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

• Status: Completed
• Trial end date: 2019-12-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Paliperidone Palmitate; Risperidone

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