A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia
2013年10月9日 更新者：Janssen-Cilag Turkey
An Open-label, Single-arm, Multicenter, Phase IV Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia
The purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) 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 a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (ER) in participants with schizophrenia.
During the study period, dose of paliperidone ER will remain within the range of 3 to 12 milligram per day and will be administered for 12 months.
Both hospitalized and non-hospitalized participants may be included in the study.
Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done.
Maximum 4 weeks of switching period is allowed.
Use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted.
Response to treatment will be evaluated primarily through total Personal and Social Performance (PSP) Scale.
Participants' safety will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
84
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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Adana、火鸡
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Ankara、火鸡
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Antalya、火鸡
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Bursa、火鸡
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Istanbul、火鸡
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Manisa、火鸡
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Samsun、火鸡
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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:
- Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
- To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
- Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
- Participants who are willing and capable to complete the questionnaires
Exclusion Criteria:
- Use of clozapine, depot neuroleptics or risperidone within the last 3 months
- Any unstable clinical condition including clinically important abnormal laboratory findings
- Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
- History of malignant neuroleptic syndrome
- To be considered carrying high risk regarding adverse effects, homicide and/or suicide
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 extended-release (ER)
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Paliperidone ER tablets will be administered orally once daily as flexible dose ranging from 3 to 12 milligram (mg) per day for 12 months.
The recommended dose will be 6 mg once daily.
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 Total Personal and Social Performance (PSP) Score at Month 12
大体时间：Baseline and Month 12
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The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors).
The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.
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Baseline and Month 12
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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 Global Assessment of Functioning (GAF) Score at Month 12
大体时间：Baseline and Month 12
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The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults.
The higher score range (that is, 91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms.
The lower score range (that is, 1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
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Baseline and Month 12
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Change from Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score and Subscales Score at Month 12
大体时间：Baseline and Month 12
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The PANSS is a scale which measures the severity of psychotic symptoms of schizophrenia.
Score ranges from 30 to 210 where 30=best and 210=worst.
The scale consists of three subscales: positive subscale (Range 7 to 49), negative subscale (Range 7 to 49) and general psychopathology subscale (Range 16 to 112), which measures from absent to extreme condition.
Higher scores indicate worsening.
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Baseline and Month 12
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Change from Baseline in Short Form (SF)-36 Scale Score at Month 12
大体时间：Baseline and Month 12
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The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health.
Each item is scored on a range of 0 to 100.
Worst value is 0 and best value is 100.
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Baseline and Month 12
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Change from Baseline in Percentage of Participants With Relapse at Month 12
大体时间：Baseline and Month 12
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The relapse will be diagnosed if participants meet any of the following criteria on 2 consecutive evaluations conducted 3 to 5 days apart: Psychiatric hospitalization; increase in level of care necessary and 25 percent increase in total PANSS score from Baseline; significant clinical deterioration defined as a clinical global impression of change scale score of 6 (indicating much worse); deliberate self-injury; clinically significant suicidal or homicidal ideation; violent behavior resulting in significant injury to another person or property; exceeding the registered dose of drug.
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Baseline and Month 12
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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。
调查人员
- 研究主任：Janssen-Cilag Turkey Clinical Trial、Janssen-Cilag Turkey
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
2009年5月1日
初级完成 (实际的)
2011年10月1日
研究完成 (实际的)
2011年10月1日
研究注册日期
首次提交
2009年6月5日
首先提交符合 QC 标准的
2009年6月5日
首次发布 (估计)
2009年6月8日
研究记录更新
最后更新发布 (估计)
2013年10月10日
上次提交的符合 QC 标准的更新
2013年10月9日
最后验证
2013年10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.
Paliperidone extended-release (ER)的临床试验
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University of New MexicoNational Center for Complementary and Integrative Health (NCCIH)完全的