EUCTR2004-000913-21-HU进行中（未招募）不适用
A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching any Antipsychotic Treatment to Sustained-release Quetiapine Fumarate (SEROQUEL) in Patients with Schizophrenia
AstraZeneca R&D Södertälje0 个研究点目标入组 500 人开始时间: 2004年9月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- •For inclusion in the study patients must fulfill all of the following criteria:
- •1. Provision of written informed consent. Only patient deemed fully capable are allowed to be enrolled to the study. Inclusion in the genetic part of the study is under provision of a written informed consent separate from the main study.
- •2.Female and male age more than or equal to 18 and less than or equal to 65 years
- •3.Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for any of the following:
- •SchizophreniaDSM-IV
- •catatonic295.20
- •disorganised295.10
- •paranoid295.30
- •undifferentiated295.90
- •4.Patients who in their own and/or in the Investigator’s opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability.
- •5.Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
- •6.Be able to understand and comply with the requirements of the study, as judged by the Investigator.
- •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
- •1.Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation.
- •2.Substance abuse or dependence as defined by DSM-IV and not in full remission. A urine drug screen test will be performed. The Investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
- •3.Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids as judged by the Investigator.
- •4.Patients who, in the opinion of the Investigator, pose an imminent risk of suicide or a danger to self or others.
- •5.History of non-compliance as judged by the Investigator.
- •6.Evidence of clinically relevant disease, (eg, renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome [AIDS] or cancer) or a clinical finding that is unstable or that, in the opinion of the Investigator, would be negatively affected by the investigational product or that would affect the investigational product
- •7.Clinically significant deviation from the reference range in clinical laboratory test results at enrolment as judged by the Investigator.
- •8.ECG considered to show cardiac abnormality at enrolment as determined by a central reader cardiologist and confirmed by Investigator as clinically significant.
- •9.A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •-unstable DM defined as enrolment glycosylated Hb >8.5%
- •-admitted to hospital for treatment of DM or DM related illness in the past 12 weeks
- •-not under care of physician responsible for patient’s DM care
- •-physician responsible for patient’s DM care has not indicated that patient’s DM is controlled
- •-physician responsible for patient’s DM care has not approved patient’s participation in the study
- •-has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to enrolment (Visit 1). For thiazolidinediones (glitazones) this period should not be less than 8 weeks
- •-taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
- •Note: If a diabetic patient meets one of these criteria the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- •10.A thyroid-stimulating hormone (TSH) concentration higher than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the patient is being treated for hypothyroidism.
- •11.Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before day of switch (Visit 2).
- •12.Known intolerance, or lack of response to treatment with quetiapine IR or treatment with quetiapine IR within 4 weeks prior to enrolment.
- •13.Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrolment.
- •14.Patients who have started treatment within 4 weeks prior to enrolment with potent cytochrome 3A4 inducers or inhibitors that could potentially affect the metabolism of quetiapine (eg, inducers: phenytoin, carbamazepine, pentobarbital, rifampin, rifabutin, glucocorticoids, thioridazine, St. John's Wort. inhibitors: ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, nefa
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