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

Primary Purpose

Schizophrenia

Status
Active
Phase
Phase 4
Locations
Rwanda
Study Type
Interventional
Intervention
Risperidone 3 mg
Paliperidone Palmitate 50 mg eq.
Paliperidone Palmitate 75 mg eq.
Paliperidone Palmitate 100 mg eq.
Paliperidone Palmitate 150 mg eq.
Paliperidone Palmitate 175 mg eq.
Paliperidone Palmitate 263 mg eq.
Paliperidone Palmitate 350 mg eq.
Paliperidone Palmitate 525 mg eq.
Sponsored by
Janssen-Cilag International NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Long-acting injectable antipsychotics, Low income countries, schizophrenia

Eligibility Criteria

19 Years - 34 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Teaching Hospital of Butare(CHUB)
  • Kibuye Referral Hospital
  • CARAES Ndera Neuro-Psychiatric Hospital
  • University Teaching Hospital of Kigali
  • Rwamagana Provincial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paliperidone Palmitate

Arm Description

Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their usual 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Mean Change in CGI-SS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [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).
Mean Change in CGI-SS Score from Visit 2 (Week 1) to Visit 6 (Week 25)
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).
Change in Personal and Social Performance (PSP) Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area.
Change in PSP Scale Scores from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area.
Change in PSP Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area.
Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Change in Patient Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Change in Clinician Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Change in Schizophrenia Quality of Life Scale (SQLS) Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life.
Change in SQLS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life.
Change in SQLS Score from Visit 2 (Week 1) to Visit 6 (Week 25)
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life.
Number of Participants with Treatment-emergent Adverse Events
An adverse event is any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Treatment-emergent adverse events are adverse events with onset after the initiation of treatment in observation phase and separately for initiation of paliperidone palmitate (PP) in Lead-in phase or that are a consequence of a pre-existing condition that has worsened after each treatment phase starts.
Number of Participants with Abnormalities in Clinical Laboratory Measures
Number of participants with abnormalities in clinical laboratory measures (including serum chemistry, hematology and urinalysis) will be reported.
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (temperature [oral], pulse/heart rate, and blood pressure) will be reported.
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECG will be reported.
Number of Participants with Abnormalities in Physical Examination
Number of participants with abnormalities in physical examination (including body weight, waist circumference, and height) will be reported.
Number of Participants With Pregnancy Outcome as a Safety Measure
Number of participants with pregnancy outcome will be reported.

Full Information

First Posted
June 22, 2021
Last Updated
October 10, 2023
Sponsor
Janssen-Cilag International NV
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1. Study Identification

Unique Protocol Identification Number
NCT04940039
Brief Title
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Acronym
CASPAR
Official Title
Clinical Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
May 7, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag International NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Long-acting injectable antipsychotics, Low income countries, schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paliperidone Palmitate
Arm Type
Experimental
Arm Description
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their usual 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.
Intervention Type
Drug
Intervention Name(s)
Risperidone 3 mg
Intervention Description
Participants will receive 3 mg oral risperidone tablet once daily for 3 days.
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate 50 mg eq.
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive 50 mg eq. PP1M IM injection for at least 17 weeks (maximum 25 weeks).
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate 75 mg eq.
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive 75 mg eq. PP1M IM injection for at least 17 weeks.
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate 100 mg eq.
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive 100 mg eq. PP1M IM injection for at least 17 weeks.
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate 150 mg eq.
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive 150 mg eq. PP1M IM injection for at least 17 weeks.
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate 175 mg eq.
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive 175 mg eq. PP3M IM injection up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate 263 mg eq.
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive 263 mg eq. PP3M IM injection up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate 350 mg eq.
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive 350 mg eq. PP3M IM injection up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate 525 mg eq.
Other Intervention Name(s)
R092670
Intervention Description
Participants will receive 525 mg eq. PP3M IM injection up to 24 weeks.
Primary Outcome Measure Information:
Title
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}])
Description
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).
Time Frame
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Secondary Outcome Measure Information:
Title
Mean Change in CGI-SS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Description
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).
Time Frame
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Title
Mean Change in CGI-SS Score from Visit 2 (Week 1) to Visit 6 (Week 25)
Description
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).
Time Frame
Visit 2 (Week 1) to Visit 6 (Week 25)
Title
Change in Personal and Social Performance (PSP) Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Description
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area.
Time Frame
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Title
Change in PSP Scale Scores from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Description
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area.
Time Frame
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Title
Change in PSP Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
Description
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area.
Time Frame
Visit 2 (Week 1) to Visit 6 (Week 25)
Title
Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Description
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Time Frame
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Title
Change in Patient Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Description
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Time Frame
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Title
Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
Description
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Time Frame
Visit 2 (Week 1) to Visit 6 (Week 25)
Title
Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Description
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Time Frame
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Title
Change in Clinician Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Description
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Time Frame
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Title
Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
Description
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction.
Time Frame
Visit 2 (Week 1) to Visit 6 (Week 25)
Title
Change in Schizophrenia Quality of Life Scale (SQLS) Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Description
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life.
Time Frame
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Title
Change in SQLS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Description
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life.
Time Frame
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
Title
Change in SQLS Score from Visit 2 (Week 1) to Visit 6 (Week 25)
Description
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life.
Time Frame
Visit 2 (Week 1) to Visit 6 (Week 25)
Title
Number of Participants with Treatment-emergent Adverse Events
Description
An adverse event is any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Treatment-emergent adverse events are adverse events with onset after the initiation of treatment in observation phase and separately for initiation of paliperidone palmitate (PP) in Lead-in phase or that are a consequence of a pre-existing condition that has worsened after each treatment phase starts.
Time Frame
Up to Week 66
Title
Number of Participants with Abnormalities in Clinical Laboratory Measures
Description
Number of participants with abnormalities in clinical laboratory measures (including serum chemistry, hematology and urinalysis) will be reported.
Time Frame
Up to Week 66
Title
Number of Participants with Abnormalities in Vital Signs
Description
Number of participants with abnormalities in vital signs (temperature [oral], pulse/heart rate, and blood pressure) will be reported.
Time Frame
Up to Week 66
Title
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Description
Number of participants with abnormalities in ECG will be reported.
Time Frame
Up to Week 66
Title
Number of Participants with Abnormalities in Physical Examination
Description
Number of participants with abnormalities in physical examination (including body weight, waist circumference, and height) will be reported.
Time Frame
Up to Week 66
Title
Number of Participants With Pregnancy Outcome as a Safety Measure
Description
Number of participants with pregnancy outcome will be reported.
Time Frame
Up to Week 66

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag International NV Clinical Trial
Organizational Affiliation
Janssen-Cilag International NV
Official's Role
Study Director
Facility Information:
Facility Name
University Teaching Hospital of Butare(CHUB)
City
Butare
ZIP/Postal Code
NAP
Country
Rwanda
Facility Name
Kibuye Referral Hospital
City
Kibuye
ZIP/Postal Code
POBOX44
Country
Rwanda
Facility Name
CARAES Ndera Neuro-Psychiatric Hospital
City
Kigali
ZIP/Postal Code
423
Country
Rwanda
Facility Name
University Teaching Hospital of Kigali
City
Kigali
ZIP/Postal Code
KN4
Country
Rwanda
Facility Name
Rwamagana Provincial Hospital
City
Rwamagana
Country
Rwanda

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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