NCT04940039CompletedPhase 4
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Clinical Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
The purpose of this study is to assess the long-term symptomatic response (Visit 2 \[Week 1\] to Visit 14/Week 66 \[End of Study {EOS}\]) measured by change in the Clinical Global Impressions -Severity for Schizophrenia (CGI-SS) in participants with schizophrenia who are treated in Rwandan real-world healthcare settings with the antipsychotic regimen that starts with oral anti-psychotic (AP) formulation followed by continued treatment with (paliperidone palmitate 1-month \[PP1M\] and 3-month \[PP3M\] formulations).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 93 (actual)
- First submitted
- 22 Jun 2021
- Start date
- 22 Jul 2021
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- Janssen-Cilag International NV
- Diseases
- Schizophrenia
- NCT number
- NCT04940039
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 93
- From 22 Jul 2021 to the primary completion date, 16 Apr 2024
- 5 sites 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.
Prior treatment
- Has a physical, mental, or legal incapacity that prevents a valid consent or capacity to complete about 12 months of treatment with antipsychotic medication and compliance with this study protocol
- Received an investigational intervention including investigational vaccines or used an invasive investigational medical device within 30 days before the planned first dose of study intervention, or is currently enrolled in an investigational study
- Poor prior response to risperidone or paliperidone
Other illness
- History of organic brain syndromes, comorbid psychiatric and/or physical illnesses, or significant comorbid substance abuse that is likely to interfere with understanding of or compliance with study requirements
- Known allergies, hypersensitivity, or intolerance to risperidone or paliperidone palmitate or its excipients
Other
- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study intervention
Who the study is looking for
- Diagnosis of schizophrenia by Mini International Neuropsychiatric Interview (MINI)-Screen / MINI (Module K) that requires treatment initiation or a change in treatment to better address safety, efficacy, or adherence limitations of current treatment
- Eligible for treatment in the Rwandan mental healthcare system
- At least moderately ill as measured by the Clinical Global Impression - Severity of Schizophrenia (CGI-SS) scale for schizophrenia (rating of greater than or equal to \[\>=\] 4). This criterion needs to be re-confirmed at Visit 2
- Has a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition, provide economic/cost of care information, and is expected to be with the participant for greater than \[\>\] 24 hours each week for the duration of the study)
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) during screening
- Able to give consent to participate in a clinical study that includes treatment with risperidone and long-acting injectable (LAI) formulations of paliperidone palmitate. Participants must be willing to receive injections. The participant and the caregiver must sign their own informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Age in the registry: 19 years to 34 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Teaching Hospital of Butare(CHUB) Coordinator of this site? Confirm its status | Butare | Rwanda | Unknown status |
| Kibuye Referral Hospital Coordinator of this site? Confirm its status | Kibuye | Rwanda | Unknown status |
| University Teaching Hospital of Kigali Coordinator of this site? Confirm its status | Kigali | Rwanda | Unknown status |
| CARAES Ndera Neuro-Psychiatric Hospital Coordinator of this site? Confirm its status | Kigali | Rwanda | Unknown status |
| Rwamagana Provincial Hospital Coordinator of this site? Confirm its status | Rwamagana | Rwanda | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.