EUCTR2008-003331-20-DE进行中（未招募）不适用
Effect of quetiapine XR on sleep in patients with major depression, as compared with mirtazapine
Technical University Munich, Klinikum rechts der Isar0 个研究点开始时间: 2008年7月14日最近更新:
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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
- All
入选标准
- •For inclusion in the study patients must fulfil all of the following criteria:
- •1.Provision of written informed consent
- •2.A diagnosis of Major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, revised (DSM-IV-R)
- •3.Females and males aged 18 to 65 years
- •4.Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
- •5.Able to understand and comply with the requirements of the study
- •6.Minimum score in the HAMD-21 scale: 18
- •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
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1.Pregnancy or lactation
- •2.Any DSM-IV-R 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 mirtazapine, 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.Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •8.Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV-R criteria
- •9.Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV-R criteria within 4 weeks prior to enrolment
- •10.Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •11.Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- •12.Involvement in the planning and conduct of the study
- •13.Previous enrolment or randomisation of treatment in the present study.
- •14.Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- •15.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.
- •16.An absolute neutrophil count (ANC) of ? 1.5 x 109 per liter
- •17.Respiratory distress index during the 1st polysomnography > 10
- •18.Periodic leg movement / arousal index during the 1st polysomnography > 10
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