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).

Conditions

• Schizophrenia

Interventions

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.

Sponsors & Collaborators

• Janssen-Cilag International NV

  lead INDUSTRY

Principal Investigators

• Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Max Age

34 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-22

Primary Completion

2024-04-16

Completion

2024-04-16

Countries

• Rwanda

Study Locations