Schizophrenia
Conditions
Interventions
Observation group:None
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Outpatients or inpatients with schizophrenia who meet the ICD-10 diagnostic criteria; 2.Patients in the acute or stable phase of the disease; 3.Age 18-65 years (including boundary values), gender is not limited; 4.Subjects are taking or planning to take Xyrem® for treatment, whether used in combination with other antipsychotic drugs or not; patients are allowed to use other medications as needed based on their condition, including but not limited to antipsychotics, mood stabilizers, antidepressants, anxiolytics, antiepileptics, and medications for other underlying conditions. All concomitant medications should be recorded in the concomitant medication section of the CRF. Common medications used to manage EPS include diphenhydramine, scopolamine injections, biperiden, and promethazine. 5.Subjects or their guardians who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patient has a diagnosis of other psychiatric disorders other than schizophrenia; 2.Individuals with severe physical illnesses, mental developmental delays, psychiatric disorders caused by organic brain or physical diseases, or other abnormal indicators (AST/ALT >= 2 times the upper limit of normal, Cr > 1.2 times the upper limit of normal, QTc interval > 450 ms for men, > 470 ms for women); 3.History of psychoactive substance abuse in the past 12 months, with significant suicidal tendencies or violent behavior; 4.Those who have had or are currently experiencing tardive dyskinesia (TD), antipsychotic malignant syndrome (NMS) or severe extrapyramidal adverse reactions; 5.Patients with refractory schizophrenia, i.e., those who have been or have been ineffective after an adequate course of treatment with two or more antipsychotic drugs of two or more different compounds; 6.Those who have had an allergic reaction to any antipsychotic drugs in the past; 7.Those who have not responded to previous treatment with risperidone or paliperidone; 8.Pregnant or lactating females or those planning to become pregnant; or those who cannot guarantee effective contraception during the study period; 9.Other conditions that, in the opinion of the investigator, the patient are not suitable for the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schizophrenia efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Schizophrenia outcome; | — |
Countries
China
Contacts
Public ContactAn Cuixia
The First Hospital of Hebei Medical University
Outcome results
None listed