EUCTR2004-000913-21-LV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: 2005年11月22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. Patients who are deemed incapable of providing informed consent may be enrolled if the written informed consent has been obtained from the patients Legally Authorised Representative. 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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