Clinical trial NCT04940039: A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Official title: Clinical Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Long-acting injectable antipsychotics
Low income countries
schizophrenia
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 93
Sex: ALL
Minimum age (years): 19
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the long-term symptomatic response (Visit 2 \[Week 1\] to Visit 14/Week 66 \[End of Study {EOS}\]) measured by change in the Clinical Global Impressions -Severity for Schizophrenia (CGI-SS) in participants with schizophrenia who are treated in Rwandan real-world healthcare settings with the antipsychotic regimen that starts with oral anti-psychotic (AP) formulation followed by continued treatment with (paliperidone palmitate 1-month \[PP1M\] and 3-month \[PP3M\] formulations).


Eligibility criteria: Inclusion Criteria:

* 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, efficacy, or adherence limitations of current treatment
* Eligible for treatment in the Rwandan mental healthcare system
* At least moderately ill as measured by the Clinical Global Impression - Severity of Schizophrenia (CGI-SS) scale for schizophrenia (rating of greater than or equal to \[\>=\] 4). This criterion needs to be re-confirmed at Visit 2
* Has a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition, provide economic/cost of care information, and is expected to be with the participant for greater than \[\>\] 24 hours each week for the duration of the study)
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) during screening
* Able to give consent to participate in a clinical study that includes treatment with risperidone and long-acting injectable (LAI) formulations of paliperidone palmitate. Participants must be willing to receive injections. The participant and the caregiver must sign their own 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

Exclusion Criteria:

* Has 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
* 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
* Known allergies, hypersensitivity, or intolerance to risperidone or paliperidone palmitate or its excipients
* Received an investigational intervention including investigational vaccines or used an invasive investigational medical device within 30 days before the planned first dose of study intervention, or is currently enrolled in an investigational study
* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study intervention
* Poor prior response to risperidone or paliperidone

Primary outcomes:
measure: Mean Change in Clinical Global Impression Severity of Schizophrenia (CGI-SS) Score from Visit 2 (Week 1) to Visit 14 (Week 66 [End of Study {EOS}])
timeFrame: Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
Secondary outcomes:
measure: Mean Change in CGI-SS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
measure: Mean Change in CGI-SS Score from Visit 2 (Week 1) to Visit 6 (Week 25)
timeFrame: Visit 2 (Week 1) to Visit 6 (Week 25)
measure: Change in Personal and Social Performance (PSP) Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
measure: Change in PSP Scale Scores from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
measure: Change in PSP Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
timeFrame: Visit 2 (Week 1) to Visit 6 (Week 25)
measure: Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
measure: Change in Patient Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
measure: Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
timeFrame: Visit 2 (Week 1) to Visit 6 (Week 25)
measure: Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
measure: Change in Clinician Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
measure: Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)
timeFrame: Visit 2 (Week 1) to Visit 6 (Week 25)
measure: Change in Schizophrenia Quality of Life Scale (SQLS) Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
measure: Change in SQLS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
timeFrame: Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])
measure: Change in SQLS Score from Visit 2 (Week 1) to Visit 6 (Week 25)
timeFrame: Visit 2 (Week 1) to Visit 6 (Week 25)
measure: Number of Participants with Treatment-emergent Adverse Events
timeFrame: Up to Week 66
measure: Number of Participants with Abnormalities in Clinical Laboratory Measures
timeFrame: Up to Week 66
measure: Number of Participants with Abnormalities in Vital Signs
timeFrame: Up to Week 66
measure: Number of Participants with Abnormalities in Electrocardiogram (ECG)
timeFrame: Up to Week 66
measure: Number of Participants with Abnormalities in Physical Examination
timeFrame: Up to Week 66
measure: Number of Participants With Pregnancy Outcome as a Safety Measure
timeFrame: Up to Week 66
measure: Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Visit 12 (Week 46) to Visit 14 (Week 66 [EOS])
Other outcomes:
Locations:
city: Butare
country: Rwanda
facility: University Teaching Hospital of Butare(CHUB)
city: Kibuye
country: Rwanda
facility: Kibuye Referral Hospital
city: Kigali
country: Rwanda
facility: CARAES Ndera Neuro-Psychiatric Hospital
city: Kigali
country: Rwanda
facility: University Teaching Hospital of Kigali
city: Rwamagana
country: Rwanda
facility: Rwamagana Provincial Hospital
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: