Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants (Power)
2014年2月7日 更新者：Janssen Korea, Ltd., Korea
An Open-label, Prospective, Non-Comparative Study to Evaluate Subjective Well-Being and Responses in Patients With Schizophrenia Who Had Switched to Paliperidone Extended-Release Tablets
The purpose of this study is to evaluate improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
研究概览
详细说明
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), and non-comparative study, in participants with schizophrenia.
The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); Acute Treatment phase (24 weeks); Extension phase 1 (24 weeks), which will be followed by additional Extension phase 2 (48 weeks).
Total study duration per participant will be 96 weeks.
Efficacy will primarily be evaluated by change from Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale score and change from Baseline in Drug Attitude Inventory scores.
Participants' safety will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
289
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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Busan、大韩民国
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Changnyeong-Gun、大韩民国
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Chonju、大韩民国
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Chun-An、大韩民国
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Chungcheongbuk-Do、大韩民国
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Dae-Jeon、大韩民国
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Daegu、大韩民国
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Daejeon、大韩民国
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Hwasun Gun、大韩民国
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Iksan、大韩民国
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Kwangjoo、大韩民国
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Naju、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:
- Participants who are diagnosed with schizophrenia (diagnosis criteria: Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV])
- 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-Lack of efficacy, lack of tolerance or lack of compliance
- Participants who are capable of and willing to fill out the questionnaire for themselves
- 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
Exclusion Criteria:
- Participants with the past history of neuroleptic malignant syndrome (NMS), or with allergy or hypersensitivity to risperidone or paliperidone
- Participants who have taken clozapine within one month before screening
- 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)
- Participants with a known or suspected history (for 6 months and longer) of substance dependence according to the DSM-IV criteria
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 Extended-Release (ER) oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.
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Paliperidone ER oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 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 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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Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24
大体时间：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.
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Week 24
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Change From Baseline in Mental Functioning Subscale Score Based on 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.
Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement 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 Self-Control Subscale Score Based on 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.
Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement 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 Emotional Regulation Subscale Score Based on 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.
Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement 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 Physical Functioning Subscale Score Based on 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.
Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement 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.
|
Baseline and Week 24
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Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
大体时间：Baseline and Week 24
|
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.
Social integration subscale score ranges from 0 to 24 and higher score indicates improvement 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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Drug Attitude Inventory (DAI-10) Total Score at Week 24
大体时间：Week 24
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The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants.
It is the binary scale assessing the participant's subjective response.
A 'compliant' response is scored as +1; a dysphoric response is scored as -1.
A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).
The final score is the grand total of the positive and negative points.
Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
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Week 24
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Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24
大体时间：Baseline and Week 24
|
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants.
It is the binary scale assessing the participant's subjective response.
A 'compliant' response is scored as +1; a dysphoric response is scored as -1.
A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).
The final score is the grand total of the positive and negative points.
Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
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 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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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 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 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 that rates how well participants slept.
Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well").
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 that rates how well participants slept.
Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well").
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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12月1日
研究完成 (实际的)
2011年1月1日
研究注册日期
首次提交
2008年10月31日
首先提交符合 QC 标准的
2008年10月31日
首次发布 (估计)
2008年11月2日
研究记录更新
最后更新发布 (估计)
2014年3月27日
上次提交的符合 QC 标准的更新
2014年2月7日
最后验证
2014年2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.