Schizophrenia
Conditions
Interventions
Olanzapine cohort:None
Switching subcohort:None
Non-olanzapine antipsychotic cohort:None
Sponsors
Affiliated Kangning Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the diagnostic criteria for schizophrenia according to DSM-5 or ICD-10/11; 2.First-episode schizophrenia or no prior systematic antipsychotic treatment, or only extremely limited prior exposure; 3.Aged 18–65 years; 4.Initiation of antipsychotic monotherapy, with the main cohort receiving olanzapine monotherapy and the control cohort receiving non-olanzapine antipsychotic monotherapy, such as risperidone or aripiprazole. The switching subcohort will include patients who undergo medication switching during clinical treatment, including switching from a non-olanzapine antipsychotic to olanzapine, or switching from olanzapine to another antipsychotic; 5.Able to cooperate with clinical follow-up, physical measurements, and biological sample collection; 6.Provision of written informed consent by the participant or their legal representative.
Exclusion criteria
Exclusion criteria: 1.Previous long-term or systematic antipsychotic treatment, making it difficult to determine the baseline status; 2.Presence of severe physical diseases, such as severe hepatic, renal, or cardiovascular diseases, that may significantly affect body weight, metabolic status, or study safety; 3.Presence of endocrine diseases known to affect body weight or metabolism, such as uncontrolled diabetes mellitus or thyroid dysfunction; 4.Recent use of medications or agents that may significantly affect the gut microbiota, bile acid metabolism, or body weight, such as long-term antibiotics, probiotics/prebiotics, glucocorticoids, or weight-loss medications; 5.Presence of severe gastrointestinal diseases, malabsorption disorders, or recent acute infections; 6.Pregnancy or lactation; 7.Inability to cooperate with follow-up visits, sample collection, or clinical data collection; 8.Any other condition judged by the investigator to be unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of weight gain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antipsychotic drug exposure;Demographic and baseline clinical data;Gut microbiota and metabolic characteristics such as bile acids;Biochemical data;Psychiatric symptom scale scores;Physical Examination and Clinical Scale Parameters;Metabolism-Related Laboratory Parameters;Biomarker-Related Observational Indicators; | — |
Countries
China
Contacts
Public ContactWang Majie
Affiliated Kangning Hospital of Ningbo University
Outcome results
None listed