EUCTR2005-006151-20-DE进行中（未招募）不适用
Quetiapine and the dopaminergic epigenetic control – a pilot study - Quetiapine and Epigenetics
niversity of Erlangen-Nuremberg0 个研究点开始时间: 2006年7月24日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •1.Provision of written informed consent
- •2.A diagnosis of schizophrenia by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- •3.Able to understand and comply with the requirements of the study
- •4.Age: 18 – 65 years
- •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.Any DSM-IV Axis I disorder not defined in the inclusion criteria
- •2.Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •3.Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- •4.Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- •5.Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
- •6.Administration of a depot antipsychotic injection within one dosing interval (for the depot) before inclusion
- •7.Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- •8.Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- •9.Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •10.Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- •11.Involvement in the planning and conduct of the study
- •12.Previous enrolment in the present study.
- •13.Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- •14.Actual treatment with clozapine or clozapine treatment during the previous three month. Other antipsychotic drugs will be allowed, if intake can be terminated during the two day wash out period.
- •15.Previous history of major head injuries or neurological disorders
- •16.Intake of homocysteine lowering vitamins (folate, B12, B6)
- •17.Renal failure
- •18.Intake of nutritional derivatives which influence epigenetic patterns (butyrate from milk products, tea polyphenol or epigallo-catechin-3-gallate which inhibits DNMT)
研究者
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