Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia

Launched by JIANGSU PROVINCE NANJING BRAIN HOSPITAL · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether switching from daily oral antipsychotic pills to a long-acting injection called Paliperidone Palmitate can help people with schizophrenia. The goal is to see if this injection works well to control symptoms and also improves social functioning, which means how well participants interact and get along with others in their daily lives.

People who might join this study are adults aged 18 to 65 who have been diagnosed with schizophrenia and are currently stable while taking oral antipsychotic medications (except clozapine). Participants should not have other serious mental health conditions or physical illnesses that could affect the study. If they agree to take part, they will switch from their daily pills to receiving the injection and will be closely monitored for how well the treatment works and how it affects their social life. This study is not yet recruiting participants but aims to offer a simpler treatment option that might make managing schizophrenia easier for some people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Outpatients or inpatients meeting DSM-5 diagnostic criteria forschizophrenia;
• • 2. Aged 18-65 years (inclusive), regardless of gender;
• • 3. Currently receiving first- or second-generation oral antipsychotics (excluding clozapine) with stable condition as assessed by the investigator, and PANSS total score ≤80 at screening and baseline;
• • 4. Signed informed consent by the patient and/or guardian;
• Exclusion Criteria:
• • 1. Comorbid psychiatric diagnoses other than schizophrenia;
• • 2. Severe physical diseases, intellectual disability, organic brain disorders, or mental disorders due to physical illnesses;
• • 3. QTc interval \>450 ms (male) or \>460 ms (female);
• • 4. History of psychoactive substance abuse (excluding tobacco) within the past 12 months, or significant suicidal/violent tendencies;
• • 5. Current or history of tardive dyskinesia (TD), neuroleptic malignant syndrome (NMS), or severe extrapyramidal symptoms (EPS);
• • 6. Treatment-resistant schizophrenia (failure of ≥2 adequate antipsychotic regimens of different compounds);
• • 7. Hypersensitivity or inefficacy to risperidone or paliperidone; 8. Pregnancy, lactation, planned pregnancy, or failure to use effective contraception during the study;
• • 9. Other conditions deemed unsuitable by the investigator. \|