Clinical Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 5
- 主要终点
- 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}])
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Risperidone 3 mg (Drug)
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Paliperidone Palmitate 50 mg eq. (Drug)
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Paliperidone Palmitate 75 mg eq. (Drug)
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Paliperidone Palmitate 100 mg eq. (Drug)
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Paliperidone Palmitate 150 mg eq. (Drug)
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Paliperidone Palmitate 175 mg eq. (Drug)
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Paliperidone Palmitate 263 mg eq. (Drug)
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Paliperidone Palmitate 350 mg eq. (Drug)
Paliperidone Palmitate
Participants in Observation Phase will receive their treatment prescribed by treating physicians as part of their routine clinical practice and the standard of care (SoC) treatment for Rwanda mental healthcare settings. Participants who have not received risperidone or paliperidone or paliperidone palmitate earlier in Observation Phase will receive oral risperidone 3 milligram (mg) tablets once daily for 3 days in Run-in Phase to determine tolerability. Participants will receive flexible dose range from 50 to 150 mg equivalent (eq.) long acting formulation of paliperidone palmitate once monthly (PP1M) as an intramuscular (IM) injection in Lead-in Treatment Phase for at least 17 weeks (maximum 25 weeks) and if stable dose is achieved for PP1M, participants will enter Maintenance Treatment Phase and continue to receive flexible dose range from 175 to 525 mg eq. long acting formulation of paliperidone palmitate every 3 months (PP3M) as an IM injection for up to 24 weeks.
干预措施: Paliperidone Palmitate 525 mg eq. (Drug)
结局指标
主要结局
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}])
时间窗: Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])
The CGI-SS will be used to provide a clinical measure of the severity of schizophrenia. It is a single-item Likert scale with a 7-point range (1 indicates none to 7 indicates extreme symptoms).
次要结局
- Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)(Visit 2 (Week 1) to Visit 6 (Week 25))
- Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])(Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]))
- Change in Clinician Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])(Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]))
- Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)(Visit 2 (Week 1) to Visit 6 (Week 25))
- Change in Schizophrenia Quality of Life Scale (SQLS) Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])(Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]))
- Change in SQLS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])(Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]))
- Change in SQLS Score from Visit 2 (Week 1) to Visit 6 (Week 25)(Visit 2 (Week 1) to Visit 6 (Week 25))
- Number of Participants with Treatment-emergent Adverse Events(Up to Week 66)
- Number of Participants with Abnormalities in Clinical Laboratory Measures(Up to Week 66)
- Number of Participants with Abnormalities in Vital Signs(Up to Week 66)
- Number of Participants with Abnormalities in Electrocardiogram (ECG)(Up to Week 66)
- Number of Participants With Pregnancy Outcome as a Safety Measure(Up to Week 66)
- Number of Participants with Abnormalities in Physical Examination(Up to Week 66)
- Mean Change in CGI-SS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])(Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]))
- Mean Change in CGI-SS Score from Visit 2 (Week 1) to Visit 6 (Week 25)(Visit 2 (Week 1) to Visit 6 (Week 25))
- Change in Personal and Social Performance (PSP) Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])(Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]))
- Change in PSP Scale Scores from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])(Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]))
- Change in PSP Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25)(Visit 2 (Week 1) to Visit 6 (Week 25))
- Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS])(Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]))
- Change in Patient Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS])(Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]))
- Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) Score(Visit 12 (Week 46) to Visit 14 (Week 66 [EOS]))