drugset / Trial / NCT04940039

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

NCT04940039

Phase 4 Completed 93 enrolled Janssen-Cilag International NV
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

EvaluationDrugModalityDoseRoute
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

Indications