Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia
A Single-dose, Placebo-controlled, Stratified, Randomized, Double-blind, Crossover to Study Pharmacodynamic Effects of AQW051 Followed by a 4-week Multiple-dose Safety and Tolerability in People With Chronic Stable Schizophrenia.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90073
- West LA VA Healthcare Center (UCLA)
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Illinois
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Chicago、Illinois、美国、60611
- Department of Psychiatry & Behavioural Sciences, Feinberg School of Medicine (Northwestern University)
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Maryland
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Baltimore、Maryland、美国、21228
- Maryland Psychiatric Research Centre, Spring Grove Hospital Grounds
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Massachusetts
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Boston、Massachusetts、美国、02115
- Massachusetts General Hospital (Freedom Trail Clinic)
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University
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New York
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New York、New York、美国、10032
- Columbia University
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North Carolina
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Butner、North Carolina、美国、27509
- JUH Clinical Research (Duke University),
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV/DSM IV TR)
- Subjects will be currently treated with the stable regimen of one or more of the following second generation antipsychotics: olanzapine, risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
Subjects will meet the following symptom criteria:
- Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item scores less than or equal to 5
- BPRS Conceptual Disorganization item score less than or equal to 4
- Simpson-Angus Scale (SAS) total score less than or equal to 6
- Calgary Depression Scale (CDS) total score less than or equal to 10
Subjects will meet the following cognitive performance criteria:
- Maximum performance level: Performance below 1.0 SD from perfect performance on the Hopkins Verbal Learning Test (HVLT) total (31 or less),
- Minimum performance level: subject must be able to validly complete the fMRI cognitive paradigms
- WTAR: 5th grade reading level assessment
- Subjects must be symptomatically stable and not suffer from an acute exacerbation of their psychosis
Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion. Pregnancy tests are required of all female subjects regardless of reported sterilization.
When performed at screening and practice visit, the result of this test must be received before the subject may be dosed.
- Male subjects must be using two acceptable methods of contraception, (e.g., spermicidal gel plus condom) for the entire duration of the studyuntil the Study Completion visit.
- Subject must have sufficiently stable overall health, as determined by the Investigator. The regular intake of concomitant drugs will be allowed, if the patient is on stable treatment for at least 3 months prior to study enrollment and the concomitant drug does not belong to the list of medication that are not allowed according to Appendix 3. If the patient takes more than one concomitant medication, it is at the Investigator's discretion to decide about the patient's eligibility, depending on the nature of the concomitant medications and the patient's overall health.
Exclusion criteria:
- Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine
- Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system
- Subjects with a DSM-IV diagnosis of substance abuse (other than nicotine) within the last month.
Subjects with a history of significant head injury/trauma, as defined by:
- Loss of consciousness (LOC) for more than 1 hour
- Recurring seizures resulting from the head injury
- Clear cognitive sequelae of the injury
- Cognitive rehabilitation following the injury
- Subjects with a medical or neurological disorder or treatment for such disorder that could interfere with the study medication of the assessment of the subject
- Use of certain concomitant medication
No grapefruit or grapefruit juice is to be consumed for 14 days prior to dosing until 7 days following the last dose.
Other protocol-defined inclusion/exclusion criteria may apply
学习计划
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:交叉作业
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Part 1: Assess BOLD response in key brain areas in schizophrenia patients during the performance of tasks as measured by (fMRI) in people with schizophrenia.
大体时间:2 years (Part 1: 1 year)
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2 years (Part 1: 1 year)
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Part 2: Assess safety and tolerability of multiple doses of AQW051 schizophrenia patients.
大体时间:Part 2: 8 months
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Part 2: 8 months
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次要结果测量
结果测量 |
大体时间 |
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Measure: To assess the effects of a single dose of AQW051 on performance of working and episodic memory tasks in people with schizophrenia. (Part 1)
大体时间:Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
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Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
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Measure: To determine the relationship of exposure to brain activation after a single dose of AQW051 in people with schizophrenia. (Part 1)
大体时间:2 years (Part 1: 1 year; Part 2: 8 months)
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2 years (Part 1: 1 year; Part 2: 8 months)
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Measure: To determine the dose-exposure response relationship of multiple doses of AQW051 in people with schizophrenia. (Part 2)
大体时间:2 years (Part 1: 1 year; Part 2: 8 months)
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2 years (Part 1: 1 year; Part 2: 8 months)
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Measure: To explore effects of multiple doses of AQW051 on measures of cognition in people with schizophrenia. (Part 2)
大体时间:2 years (Part 1: 1 year; Part 2: 8 months)
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2 years (Part 1: 1 year; Part 2: 8 months)
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的