EUCTR2009-011911-19-DE进行中（未招募）不适用
Impact of quetiapine prolong and escitalopram on the hypothalamic-pituitary-adrenocortical (HPA)-axis activity in depressed patients
udwig-Maximilian-University of Munich, Department of Psychiatry0 个研究点开始时间: 2009年4月21日最近更新:
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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
- All
入选标准
- •1.Inpatients (the admission to hospital occurs independently from study participation)
- •2.Provision of written informed consent
- •3.A diagnosis of major depression by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) (unipolar depression: 296.2, 296.3)
- •4.Female and male patients aged 18 to 65 years
- •5.Female patients of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at enrolment and e willing to use a reliable method of birth control (i.e. barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal litigation) during the study.
- •6.Able to understand and comply with the requirements of the study as judged by the investigator.
- •7.A sum score of at least 18 on the 21-item version of the Hamilton Depression Rating Scale (21-HAMD)
- •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.Pregnancy or lactation
- •2.Any DSM-IV Axis I disorder not defined in the inclusion criteria
- •3.Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •4.Known intolerance or lack of response to quetiapine fumarate and/or escitalopram, as judged by the investigator
- •5.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
- •6.Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
- •7.Use of monoamine oxidase inhibitors (MAOIs) or other serotonergic drugs (e.g. triptanes) in the 14 days preceding enrolment
- •8.Use of oral anticoagulants in the 14 days preceding enrolment
- •9.History of bleeding disorders.
- •10.Use of drugs which are mainly metabolized by cytochrome P450 2D6 having a low therapeutic index (e.g. flecainide, propafenone, metoprolole) in the 14 days preceding enrolment
- •11.Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •12.Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- •13.Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- •14.Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •15.Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- •16.Involvement in the planning and conduct of the study
- •17.Previous enrolment or randomisation of treatment in the present study.
- •18.Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- •19.A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
- •Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- •Not under physician care for DM
- •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 hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. 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.
- •20.An absolute neutrophil count (ANC) of <= 1.5 x 10exp9 per liter
- •21.Abnormal laboratory parameters of clinical relevance before enrolment
- •22.Abnormal blood pressure, abnormal electrocardiogram, and/or abnormal electroencephalogram with clinical relevance before enrolment
- •23.Psychotropic drugs within 3 days before and throug
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