A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
2016年5月2日 更新者：Janssen Research & Development, LLC
A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia
The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.
研究概览
地位
完全的
条件
详细说明
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study.
The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase).
Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29.
Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo.
The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.
研究类型
介入性
注册 (实际的)
509
阶段
- 第三阶段
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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Donetsk、乌克兰
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Evpatoriya、乌克兰
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Glevakha、乌克兰
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Ivano-Frankivsk、乌克兰
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Kerch、乌克兰
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Kharkiv、乌克兰
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Kharkov、乌克兰
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Kherson、乌克兰
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Kiev、乌克兰
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Lviv、乌克兰
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Lvov、乌克兰
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Odesa、乌克兰
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Odessa、乌克兰
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Poltava、乌克兰
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Smela、乌克兰
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Ternopil、乌克兰
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Uzhgorod、乌克兰
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Vinnitsa、乌克兰
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Barranquilla、哥伦比亚
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Bogota、哥伦比亚
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Medellin、哥伦比亚
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Pereira、哥伦比亚
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Guadajalara、墨西哥
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Mexico City、墨西哥
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Monterrey、墨西哥
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San Luis Potosi、墨西哥
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Zapopan、墨西哥
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Deajun、大韩民国
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Gyeongsangnam-Do、大韩民国
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Incheon、大韩民国
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Seongnam、大韩民国
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Diyarbakir、火鸡
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Sakarya、火鸡
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Arad、罗马尼亚
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Craiova、罗马尼亚
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Iasi、罗马尼亚
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Sibiu、罗马尼亚
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Tg Mures、罗马尼亚
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Arkansas
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Little Rock、Arkansas、美国
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California
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San Fran Cisco、California、美国
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District of Columbia
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Washington、District of Columbia、美国
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Florida
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Lauderhill、Florida、美国
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Illinois
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Chicago、Illinois、美国
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Hoffman Estates、Illinois、美国
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Kansas
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Topeka、Kansas、美国
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Maryland
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Baltimore、Maryland、美国
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Mississippi
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Flowood、Mississippi、美国
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New Jersey
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Marlton、New Jersey、美国
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New York
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Cedarhurst、New York、美国
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Oklahoma
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Oklahoma City、Oklahoma、美国
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Texas
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Austin、Texas、美国
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Dallas、Texas、美国
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Utah
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Salt Lake City、Utah、美国
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Johor Bahru、马来西亚
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Kuala Lumpur、马来西亚
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Tanjong Rambutan、马来西亚
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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 70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:
- Patients with schizophrenia for more than 1 year
- A total score in the Positive and Negative Syndrome Scale (PANSS) < 120
- Signed informed consent
- Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
- Men must agree to use a double-barrier method of birth control
- Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
- Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
- A diagnosis of substance dependence within 6 months before screening
- History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
- Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
- Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
- Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
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：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：安慰剂
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Form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
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实验性的：Paliperidone palmitate 3-month (PP3M)
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Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
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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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Time to Relapse During the Double-Blind Phase
大体时间：Approximately Week 60
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Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event.
Median time to relapse was estimated by the Kaplan-Meier method.
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Approximately Week 60
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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 in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
大体时间：Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).
Each item is rated 1 (absent) to 7 (extreme).
The total score ranging from 30 to 210.
Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
大体时间：Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
大体时间：Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior.
The results of the assessment were converted to a numerical score which ranges from 1 to 100.
A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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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。
一般刊物
- Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020.
- Weiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308.
- Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153.
- Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.
- Gopal S, Vermeulen A, Nandy P, Ravenstijn P, Nuamah I, Buron Vidal JA, Berwaerts J, Savitz A, Hough D, Samtani MN. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2015 Nov;31(11):2043-54. doi: 10.1185/03007995.2015.1085849. Epub 2015 Oct 2.
- Berwaerts J, Liu Y, Gopal S, Nuamah I, Xu H, Savitz A, Coppola D, Schotte A, Remmerie B, Maruta N, Hough DW. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):830-9. doi: 10.1001/jamapsychiatry.2015.0241.
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
2012年5月1日
初级完成 (实际的)
2014年4月1日
研究完成 (实际的)
2014年4月1日
研究注册日期
首次提交
2012年2月6日
首先提交符合 QC 标准的
2012年2月8日
首次发布 (估计)
2012年2月9日
研究记录更新
最后更新发布 (估计)
2016年5月11日
上次提交的符合 QC 标准的更新
2016年5月2日
最后验证
2016年5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.