EUCTR2007-007083-22-EE进行中（未招募）不适用
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-GroupStudy to Evaluate the Efficacy and Safety of 3 Fixed Doses of JNJ-37822681Administered Twice Daily in Subjects With Schizophrenia
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium0 个研究点目标入组 475 人开始时间: 2008年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 475
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
- •· Male and female between 18 and 65 years of age, inclusive
- •· BMI maximum 40 kg/m2, inclusive (BMI = weight/height2)
- •· Subjects must 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.
- •· 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. It is acceptable to have additional signatures if required by local regulations. Subjects who are unable to provide their own consent or who have been involuntarily committed to psychiatric hospitalization are not eligible to enroll in the study.
- •· Subjects must be experiencing an acute exacerbation of less than 6 months duration, with a PANSS total score at screening between 70 and 120 inclusive and at baseline of between 60 and 120 inclusive.
- •· Women must meet one of the following:
- •– postmenopausal (amenorrhoea for at least 12 months and follicle stimulating hormone (FSH) concentrations of >40 MIU/mL at screening),
- •– surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
- •– abstinent (at the discretion of the investigator/per local regulations),
- •– or if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], male partner sterilization) as local regulations permit,
- •before entry, and must agree to continue to use the same method of contraception throughout the study.
- •· Women of childbearing potential must have a negative urine ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and at baseline before receiving the study drug..
- •· Subjects must agree to voluntary hospitalization for a minimum of 14 days.
- •· Subjects must be willing and able to fill out self-administered questionnaires.
- •· Subjects must be able to be compliant with self-administration of medication, or have consistent help/support available.
- •· Subjects themselves, or caregivers or relatives with whom they are living, have to be reachable by phone on a regular basis.
- •· Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- •· To participate in the optional pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study. All subjects should indicate whether or not they want to participate.
- •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 that has been the focus of treatment or cause of disability in the last 6 months. For example, a major depressive episode that required treatment.
- •· 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 urine drug screen at screening may be included provided use does not lead to a DSM-IV diagnosis of substance dependence, and investigators should instruct them to abstain from alcohol and illegal drugs within 3 days prior to Day –1 and at any time during the study).
- •· Any clinically relevant 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, neurological (including seizures) or significant cerebrovascular, renal, hepatic, endocrine, or immunologic diseases.
- •· History of neuroleptic malignant syndrome.
- •· A history of diabetes or currently receiving a glucose lowering agent or treatment for diabetes.
- •· Subjects suffering from glaucoma.
- •· 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).
- •· Patients who have never been treated with antipsychotics.
- •· Previous history of lack of response to antipsychotic therapy, including olanzapine, when acutely psychotic (lack of response is defined as the subject having had [at least twice] a documented medical history of no clinical response, despite adequate doses and durations of treatment, or the inability to tolerate doses in the indicated dosage range).
- •· Previous use of clozapine for the indications of treatment resistance or reduction of suicidal risk.
- •· Exposure to an experimental drug or experimental medical device within 90 days before screening.
- •· Significant risk of suicidal or violent behavior.
- •· Female subjects who are pregnant or breastfeeding.
- •· Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) concentrations more than 2 times the upper limit of normal at screening.
- •· 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.
- •· Clinically significant abnormal observations in Vital Signs. If vital sign values significantly lie outside the normal ranges at screening, agreement with the J&J PRD Safety Physician must be obtained prior to inclusion of the subject.
- •· Clinically significant abnormal observations in ECG defined as:
- •– A confirmed screening visit QTcB interval =470 msec.
- •– A history of additional risk factors for torsades des pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome).
- •– The use of concomitant medications that prolong the QT/QTc interval.
- •· Use of weight loss drugs such as orlistat, sibutramine or rimonabant.
- •· Use of Chantix® (varenicline)
- •· Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening.
- •· Use of monoamine oxidase inhibitors within 4 weeks or fluoxetine within 5 weeks before screening. Use of all other ant
研究者
相似试验
进行中（未招募）
1 期
A 13-week clinical trial which compares the effectiveness and safety of a not yet approved drug called DS-5565 versus placebo and versus an approved drug, in patients with pain related to fibromyalgiaEUCTR2013-005162-20-SIDaiichi Sankyo, Inc.1,198
进行中（未招募）
1 期
A 13-week clinical trial which compares the effectiveness and safety of a not yet approved drug called DS-5565 versus placebo and versus an approved drug, in patients with pain related to fibromyalgiaDS-5565 is being developed for the treatment of pain associated with fibromyalgia (FM).MedDRA version: 19.0Level: PTClassification code 10048439Term: FibromyalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2013-005162-20-PTDaiichi Sankyo, Inc1,198
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-GroupStudy to Evaluate the Efficacy and Safety of 3 Fixed Doses of JNJ-37822681Administered Twice Daily in Subjects With SchizophreniaSchizophreniaEUCTR2007-007083-22-LTJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium475
进行中（未招募）
2 期
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Type 2 Diabetes MellitusMetabolic and Endocrine - DiabetesType 2 Diabetes MellitusACTRN12610000400066ChemoCentryx, Inc.140
未知
3 期
A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate TherapyRheumatoid ArthritisJPRN-jRCT2080222079Eli Lilly Japan K.K.