Back to resultsA Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
Primary Purpose
Schizophrenia
Status
Completed
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
About this trial
This is an interventional health services research trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CARAES Ndera Neuro-Psychiatric Hospital
- Ruhengeri Referral Hospital, Public Hospital
- Kibungo Referral Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Oral Risperidone
Paliperidone Palmitate Once Monthly (PP1M)
Paliperidone Palmitate Every 3 Months (PP3M)
Arm Description
Participants will receive 3 milligram (mg) oral risperidone tablets once daily for up to one Week to determine tolerability based on investigator review.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
Secondary Outcome Measures
Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI)-MINI Screen and Module K Criteria
The MINI-Screen is a structured and standardized diagnostic interview used to determine the most common psychiatric disorders according to axis I diagnostic and statistical manual of mental disorders-fourth edition text revision (DSM-IV-TR) and the international classification of diseases and related health problems (ICD-10). The MINI-screen will be administered to participants for preselection by a qualified psychiatric professional. If this step is passed, then Module K of MINI will be applied by a medical doctor (preferably a psychiatrist) or a psychologist in order to confirm the diagnosis of schizophrenia and to determine if there are other psychiatric conditions present. Number of participants who met MINI criteria will be assessed.
Number of Participants Intended to Complete/Attend Next Visit as Assessed by Intent-to-Attend (ITA) Plus Assessment Scale
The ITA-Plus scale is a single Likert scale question with a range of 0 indicates definitely not attending to 6 indicates definitely attending that will be used to estimate the likelihood of completing the study or attending the next visit to provides qualitative feedback on why completion/attendance may not occur. Number of participants intended to complete/attend next visit will be assessed.
Direct Cost Assessment of Schizophrenia Care as Assessed by Client Service Receipt Inventory (CSRI) Scale Score
The CSRI scale will be used to assess the costs of schizophrenia care for participants, caregivers, and health care providers, especially direct costs.
Indirect Cost Assessment of Schizophrenia Care as Assessed by Cost Assessment Questionnaire (CAQ)
The CAQ will be used to assess the costs of schizophrenia care for participants, caregivers, and health care providers, especially indirect costs.
Change From Baseline in Sheehan Disability Scale (SDS) Total Score
SDS will be used to assess the functioning of participants with schizophrenia. It has participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0 (no impairment) - 10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement.
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Safety will be assessed by AEs along with concomitant medications, past medical history, and demographics of participants who will participate in this study. An adverse event is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the medication. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Psychosis as Assessed by Mental Illness With Lay Evidence (SMILE) Scale Score
The Psychosis module of the SMILE will be used to assess the clinical symptoms of schizophrenia. It is a 15-item Likert scale covering questions to describe participants condition like if they have kept the body neat and clean, difficulty in completing routine tasks, talked to themselves etc with answers on a point range of 0 (Never) to 5 (All the time). It uses 7-day recall period. Both the participant and caregiver participant will complete this scale.
Clinical Global Impression - Severity of Schizophrenia (CGI-SS) Scale Total Score
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 (0 indicates none to 7 indicates extreme symptoms).
Full Information
NCT ID
NCT03713658
First Posted
October 18, 2018
Last Updated
March 8, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03713658
Brief Title
A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Risperidone
Arm Type
Experimental
Arm Description
Participants will receive 3 milligram (mg) oral risperidone tablets once daily for up to one Week to determine tolerability based on investigator review.
Arm Title
Paliperidone Palmitate Once Monthly (PP1M)
Arm Type
Experimental
Arm Description
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.
Arm Title
Paliperidone Palmitate Every 3 Months (PP3M)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Risperidone 3 mg
Intervention Description
Participants will receive 3 mg oral risperidone tablets once daily for up to one Week.
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 intramuscular injection for 17 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 intramuscular injection for 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 intramuscular injection for 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 intramuscular injection for 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 intramuscular injection for 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 intramuscular injection for 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 intramuscular injection for 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 intramuscular injection for 24 Weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Successful Completion of Study Procedures
Description
Percentage of participants with successful completion of study procedures related to diagnosis and outcome measures assessment will be reported.
Time Frame
Up to Week 46
Title
Percentage of Participants With Successful Delivery of Risperidone/PP1M/PP3M for the Duration of the Study
Description
Percentage of participants with successful delivery of risperidone/PP1M/PP3M for the duration of the study will be reported.
Time Frame
Up to Week 46
Title
Percentage of Participants With Successful Administration of Risperidone/PP1M/PP3M Throughout the Study
Description
Percentage of participants with successful administration of risperidone/PP1M/PP3M throughout the study will be reported.
Time Frame
Up to Week 46
Title
Quality of Life as Assessed by World Health Organization Quality of Life Scale Brief Version (WHO QoL-BREF) Total Score
Description
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.
Time Frame
Up to Week 46
Title
Clinician Satisfaction as Assessed by Clinician Satisfaction Rating Scale Score
Description
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).
Time Frame
Up to Week 46
Secondary Outcome Measure Information:
Title
Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI)-MINI Screen and Module K Criteria
Description
The MINI-Screen is a structured and standardized diagnostic interview used to determine the most common psychiatric disorders according to axis I diagnostic and statistical manual of mental disorders-fourth edition text revision (DSM-IV-TR) and the international classification of diseases and related health problems (ICD-10). The MINI-screen will be administered to participants for preselection by a qualified psychiatric professional. If this step is passed, then Module K of MINI will be applied by a medical doctor (preferably a psychiatrist) or a psychologist in order to confirm the diagnosis of schizophrenia and to determine if there are other psychiatric conditions present. Number of participants who met MINI criteria will be assessed.
Time Frame
Up to Week 46
Title
Number of Participants Intended to Complete/Attend Next Visit as Assessed by Intent-to-Attend (ITA) Plus Assessment Scale
Description
The ITA-Plus scale is a single Likert scale question with a range of 0 indicates definitely not attending to 6 indicates definitely attending that will be used to estimate the likelihood of completing the study or attending the next visit to provides qualitative feedback on why completion/attendance may not occur. Number of participants intended to complete/attend next visit will be assessed.
Time Frame
Up to Week 46
Title
Direct Cost Assessment of Schizophrenia Care as Assessed by Client Service Receipt Inventory (CSRI) Scale Score
Description
The CSRI scale will be used to assess the costs of schizophrenia care for participants, caregivers, and health care providers, especially direct costs.
Time Frame
Up to Week 46
Title
Indirect Cost Assessment of Schizophrenia Care as Assessed by Cost Assessment Questionnaire (CAQ)
Description
The CAQ will be used to assess the costs of schizophrenia care for participants, caregivers, and health care providers, especially indirect costs.
Time Frame
Up to Week 46
Title
Change From Baseline in Sheehan Disability Scale (SDS) Total Score
Description
SDS will be used to assess the functioning of participants with schizophrenia. It has participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0 (no impairment) - 10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement.
Time Frame
Baseline up to Week 46
Title
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Description
Safety will be assessed by AEs along with concomitant medications, past medical history, and demographics of participants who will participate in this study. An adverse event is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the medication. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time Frame
Up to Week 46
Title
Psychosis as Assessed by Mental Illness With Lay Evidence (SMILE) Scale Score
Description
The Psychosis module of the SMILE will be used to assess the clinical symptoms of schizophrenia. It is a 15-item Likert scale covering questions to describe participants condition like if they have kept the body neat and clean, difficulty in completing routine tasks, talked to themselves etc with answers on a point range of 0 (Never) to 5 (All the time). It uses 7-day recall period. Both the participant and caregiver participant will complete this scale.
Time Frame
Up to Week 46
Title
Clinical Global Impression - Severity of Schizophrenia (CGI-SS) Scale Total Score
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 (0 indicates none to 7 indicates extreme symptoms).
Time Frame
Up to Week 46
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
CARAES Ndera Neuro-Psychiatric Hospital
City
Kigali
ZIP/Postal Code
423
Country
Rwanda
Facility Name
Ruhengeri Referral Hospital, Public Hospital
City
Musanze District
ZIP/Postal Code
57
Country
Rwanda
Facility Name
Kibungo Referral Hospital
City
Ngoma District
ZIP/Postal Code
10
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
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR108551&attachmentIdentifier=7d07c1a7-2442-4cfe-8f26-120828a27cd7&fileName=CR108551_CSR_Synopsis.pdf&versionIdentifier=
Description
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
Learn more about this trial
A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
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