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

NCT ID: NCT04940039

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2024-04-16

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone Palmitate

Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.

Group Type: EXPERIMENTAL

Risperidone 3 mg

Intervention Type: DRUG

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

Paliperidone Palmitate 50 mg eq.

Intervention Type: DRUG

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

Paliperidone Palmitate 75 mg eq.

Intervention Type: DRUG

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

Paliperidone Palmitate 100 mg eq.

Intervention Type: DRUG

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

Paliperidone Palmitate 150 mg eq.

Intervention Type: DRUG

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

Paliperidone Palmitate 175 mg eq.

Intervention Type: DRUG

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

Paliperidone Palmitate 263 mg eq.

Intervention Type: DRUG

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

Paliperidone Palmitate 350 mg eq.

Intervention Type: DRUG

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

Paliperidone Palmitate 525 mg eq.

Intervention Type: DRUG

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

Interventions

Risperidone 3 mg

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

Intervention Type: DRUG

Paliperidone Palmitate 50 mg eq.

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

Intervention Type: DRUG

Paliperidone Palmitate 75 mg eq.

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

Intervention Type: DRUG

Paliperidone Palmitate 100 mg eq.

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

Intervention Type: DRUG

Paliperidone Palmitate 150 mg eq.

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

Intervention Type: DRUG

Paliperidone Palmitate 175 mg eq.

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

Intervention Type: DRUG

Paliperidone Palmitate 263 mg eq.

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

Intervention Type: DRUG

Paliperidone Palmitate 350 mg eq.

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

Intervention Type: DRUG

Paliperidone Palmitate 525 mg eq.

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

Intervention Type: DRUG

Other Intervention Names

R092670; R092670; R092670; R092670; R092670; R092670; R092670; R092670

Eligibility Criteria

Inclusion Criteria

• Diagnosis of schizophrenia by Mini International Neuropsychiatric Interview (MINI)-Screen / MINI (Module K) that requires treatment initiation or a change in treatment to better address safety, efficacy, or adherence limitations of current treatment
• Eligible for treatment in the Rwandan mental healthcare system
• At least moderately ill as measured by the Clinical Global Impression - Severity of Schizophrenia (CGI-SS) scale for schizophrenia (rating of greater than or equal to [>=] 4). This criterion needs to be re-confirmed at Visit 2
• Has a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition, provide economic/cost of care information, and is expected to be with the participant for greater than [>] 24 hours each week for the duration of the study)
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) during screening
• Able to give consent to participate in a clinical study that includes treatment with risperidone and long-acting injectable (LAI) formulations of paliperidone palmitate. Participants must be willing to receive injections. The participant and the caregiver must sign their own informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria

• Has a physical, mental, or legal incapacity that prevents a valid consent or capacity to complete about 12 months of treatment with antipsychotic medication and compliance with this study protocol
• History of organic brain syndromes, comorbid psychiatric and/or physical illnesses, or significant comorbid substance abuse that is likely to interfere with understanding of or compliance with study requirements
• Known allergies, hypersensitivity, or intolerance to risperidone or paliperidone palmitate or its excipients
• Received an investigational intervention including investigational vaccines or used an invasive investigational medical device within 30 days before the planned first dose of study intervention, or is currently enrolled in an investigational study
• Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study intervention
• Poor prior response to risperidone or paliperidone

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

University Teaching Hospital of Butare(CHUB)

Butare, , Rwanda

Kibuye Referral Hospital

Kibuye, , Rwanda

CARAES Ndera Neuro-Psychiatric Hospital

Kigali, , Rwanda

University Teaching Hospital of Kigali

Kigali, , Rwanda

Rwamagana Provincial Hospital

Rwamagana, , Rwanda

Countries

Rwanda

Other Identifiers

R092670PSY4002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108924

Identifier Type: -

Identifier Source: org_study_id