Schizophrenia
Conditions
Interventions
Intervention group:Inject PP6M
Sponsors
Guangdong Provincial People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The age range is from 18 to 70 years old, with no gender restrictions. 2. Meet the diagnostic criteria for schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) for at least 6 months. 3. Schizophrenia patients undergoing outpatient or home-based rehabilitation. 4. The patient has been treated with PP3M for 3 months or more and has informed and agreed to switch to PP6M for treatment. While using long-acting injections for treatment, other antipsychotic drugs can be used in combination. 5. The body mass index (BMI) is between 17 and 40 kg/m ², and the weight is not less than 47 kg at the time of enrollment. 6. The patient himself/herself signs the informed consent form, indicating that he/she understands the purpose and required procedures of the study and is willing to participate in it (the informed consent cannot be signed by the legal representative of the subject).
Exclusion criteria
Exclusion criteria: 1. No medical records (at least: diagnosis time of schizophrenia, treatment history and recurrence-related records are required). 2. It is known that there is a hypersensitivity reaction to any excipients in paliperidone, risperidone or PP6M preparations. 3. Previously or at the time of enrollment, there were clinically significant and unstable medical conditions or relevant medical histories. 4. Attempted suicide within 12 months prior to enrollment, or having an immediate risk of suicide or violent behavior as clinically judged by the investigator at the time of screening. 5. Diagnosed with moderate or severe substance use disorder (except nicotine or caffeine) by DSM-V within 6 months before enrollment. 6. Currently, the main diagnoses of DSM-V are other diagnoses besides schizophrenia, such as dissociative disorder, bipolar disorder, depression, schizoaffective disorder, schizophrenia-like disorder, autism, primary drug-induced mental disorders and dementia-related psychosis. 7. There is a history of malignant syndrome caused by antipsychotic drugs or delayed movement disorder. 8. Schizophrenia patients who have been hospitalized for a long time. 9. Pregnant and lactating patients, those who did not take appropriate contraceptive measures during the trial, or those who have plans to have children within the next year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| non-recurring rate; | — |
Countries
China
Contacts
Public ContactJiafujun
Guangdong Provincial People’s Hospital
Outcome results
None listed