EUCTR2010-023369-23-DE进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- •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),
- •– surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
- •– 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 at least 3 months after the last intake of study drug.
- •9. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving the study drug.
- •10. Must be able and willing to describe subjective experiences while receiving JNJ-40411813.
- •11. Subjects themselves or the relatives they are living with have to be reachable by phone on a regular basis.
- •12. Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- •13. Must have agreed to frequent blood sampling during the course of the study.
- •14. 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. Subjects who are not capable of understanding the ICF and not competent to give informed consent will not be eligible for this study.
- •Inclusion criteria specific to Acute Subjects (Part A, JNJ-40411813
- •monotherapy)
- •15.Subjects preferring treatment with an antipsychotic with a novel mode-of-action over currently available antipsychotics. Subjects should not have received any oral antipsychotic for at least 5 days or at least 5 half-lives of the antipsychotic used before, if these 5 half-lives are longer than 5 days, and no long acting injectable antipsychotic for at least 3 months, before Day 1. Antipsychotic me
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
- •11. Significant risk of suicidal or violent behavior
- •12. Female subjects who are pregnant or breastfeeding
- •13. Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable. Values of ALT/AST <2 fold the upper limit of normal will be allowed
- •14. Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV antibodies at screening
- •15. Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable.
- •16. 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)
- •17. Use of monoamine oxidase inhibitors within 4 weeks or fluoxetine within 5 weeks before screening. Use of all tricyclic antidepressants within 2 weeks before screening
- •18. Use of mood stabilizers (e.g., anticonvulsants and/or lithium) within 2 weeks before Day 1.
- •19. Received electroconvulsive therapy within 3 months before screening
- •20.Have been involuntarily committed to psychiatric hospitalization or administered to jail/forensic psychiatry by governmental or judicial decree
- •21. Alcohol dependence and/or illicit drug use
- •22. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
- •23. 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
- •24. Employees of the investigator or study center, with direct
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