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A multicenter, real - world study on the efficacy and metabolic effects of domestic paliperidone palmitate injection in patients with schizophrenia

A multicenter, real - world study on the efficacy and metabolic effects of domestic paliperidone palmitate injection in patients with schizophrenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109923
Enrollment
Unknown
Registered
2025-09-26
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

schizophrenia

Interventions

Observation group:Injection of domestic paliperidone palmitate

Sponsors

The Brain Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Outpatient or inpatient patients with schizophrenia who meet the ICD - 10 diagnostic criteria. (2) Patients in the acute phase or stable phase of the disease. (3) Aged 18 - 65 years old (including the lower limit boundary value), regardless of gender. (4) Subjects and their guardians who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients have diagnoses of other mental disorders except schizophrenia. (2) Patients with severe physical diseases, mental retardation, mental disorders caused by organic brain diseases and physical diseases, or other abnormal indicators (AST/ALT = 2 times the upper limit of normal value, Cr > 1.2 times the upper limit of normal value, QTc interval > 450 ms in males and > 470 ms in females). (3) Patients who have ever had or currently have tardive dyskinesia (TD), neuroleptic malignant syndrome (NMS), or severe extrapyramidal adverse reactions. (4) Patients who have had allergic reactions to any antipsychotic drugs in the past. (5) Patients who have been ineffective in treatment with risperidone or paliperidone in the past. (6) Pregnant or lactating women, women planning to become pregnant; or those who cannot ensure to take effective contraceptive measures during the study. (7) Other situations where investigators consider patients unsuitable for clinical research.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome Scale;UKU Side - Effect Rating Scale;

Countries

China

Contacts

Public ContactZhenjuan Qin

The Brain Hospital of Guangxi Zhuang Autonomous Region

qzhj208205@163.com+86 150 7729 1671

Outcome results

None listed

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