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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Paliperidone Palmitate 525 mg eq.; Drug: Paliperidone Palmitate 100 mg eq.; Drug: Paliperidone Palmitate 350 mg eq.; Drug: Paliperidone Palmitate 263 mg eq.; Drug: Paliperidone Palmitate 175 mg eq.; Drug: Risperidone 3 mg; Drug: Paliperidone Palmitate 150 mg eq.; Drug: Paliperidone Palmitate 50 mg eq.; Drug: Paliperidone Palmitate 75 mg eq.

Study type: Interventional

Funder types: Industry

Identifiers

NCT03713658

R092670PSY4001 (Other Identifier)

CR108551

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Oral Risperidone

Experimental group

Description:

Participants will receive 3 milligram (mg) oral risperidone tablets once daily for up to one Week to determine tolerability based on investigator review.

Treatment:

Drug: Risperidone 3 mg

Paliperidone Palmitate Once Monthly (PP1M)

Experimental group

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.

Treatment:

Drug: Paliperidone Palmitate 75 mg eq.

Drug: Paliperidone Palmitate 150 mg eq.

Drug: Paliperidone Palmitate 50 mg eq.

Drug: Paliperidone Palmitate 100 mg eq.

Paliperidone Palmitate Every 3 Months (PP3M)

Experimental group

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.

Treatment:

Drug: Paliperidone Palmitate 175 mg eq.

Drug: Paliperidone Palmitate 263 mg eq.

Drug: Paliperidone Palmitate 350 mg eq.

Drug: Paliperidone Palmitate 525 mg eq.