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A multicenter and real-world study on the efficacy and safety of paliperidone palmitate injection for schizophrenia

A multicenter and real-world study on the efficacy and safety of paliperidone palmitate injection for schizophrenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092341
Enrollment
Unknown
Registered
2024-11-14
Start date
2024-11-15
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

schizophrenia

Interventions

Group of Paliperidone Palmitate:Injection of paliperidone palmitate injection

Sponsors

Henan Mental Hospital,The Second Affiliated Hospital of Xinxiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Outpatients or inpatients with schizophrenia who met the ICD-10 diagnostic criteria; (2) patients in the acute or stable phase of the disease; (3) Both male and female, aged 18-65 years old (4) Written informed consent was obtained from the patient and legal guardian, and written informed consent was obtained from the legal guardian if the patient had no insight during the onset.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) Individuals with schizophrenia, mood disorders, mental retardation, pervasive developmental disorders, delirium, dementia, memory impairment, or other cognitive impairments that meet the diagnostic criteria of ICD-10; (2) Mental disorders caused by substance abuse (alcohol, drugs, etc.), people with serious unstable physical diseases, diagnosed diabetes, thyroid disease, hypertension, heart disease, etc; (3) Narrow angle glaucoma; (4) patients with a history of epilepsy (except febrile convulsions); (5) Patients who met the diagnostic criteria of ICD-10-TR for alcohol and drug dependence (except nicotine dependence); (6) Patients who suffer from or have previously suffered from drug-induced malignant syndrome and severe late-onset motor disorders; (7) Patients with significant abnormal laboratory results (AST or ALT= 2 times of the upper limit of normal; BUN= 1.5 times the upper limit of normal; Cr= 1.2 times the upper limit of normal); (8) Unable to follow the doctor's advice, or without a guardian; (9) QTc interval prolongation (QTc=450 ms in men or =470 ms in women); (10) Pregnant or lactating women, or those planning to become pregnant; (11) Patients with contraindications to antipsychotic drugs recommended in this study; (12) Other conditions considered by the investigators to be inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
efficacy;Laboratory Examinations;

Secondary

MeasureTime frame
safety;

Countries

China

Contacts

Public ContactJingyuan Zhao

Henan Mental Hospital,The Second Affiliated Hospital of Xinxiang Medical University

13460480548@163.com+86 185 3733 9690

Outcome results

None listed

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