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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Successful Delivery of Risperidone/PP1M/PP3M for the Duration of the Study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Risperidone 3 mg (Drug)
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.
干预措施: Paliperidone Palmitate 50 mg eq. (Drug)
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.
干预措施: Paliperidone Palmitate 75 mg eq. (Drug)
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.
干预措施: Paliperidone Palmitate 100 mg eq. (Drug)
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.
干预措施: Paliperidone Palmitate 150 mg eq. (Drug)
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.
干预措施: Paliperidone Palmitate 175 mg eq. (Drug)
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.
干预措施: Paliperidone Palmitate 263 mg eq. (Drug)
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.
干预措施: Paliperidone Palmitate 350 mg eq. (Drug)
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.
干预措施: Paliperidone Palmitate 525 mg eq. (Drug)
结局指标
主要结局
Percentage of Participants With Successful Delivery of Risperidone/PP1M/PP3M for the Duration of the Study
时间窗: Up to Week 46
Percentage of participants with successful delivery of risperidone/PP1M/PP3M for the duration of the study will be reported.
Percentage of Participants With Successful Administration of Risperidone/PP1M/PP3M Throughout the Study
时间窗: Up to Week 46
Percentage of participants with successful administration of risperidone/PP1M/PP3M throughout the study will be reported.
Quality of Life as Assessed by World Health Organization Quality of Life Scale Brief Version (WHO QoL-BREF) Total Score
时间窗: Up to Week 46
The WHO QoL-BREF is a 25 item scale used to assess the quality of life. All items are rated on a five-point likert scale using response categories such as 1 represents very poor and 5 represents very well with a possible maximum score of 125 and a minimum score of 25.
Percentage of Participants With Successful Completion of Study Procedures
时间窗: Up to Week 46
Percentage of participants with successful completion of study procedures related to diagnosis and outcome measures assessment will be reported.
Clinician Satisfaction as Assessed by Clinician Satisfaction Rating Scale Score
时间窗: Up to Week 46
The Clinician Satisfaction Rating is a 4-item scale. Two items use a Likert scale with a six-point range from 0 (definitively not) to 6 (definitely) and two items are multiple-choice (example, "select all that apply"). The scale will be used to assess the acceptability and/or burden for the provider associated with the study including treatment with long-acting injectables (LAIs).
次要结局
- Number of Participants Intended to Complete/Attend Next Visit as Assessed by Intent-to-Attend (ITA) Plus Assessment Scale(Up to Week 46)
- Number of Participants With Adverse Events (AEs) as a Measure of Safety(Up to Week 46)
- Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI)-MINI Screen and Module K Criteria(Up to Week 46)
- Indirect Cost Assessment of Schizophrenia Care as Assessed by Cost Assessment Questionnaire (CAQ)(Up to Week 46)
- Psychosis as Assessed by Mental Illness With Lay Evidence (SMILE) Scale Score(Up to Week 46)
- Clinical Global Impression - Severity of Schizophrenia (CGI-SS) Scale Total Score(Up to Week 46)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score(Baseline up to Week 46)
- Direct Cost Assessment of Schizophrenia Care as Assessed by Client Service Receipt Inventory (CSRI) Scale Score(Up to Week 46)