy adult group: (i) healthy; (ii) Han Chinese; (iii) age 18 to 70 years; (iv) voluntary participation.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for the group of schizophrenics with metabolic abnormalities produced by oral clozapine: (i) antibiotic use within the past 3 months; (ii) invasive medical intervention within the past 3 months; (iii) history of bowel cancer or inflammatory disease; and (iv) history of alcohol/drug dependence/psychoactive substance abuse. 2. Exclusion criteria for the schizophrenia group without metabolic abnormalities of oral clozapine: (i) antibiotic use within the past 3 months; (ii) invasive medical intervention within the past 3 months; (iii) history of bowel cancer or inflammatory disease; (iv) history of alcohol/drug dependence/psychoactive substance abuse; and (v) meeting the International Diabetes Federation Global Diagnostic Criteria for Metabolic Syndrome (2005). 3. Exclusion criteria for the healthy adult group: (i) current acquisition of a diagnosis of an acute or chronic disease; (ii) use of antibiotics in the past 3 months; (iii) invasive medical intervention in the past 3 months; (iv) history of alcohol/drug dependence/psychoactive substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum metabolomics data;16s Rrna gene sequencing of intestinal flora;metagenomic sequencing of intestinal flora; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum lipid levels;serum adipocytokines;serum inflammatory cytokines; | — |
Countries
People's Republic of China
Contacts
Public ContactZhidao Shi
Clinical Research Center for Mental Disorders, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Outcome results
None listed