NCT07075237Not yet recruitingPhase 4
Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia
A Study on the Efficacy and Functional Recovery of Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 11 Jul 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT07075237
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 1 Oct 2025 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Comorbid psychiatric diagnoses other than schizophrenia;
- Severe physical diseases, intellectual disability, organic brain disorders, or mental disorders due to physical illnesses;
- History of psychoactive substance abuse (excluding tobacco) within the past 12 months, or significant suicidal/violent tendencies;
- Current or history of tardive dyskinesia (TD), neuroleptic malignant syndrome (NMS), or severe extrapyramidal symptoms (EPS);
- Treatment-resistant schizophrenia (failure of ≥2 adequate antipsychotic regimens of different compounds);
- 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. \|
Lab values
- QTc interval \>450 ms (male) or \>460 ms (female);
Who the study is looking for
- Outpatients or inpatients meeting DSM-5 diagnostic criteria forschizophrenia;
- Aged 18-65 years (inclusive), regardless of gender;
- 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;
- Signed informed consent by the patient and/or guardian;
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Brain Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.