CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 93 enrolled
Drug / intervention
Risperidone 3 mg +8 moredrug
Likely dose
Risperidone 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04940039
NCT04940039Phase 4Completed
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Clinical Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings

Janssen-Cilag International NV·interventional·Posted Jun 25, 2021·Updated Apr 27, 2025

In Brief

A Phase 4 clinical trial evaluating Risperidone 3 mg, Paliperidone Palmitate 50 mg eq., and 7 other interventions for Schizophrenia. Completed, enrolled 93 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesRwanda
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedJun 25, 2021
Enrollment StartJul 22, 2021
Primary CompletionApr 16, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.0 years ago

Interventions

Risperidone 3 mgdrug

Participants will receive 3 mg oral risperidone tablet once daily for 3 days.

Paliperidone Palmitate 50 mg eq.drug

Participants will receive 50 mg eq. PP1M IM injection for at least 17 weeks (maximum 25 weeks).

Paliperidone Palmitate 75 mg eq.drug

Participants will receive 75 mg eq. PP1M IM injection for at least 17 weeks.

Paliperidone Palmitate 100 mg eq.drug

Participants will receive 100 mg eq. PP1M IM injection for at least 17 weeks.

Paliperidone Palmitate 150 mg eq.drug

Participants will receive 150 mg eq. PP1M IM injection for at least 17 weeks.

Paliperidone Palmitate 175 mg eq.drug

Participants will receive 175 mg eq. PP3M IM injection up to 24 weeks.

Paliperidone Palmitate 263 mg eq.drug

Participants will receive 263 mg eq. PP3M IM injection up to 24 weeks.

Paliperidone Palmitate 350 mg eq.drug

Participants will receive 350 mg eq. PP3M IM injection up to 24 weeks.

Paliperidone Palmitate 525 mg eq.drug

Participants will receive 525 mg eq. PP3M IM injection up to 24 weeks.