A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
NCT ID: NCT03713658
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
34 participants
INTERVENTIONAL
2018-10-18
2019-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Oral Risperidone
Participants will receive 3 milligram (mg) oral risperidone tablets once daily for up to one Week to determine tolerability based on investigator review.
Risperidone 3 mg
Participants will receive 3 mg oral risperidone tablets once daily for up to one Week.
Paliperidone Palmitate Once Monthly (PP1M)
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.
Paliperidone Palmitate 50 mg eq.
Participants will receive 50 mg eq. PP1M intramuscular injection for 17 Weeks.
Paliperidone Palmitate 75 mg eq.
Participants will receive 75 mg eq. PP1M intramuscular injection for 17 Weeks.
Paliperidone Palmitate 100 mg eq.
Participants will receive 100 mg eq. PP1M intramuscular injection for 17 Weeks.
Paliperidone Palmitate 150 mg eq.
Participants will receive 150 mg eq. PP1M intramuscular injection for 17 Weeks.
Paliperidone Palmitate Every 3 Months (PP3M)
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.
Paliperidone Palmitate 175 mg eq.
Participants will receive 175 mg eq. PP3M intramuscular injection for 24 Weeks.
Paliperidone Palmitate 263 mg eq.
Participants will receive 263 mg eq. PP3M intramuscular injection for 24 Weeks.
Paliperidone Palmitate 350 mg eq.
Participants will receive 350 mg eq. PP3M intramuscular injection for 24 Weeks.
Paliperidone Palmitate 525 mg eq.
Participants will receive 525 mg eq. PP3M intramuscular injection for 24 Weeks.
Interventions
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Risperidone 3 mg
Participants will receive 3 mg oral risperidone tablets once daily for up to one Week.
Paliperidone Palmitate 50 mg eq.
Participants will receive 50 mg eq. PP1M intramuscular injection for 17 Weeks.
Paliperidone Palmitate 75 mg eq.
Participants will receive 75 mg eq. PP1M intramuscular injection for 17 Weeks.
Paliperidone Palmitate 100 mg eq.
Participants will receive 100 mg eq. PP1M intramuscular injection for 17 Weeks.
Paliperidone Palmitate 150 mg eq.
Participants will receive 150 mg eq. PP1M intramuscular injection for 17 Weeks.
Paliperidone Palmitate 175 mg eq.
Participants will receive 175 mg eq. PP3M intramuscular injection for 24 Weeks.
Paliperidone Palmitate 263 mg eq.
Participants will receive 263 mg eq. PP3M intramuscular injection for 24 Weeks.
Paliperidone Palmitate 350 mg eq.
Participants will receive 350 mg eq. PP3M intramuscular injection for 24 Weeks.
Paliperidone Palmitate 525 mg eq.
Participants will receive 525 mg eq. PP3M intramuscular injection for 24 Weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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CARAES Ndera Neuro-Psychiatric Hospital
Kigali, , Rwanda
Ruhengeri Referral Hospital, Public Hospital
Musanze District, , Rwanda
Kibungo Referral Hospital
Ngoma District, , Rwanda
Countries
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References
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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.
Related Links
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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
Other Identifiers
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R092670PSY4001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108551
Identifier Type: -
Identifier Source: org_study_id
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