FIRST-IN-PATIENT STUDY TO ASSESS THE SAFETY AND TOLERABILITY AND TO EXPLORE THE POTENTIAL THERAPEUTIC EFFICACY OF A NOVEL GLUTAMATE MODULATOR AS MONOTHERAPY AND AS ADD-ON THERAPY IN PATIENTS WITH SCHIZOPHRENIA - N/A

Janssen-Cilag International NV0 个研究点目标入组 105 人2010年12月13日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Janssen-Cilag International NV
入组人数: 105
状态: 进行中（未招募）
最后更新: 12年前

概览研究者入排标准结局指标相似试验

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简要总结

暂无简介。

注册库

who.int

开始日期

2010年12月13日

结束日期

待定

最后更新

12年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Janssen-Cilag International NV

入排标准

入选标准

•1\. Male or female between 18 and 65 years of age, inclusive
•2\. Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI \=
•weight/height2\)
•3\. Medically stable on the basis of physical examination, medical history, vital signs and 12\-lead ECG performed at screening.
•4\. Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to not be clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
•5\. In\- or outpatients who have been diagnosed with schizophrenia according to DSM\-IV (295\.10, 295\.20, 295\.30, 295\.60, 295\.90\) at least 1 year prior to screening.
•6\. Known by the recruiting or referring psychiatrist for at least 12 months.
•7\. Men must agree to use a double barrier method of birth control at each sexual intercourse (at least a condom) and to not donate sperm during the study and for 90 days after receiving the last dose of study drug.
•8\. Women must meet one of the following:
•– postmenopausal (amenorrhoea for at least 12 months prior to screening or amenorrhoea for at least 6 months prior to screening and follicle stimulating hormone \[FSH] concentrations of \>40 mIU/mL),

排除标准

•1\. A current DSM\-IV axis I diagnosis other than schizophrenia
•2\. A DSM\-IV diagnosis of substance abuse or dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary; subjects with a positive drug screen at screening may be included provided use does not lead to a DSM\-IV diagnosis of substance dependence and subjects should be encouraged to abstain from alcohol and illegal drugs within 3 days prior to Day 1 and at any time during the study)
•3\. Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn’s disease, liver disease, or renal disease
•4\. Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases
•5\. PANSS score \<50 or \>120
•6\. Other significant and/or unstable systemic illnesses
•7\. Allergy or hypersensitivity to any known antipsychotic compounds
•8\. Inability to swallow the study medication whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile)
•9\. Subjects who have never been treated with antipsychotics
•10\. Exposure to an experimental drug or experimental medical device within 90 days before screening