NCT04940039

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 19 Years – 34 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Risperidone 3 mg	Participants will receive 3 mg oral risperidone tablet once daily for 3 days.
DRUG	Paliperidone Palmitate 50 mg eq.	Participants will receive 50 mg eq. PP1M IM injection for at least 17 weeks (maximum 25 weeks).
DRUG	Paliperidone Palmitate 75 mg eq.	Participants will receive 75 mg eq. PP1M IM injection for at least 17 weeks.
DRUG	Paliperidone Palmitate 100 mg eq.	Participants will receive 100 mg eq. PP1M IM injection for at least 17 weeks.
DRUG	Paliperidone Palmitate 150 mg eq.	Participants will receive 150 mg eq. PP1M IM injection for at least 17 weeks.
DRUG	Paliperidone Palmitate 175 mg eq.	Participants will receive 175 mg eq. PP3M IM injection up to 24 weeks.
DRUG	Paliperidone Palmitate 263 mg eq.	Participants will receive 263 mg eq. PP3M IM injection up to 24 weeks.
DRUG	Paliperidone Palmitate 350 mg eq.	Participants will receive 350 mg eq. PP3M IM injection up to 24 weeks.
DRUG	Paliperidone Palmitate 525 mg eq.	Participants will receive 525 mg eq. PP3M IM injection up to 24 weeks.

Timeline

• Start date: 2021-07-22
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2021-06-25
• Last updated: 2025-04-27

Locations

5 sites across 1 country: Rwanda