EUCTR2008-000041-60-DE进行中（未招募）不适用
Quetiapine in the treatment of psychotic depression. A pilot study(QTP-Dep-Bo) - (QTP-Dep-Bo)
WL Universitätsklinik für Psychiatrie Bochum0 个研究点开始时间: 2008年3月19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
- All
入选标准
- •1.Provision of written informed consent
- •2.A diagnosis of depression with psychotic features by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV 296.23;296.33/ICD-10 F31.5, F32.3, F33.3)
- •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 choriogonadotropine (HCG) test at enrollment.
- •5.Able to understand and comply with the requirements of the study
- •6.MADRS score above 20 points
- •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 or not in full remission (e.g. schizophrenia, bipolar disorder, intoxication)
- •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, as judged by the investigator
- •5.Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment 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 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
- •7.Thyroid-stimulating hormone (TSH) concentration more than 10 % above the upper limit of the normal range and the laboratory used for sample analysis at enrollment, whether or not the patient is being treated for hyperthyroidism
- •8.Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •9.Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria. A urine screen will be performed and the investigator will evaluate the results along with the medical history to find out if the patient meets the DSM-IV criteria for substance dependence.
- •10.Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
- •11.Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •12.Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B via blood or other body fluids
- •13.Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- •14.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.
- •15.An absolute neutrophil count (ANC) ? 1.5 x 109 per liter
- •16.History of idiopathic orthostatic hypotension, or condition that would predispose to (dehydration, hypovolaemia)
- •17.ECG considered to show clinical significant abnormalities at enrollment as determined by a cardiologist
- •18.Involvement in the planning and conduct of the study
- •19.Previous enrollment or randomisation of treatment in the present study.
研究者
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