A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities

NCT03713658 | Completed Phase 4

• 2 other identifiers: CR108551R092670PSY4001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the feasibility of conducting a study of oral risperidone followed by paliperidone palmitate for once monthly (PP1M) and paliperidone palmitate for every 3 months (PP3M) in rwandan healthcare facilities with mental healthcare capabilities.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Successful Completion of Study Procedures

  Percentage of participants with successful completion of study procedures related to diagnosis and outcome measures assessment will be reported.

  Up to Week 46

• Percentage of Participants With Successful Delivery of Risperidone/PP1M/PP3M for the Duration of the Study

  Percentage of participants with successful delivery of risperidone/PP1M/PP3M for the duration of the study will be reported.

  Up to Week 46

• Percentage of Participants With Successful Administration of Risperidone/PP1M/PP3M Throughout the Study

  Percentage of participants with successful administration of risperidone/PP1M/PP3M throughout the study will be reported.

  Up to Week 46

• Quality of Life as Assessed by World Health Organization Quality of Life Scale Brief Version (WHO QoL-BREF) Total Score

  The WHO QoL-BREF is a 25 item scale used to assess the quality of life. All items are rated on a five-point likert scale using response categories such as 1 represents very poor and 5 represents very well with a possible maximum score of 125 and a minimum score of 25.

  Up to Week 46

• Clinician Satisfaction as Assessed by Clinician Satisfaction Rating Scale Score

  The Clinician Satisfaction Rating is a 4-item scale. Two items use a Likert scale with a six-point range from 0 (definitively not) to 6 (definitely) and two items are multiple-choice (example, "select all that apply"). The scale will be used to assess the acceptability and/or burden for the provider associated with the study including treatment with long-acting injectables (LAIs).

  Up to Week 46

Secondary Outcomes (8)

• Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI)-MINI Screen and Module K Criteria

  Up to Week 46

• Number of Participants Intended to Complete/Attend Next Visit as Assessed by Intent-to-Attend (ITA) Plus Assessment Scale

  Up to Week 46

• Direct Cost Assessment of Schizophrenia Care as Assessed by Client Service Receipt Inventory (CSRI) Scale Score

  Up to Week 46

• Indirect Cost Assessment of Schizophrenia Care as Assessed by Cost Assessment Questionnaire (CAQ)

  Up to Week 46

• Change From Baseline in Sheehan Disability Scale (SDS) Total Score

  Baseline up to Week 46

Study Arms (3)

Oral Risperidone

EXPERIMENTAL

Participants will receive 3 milligram (mg) oral risperidone tablets once daily for up to one Week to determine tolerability based on investigator review.

Drug: Risperidone 3 mg

Paliperidone Palmitate Once Monthly (PP1M)

EXPERIMENTAL

Participants will receive 50, 75, 100 or 150 mg eq. (\[paliperidone palmitate\] mg equivalent \[to paliperidone\]) long acting formulation of paliperidone palmitate once monthly (PP1M) intramuscular injection for 4 months (17 weeks) plus option to continue 3 more months if not stabilized depending on the participant's clinical safety, tolerability and efficacy requirements.

Drug: Paliperidone Palmitate 50 mg eq.; Drug: Paliperidone Palmitate 75 mg eq.; Drug: Paliperidone Palmitate 100 mg eq.; Drug: Paliperidone Palmitate 150 mg eq.

Paliperidone Palmitate Every 3 Months (PP3M)

EXPERIMENTAL

Participants will receive 175, 263, 350 or 525 mg eq. (\[paliperidone palmitate\] mg equivalent \[to paliperidone\]) long acting formulation of paliperidone palmitate every 3 months (PP3M) intramuscular injection for 24 Weeks.

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 tablets once daily for up to one Week.

Oral Risperidone

Paliperidone Palmitate 50 mg eq. DRUG

Participants will receive 50 mg eq. PP1M intramuscular injection for 17 Weeks.

Also known as: R092670

Paliperidone Palmitate Once Monthly (PP1M)

Paliperidone Palmitate 75 mg eq. DRUG

Participants will receive 75 mg eq. PP1M intramuscular injection for 17 Weeks.

Also known as: R092670

Paliperidone Palmitate Once Monthly (PP1M)

Paliperidone Palmitate 100 mg eq. DRUG

Participants will receive 100 mg eq. PP1M intramuscular injection for 17 Weeks.

Also known as: R092670

Paliperidone Palmitate Once Monthly (PP1M)

Paliperidone Palmitate 150 mg eq. DRUG

Participants will receive 150 mg eq. PP1M intramuscular injection for 17 Weeks.

Also known as: R092670

Paliperidone Palmitate Once Monthly (PP1M)

Paliperidone Palmitate 175 mg eq. DRUG

Participants will receive 175 mg eq. PP3M intramuscular injection for 24 Weeks.

Also known as: R092670

Paliperidone Palmitate Every 3 Months (PP3M)

Paliperidone Palmitate 263 mg eq. DRUG

Participants will receive 263 mg eq. PP3M intramuscular injection for 24 Weeks.

Also known as: R092670

Paliperidone Palmitate Every 3 Months (PP3M)

Paliperidone Palmitate 350 mg eq. DRUG

Participants will receive 350 mg eq. PP3M intramuscular injection for 24 Weeks.

Also known as: R092670

Paliperidone Palmitate Every 3 Months (PP3M)

Paliperidone Palmitate 525 mg eq. DRUG

Participants will receive 525 mg eq. PP3M intramuscular injection for 24 Weeks.

Also known as: R092670

Paliperidone Palmitate Every 3 Months (PP3M)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with 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 or efficacy limitations of current treatment
• Participants at least moderately ill as measured by the clinical global impressions - severity of schizophrenia (CGI-SS) scale for schizophrenia, or experiencing poorly tolerated side effects from their current medications, or having difficulty with adequate adherence to treatment, per the investigator's judgement
• Participants have a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition and is expected to be with the participant for greater than (\>) 24 hours each week for the duration of the study)
• Participants able to give consent to participate in a clinical study that includes treatment with risperidone and long-acting injectable formulations of paliperidone palmitate. Participants must be willing to receive injections. The participant and the caregiver participant must sign an 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
• Participants must be willing and able to provide responses for all self-administered questionnaires

You may not qualify if:

• Participants have 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
• Participants with 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
• Participants with known allergies, hypersensitivity, or intolerance to risperidone or paliperidone palmitate or their excipients
• Participants with poor prior response to risperidone
• Participants who received an investigational medication (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study medication, or is currently enrolled in an investigational study

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

CARAES Ndera Neuro-Psychiatric Hospital

Kigali, 423, Rwanda

Location

Ruhengeri Referral Hospital, Public Hospital

Musanze District, 57, Rwanda

Location

Kibungo Referral Hospital

Ngoma District, 10, Rwanda

Location

Related Publications (1)

• Alphs L, Turkoz I, Smith-Swintosky V, Keenan A, Abraham E, Schotte A, Hooker E, Damascene Iyamuremye J, Kayiteshonga Y, Bizoza R, Mancevski B. Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system. BMJ Open. 2023 Apr 18;13(4):e064675. doi: 10.1136/bmjopen-2022-064675.

  PMID: 37072361 DERIVED

Related Links

• A Pilot-Study in Rwandan Health Care Settings to Examine the Feasibility of a Large Pragmatic Clinical Study to Assess the Value of Paliperidone Palmitate in Rwanda

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 Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: October 18, 2018
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

RW (3)