drugset / Trial / NCT04940039
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
NaSingle-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2021-07-22
- Primary completion
- 2024-04-16
- Completion
- 2024-04-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 3 mg | Oral |
| Subject | paliperidone palmitate | Unknown | 50 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 75 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 100 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 150 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 175 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 263 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 350 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 525 mg | Intramuscular |