A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
2013年11月25日 更新者：Johnson & Johnson Taiwan Ltd
An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia
The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.
研究概览
详细说明
This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study.
The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal).
The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale.
Participants' safety will also be monitored throughout the study.
研究类型
介入性
注册 (实际的)
353
阶段
- 第四阶段
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 (according to Diagnostic and Statistical Manual of Mental Disorders [Edition 4] criteria)
- Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
- Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- Participants who are capable of and willing to fill out the questionnaire for themselves
- 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 (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
- Participants with allergy or hypersensitivity to risperidone or paliperidone
- Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
- Participants who have been treated with the long acting antipsychotic injection within 28 days
- Participants with significant risk including suicide or aggressive behavior
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 |
|---|---|
|
实验性的：帕潘立酮缓释剂 (ER)
|
Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.
|
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 |
|---|---|---|
|
Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
大体时间：Week 12
|
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.
Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.
|
Week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
大体时间：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
大体时间：Week 12
|
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.
|
Week 12
|
|
Change From Baseline in Personal and Social Performance (PSP) Score at Week 12
大体时间：Baseline, Week 12
|
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function.
Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
|
Baseline, Week 12
|
|
Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
大体时间：Baseline, Week 12
|
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 (SR).
A 'compliant' response is scored as +1; a dysphoric response is scored as -1.
A positive sum of items indicates a positive 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).
|
Baseline, Week 12
|
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5月1日
初级完成 (实际的)
2009年4月1日
研究完成 (实际的)
2009年4月1日
研究注册日期
首次提交
2012年4月12日
首先提交符合 QC 标准的
2012年4月12日
首次发布 (估计)
2012年4月13日
研究记录更新
最后更新发布 (估计)
2014年1月14日
上次提交的符合 QC 标准的更新
2013年11月25日
最后验证
2013年11月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CR015664
- R076477SCH4034 (其他标识符：Johnson & Johnson Taiwan Ltd)
- PAL-TWN-MA2 (其他标识符：Johnson & Johnson Taiwan Ltd)
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.
Paliperidone ER的临床试验
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Medical University of South CarolinaGeorgia State University完全的