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A study on sequential treatment of risperidone microspheres and paliperidone palmitate in patients with schizophrenia

A study on sequential treatment of risperidone microspheres and paliperidone palmitate in patients with schizophrenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106570
Enrollment
Unknown
Registered
2025-07-25
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Schizophrenia

Interventions

paliperidone:paliperidone palmitate injection

Sponsors

Shanghai Mental Health Center
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 DSM-5 diagnostic criteria; (2) Age range for screening is 18 to 65 years old (including threshold values), with no gender restrictions; (3) At the time of enrollment, the patient had received at least 4 injections of risperidone microspheres (II) for treatment, and the PANSS scale included 8 symptoms: P1 delusions, P2 conceptual disorder, and P3 hallucinations Behavior, N1 emotional dullness, N4 social avoidance, N6 lack of spontaneity and fluency in language communication, G5 appearance and posture, G9 rating for unusual thinking content All scores are <= 3 points; (4) The subject or their guardian signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1) The patient has been diagnosed with other mental illnesses besides schizophrenia; (2) Individuals with serious physical illnesses, mental retardation, organic brain disorders, and mental disorders caused by physical illnesses; (3) Men with QTc interval>450ms and women with QTc interval>460ms; (4) History of abuse of psychoactive substances (excluding tobacco) in the past 12 months, with obvious suicidal tendencies or violent behavior; (5) Individuals who have had or currently have delayed onset motor disorders (TD), antipsychotic malignant syndrome (NMS), or severe extrapyramidal adverse reactions; (6) Patients with refractory schizophrenia, who have currently or previously used two or more antipsychotic drugs of different compounds that are ineffective after sufficient treatment The person; (7) Individuals who have previously been allergic to risperidone or paliperidone or have had ineffective treatment; (8) Pregnant or lactating women or those planning to conceive, or those who cannot guarantee effective contraception during the study period; (9) Researchers believe that patients are not suitable for other situations in clinical research.

Design outcomes

Primary

MeasureTime frame
Rating of Medication Satisfaction Questionnaire (MSQ);

Countries

China

Contacts

Public ContactDengtang Liu

Shanghai Mental Health Center

erliu110@126.com+86 180 1731 1138

Outcome results

None listed

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