Clinical trial NCT03713658: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Percentage of Participants With Successful Completion of Study Procedures
timeFrame: Up to Week 46
measure: Percentage of Participants With Successful Delivery of Risperidone/PP1M/PP3M for the Duration of the Study
timeFrame: Up to Week 46
measure: Percentage of Participants With Successful Administration of Risperidone/PP1M/PP3M Throughout the Study
timeFrame: Up to Week 46
measure: Quality of Life as Assessed by World Health Organization Quality of Life Scale Brief Version (WHO QoL-BREF) Total Score
timeFrame: Up to Week 46
measure: Clinician Satisfaction as Assessed by Clinician Satisfaction Rating Scale Score
timeFrame: Up to Week 46
Secondary outcomes:
measure: Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI)-MINI Screen and Module K Criteria
timeFrame: Up to Week 46
measure: Number of Participants Intended to Complete/Attend Next Visit as Assessed by Intent-to-Attend (ITA) Plus Assessment Scale
timeFrame: Up to Week 46
measure: Direct Cost Assessment of Schizophrenia Care as Assessed by Client Service Receipt Inventory (CSRI) Scale Score
timeFrame: Up to Week 46
measure: Indirect Cost Assessment of Schizophrenia Care as Assessed by Cost Assessment Questionnaire (CAQ)
timeFrame: Up to Week 46
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline up to Week 46
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety
timeFrame: Up to Week 46
measure: Psychosis as Assessed by Mental Illness With Lay Evidence (SMILE) Scale Score
timeFrame: Up to Week 46
measure: Clinical Global Impression - Severity of Schizophrenia (CGI-SS) Scale Total Score
timeFrame: Up to Week 46
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: CARAES Ndera Neuro-Psychiatric Hospital
city: Musanze District
country: Rwanda
facility: Ruhengeri Referral Hospital, Public Hospital
city: Ngoma District
country: Rwanda
facility: Kibungo Referral Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: