EUCTR2007-007669-20-SK进行中（未招募）1 期
A Double-Blind, Multiple Dose Titration Study to Investigate the Safety,Tolerability and Pharmacokinetics of Once Daily and Twice Daily Doses ofJNJ-37822681 in Male and Female Patients With Stable SchizophreniaProtocol 37822681SCH2003; Phase IIaEudraCT Number: 2007-007669-20JNJ-37822681Amendment INT-1
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium0 个研究点目标入组 36 人开始时间: 2008年5月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must have signed an informed consent document indicating that
- •they understand the purpose of and procedures required for the study and
- •are willing to participate in the study
- •Male or female between 20 and 55 years of age, inclusive
- •Female subjects must meet one of the following:
- •– postmenopauzal (amenorrhoea for at least 12 months and FSH levels
- •of >40 MIU/mL at screening),
- •– surgically sterile, (have had a hysterectomy or bilateral oophorectomy,
- •tubal ligation, or otherwise be incapable of pregnancy)
- •Men participating in this study have to use a condom at each sexual
- •intercourse even when their partner is pregnant. They should not father a
- •child and not donate sperm during the study and for 3 months after
- •receiving the last dose of study drug. For men that have been clinically
- •determined to be vasectomized, this restriction applies for 5 days after
- •receiving the last dose of study drug. Also their female partner should use
- •an effective method of contraception above the condom used by the male
- •study subject. (Effective methods of contraception include prescription
- •oral contraceptives, contraceptive injections, intrauterine device, doublebarrier
- •method, contraceptive patch).
- •In- or outpatients with schizophrenia stably treated for at least 6 months
- •with antipsychotic monotherapy (= 200mg/d chlorpromazine equivalent
- •dose) or stable for at least 3 months without drug therapy; patients who
- •receive a second antipsychotic at doses < recommended for
- •antipsychotic efficacy may participate provided the second antipsychotic
- •will be discontinued at least 2 weeks prior to first dose administration.
- •PANSS at screening < 70
- •DSM-IV criteria for Schizophrenia
- •In the opinion of the investigator and in compliance with local
- •regulations, the subject can be withdrawn from current antipsychotic
- •medication.
- •A known history of schizophrenia of at least 12 months by the referring
- •psychiatrist.
- •Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI =
- •weight/height2)
- •Willing to be hospitalized during the double-blind treatment period of
- •Willing to adhere to the prohibitions and restrictions specified in this
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A DSM-IV axis I diagnosis other than schizophrenia
- •A DSM-IV diagnosis of substance dependence within 6 months prior to
- •screening evaluation (nicotine and caffeine dependence are not
- •exclusionary; patients with a positive drug screen at screening may be
- •included provided use does not lead to a DSM-IV diagnosis of substance
- •dependence and patients consent to abstain from alcohol and illegal
- •drugs within 3 days prior to Day –1 and at any time during the study)
- •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
- •Relevant history of any significant and/or unstable cardiovascular,
- •respiratory, neurologic (including seizures or significant
- •cerebrovascular), renal, hepatic, endocrine, or immunologic diseases
- •History of neuroleptic malignant syndrome (NMS)
- •Other significant and/or unstable systemic illnesses
- •Allergy or hypersensitivity to any known antipsychotic compounds
- •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)
- •Exposure to an experimental drug or experimental medical device within
- •90 days before screening
- •Significant risk of suicidal or violent behavior
- •Female subjects of childbearing potential
- •Female subjects who are pregnant or breastfeeding
- •Alanine aminotransferase or aspartate aminotransferase levels more than
- •2 times the upper limit of normal at screening or baseline
- •Other biochemistry, hematology, or urinalysis results that are not within
- •the laboratory’s reference range, and that are deemed by the investigator
- •to be clinically significant
- •Use of beta-blockers (if used for any indication other than hypertension
- •and still present at baseline)
- •Injection of a depot antipsychotic within 120 days before screening, or
- •use of paliperidone palmitate within 10 months before screening
- •Use of fluoxetine or monoamine oxidase inhibitors within 4 weeks before
- •Use of all other antidepressants, anticonvulsants, or lithium within
- •2 weeks before baseline
- •Received electroconvulsive therapy within 3 months before screening
- •Have been involuntarily committed to psychiatric hospitalization
- •Donation of 1 or more units (approximately 450 mL) of blood or acute
- •loss of an equivalent amount of blood within 90 days prior to study drug
- •administration.
- •Any condition that, in the opinion of the investigator, would compromise
- •the well-being of the subject or the study
- •Employees of the investigator or study center, with direct involvement in
- •the proposed study or other studies under the direction of that investigator
- •or study center, as well as family members of the employees or the
- •investigator.
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