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

NCT04940039 | Completed Phase 4

• 2 other identifiers: CR108924R092670PSY4002
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 5

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

Keywords

Long-acting injectable antipsychotics; Low income countries; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Change in Clinical Global Impression Severity of Schizophrenia (CGI-SS) Score from Visit 2 (Week 1) to Visit 14 (Week 66 [End of Study {EOS}])

  The CGI-SS will be used to provide a clinical measure of the severity of schizophrenia. It is a single-item Likert scale with a 7-point range (1 indicates none to 7 indicates extreme symptoms).

  Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])

Secondary Outcomes (21)

• Mean Change in CGI-SS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])

  Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])

• Mean Change in CGI-SS Score from Visit 2 (Week 1) to Visit 6 (Week 25)

  Visit 2 (Week 1) to Visit 6 (Week 25)

• Change in Personal and Social Performance (PSP) Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])

  Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])

• Change in PSP Scale Scores from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])

  Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])

• Change in PSP Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)

  Visit 2 (Week 1) to Visit 6 (Week 25)

Study Arms (1)

Paliperidone Palmitate

EXPERIMENTAL

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.

Drug: Risperidone 3 mg; Drug: Paliperidone Palmitate 50 mg eq.; Drug: Paliperidone Palmitate 75 mg eq.; Drug: Paliperidone Palmitate 100 mg eq.; Drug: Paliperidone Palmitate 150 mg eq.; Drug: Paliperidone Palmitate 175 mg eq.; Drug: Paliperidone Palmitate 263 mg eq.; Drug: Paliperidone Palmitate 350 mg eq.; Drug: Paliperidone Palmitate 525 mg eq.

Interventions

Risperidone 3 mg DRUG

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

Paliperidone Palmitate

Paliperidone Palmitate 50 mg eq. DRUG

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

Also known as: R092670

Paliperidone Palmitate

Paliperidone Palmitate 75 mg eq. DRUG

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

Also known as: R092670

Paliperidone Palmitate

Paliperidone Palmitate 100 mg eq. DRUG

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

Also known as: R092670

Paliperidone Palmitate

Paliperidone Palmitate 150 mg eq. DRUG

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

Also known as: R092670

Paliperidone Palmitate

Paliperidone Palmitate 175 mg eq. DRUG

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

Also known as: R092670

Paliperidone Palmitate

Paliperidone Palmitate 263 mg eq. DRUG

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

Also known as: R092670

Paliperidone Palmitate

Paliperidone Palmitate 350 mg eq. DRUG

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

Also known as: R092670

Paliperidone Palmitate

Paliperidone Palmitate 525 mg eq. DRUG

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

Also known as: R092670

Paliperidone Palmitate

Eligibility Criteria

• Age: 19 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (5)

University Teaching Hospital of Butare(CHUB)

Butare, NAP, Rwanda

Location

Kibuye Referral Hospital

Kibuye, POBOX44, Rwanda

Location

CARAES Ndera Neuro-Psychiatric Hospital

Kigali, 423, Rwanda

Location

University Teaching Hospital of Kigali

Kigali, KN4, Rwanda

Location

Rwamagana Provincial Hospital

Rwamagana, Rwanda

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoxazoles; Azoles

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 25, 2021
• Study Start: July 22, 2021
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

RW (5)