Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants (PASS)
2014年9月3日 更新者：Janssen Korea, Ltd., Korea
An Open-label Prospective, Non-comparative Study to Evaluate the Subjective Experiences Upon Transition to Paliperidone Extended Release(ER) in Subjects With Schizophrenia
The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that is, by the reason to switch: lack of efficacy group, lack of tolerability group, and lack of compliance group) who switched from other previous antipsychotic drugs to paliperidone extended-release tablets at flexible doses.
研究概览
详细说明
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended-release (ER) in participants switching from the previous oral antipsychotic to flexibly dosed paliperidone ER.
The total study duration will be approximately of 24 weeks per participant.
The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (24 weeks).
Efficacy will primarily be evaluated by change from baseline in symptom checklist 90-R (SCL90-R) at Week 24.
Participants' safety will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
387
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Chunchun、大韩民国
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Incheon、大韩民国
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Inchun、大韩民国
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Kangwondo、大韩民国
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Kyunggido、大韩民国
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Kyungki、大韩民国
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Kyunki、大韩民国
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Seoul、大韩民国
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- Participants who are compliant with self-medication or can receive consistent help or support
- Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) Group of lack of efficacy: The antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: The antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: The antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)
Exclusion Criteria:
- Participants with the past history of neuroleptic malignant syndrome (NMS)
- Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
- Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
- Female participants who are pregnant or are breast feeding
- Participants who have participated in any investigational drug trial within 1 month prior to the screening visit
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Paliperidone
Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
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Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
大体时间：Baseline and Week 24
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The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI).
SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely).
Total scale score range from 0 to 360.
Higher scores indicate worsening of disease.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
大体时间：Baseline and Week 24
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The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior.
The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains.
Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
大体时间：Baseline and Week 24
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The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants.
The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF).
The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience).
SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
大体时间：Baseline and Week 24
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Sleep quality was assessed by an 11-point visual analog scale.
Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Scores were averaged for the previous 7 days.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
大体时间：Baseline and Week 24
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Daytime Drowsiness was assessed by an 11-point visual analog scale.
Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Scores were averaged for the previous 7 days.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Krawiecka Scale Score at Week 24
大体时间：Baseline and Week 24
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Psychopathology of participants was assessed by Krawiecka scale.
Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16.
Higher score indicates worsening of disease.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
大体时间：Baseline and Week 24
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The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.
A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants".
Higher scores indicate worsening.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24
大体时间：Baseline and Week 24
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The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年4月1日
初级完成 (实际的)
2010年9月1日
研究完成 (实际的)
2010年10月1日
研究注册日期
首次提交
2008年9月25日
首先提交符合 QC 标准的
2008年9月26日
首次发布 (估计)
2008年9月29日
研究记录更新
最后更新发布 (估计)
2014年9月10日
上次提交的符合 QC 标准的更新
2014年9月3日
最后验证
2014年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.