A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings

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

Outcome

Met primary endpoint

paper Over the 66 weeks FU period, CGI-SS improved significantly (mean change -1.4 (SD 0.69), 95% CI -1.50 to -1.22; p<0.001). PMID 42303401 ↗

Publications

• Bizoza R, Mehawej J, Musoni-Rwililiza E, Alphs L, Turkoz I, Sun L, Killion L, Decotelli-Mendes C, Knight RK. Efficacy and safety of long-acting injectable paliperidone palmitate 1-month and 3-month formulations in the maintenance treatment of schizophrenia: a single-arm, open-label, interventional study in Rwandan healthcare settings. BMJ Open. 2026 Jun 16;16(6):e109753. doi: 10.1136/bmjopen-2025-109753.

Drugs

Indications