EUCTR2005-005839-10-DE进行中（未招募）不适用
Efficacy and safety of quetiapine in treating affective symptoms of patients with first-episode psychosis - a pilot study
Georg-August-University Göttingen0 个研究点目标入组 60 人开始时间: 2006年8月23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
- 60
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
- •·male and female patients with first-episode schizophrenia (based on ICD-10 criteria)
- •·in- and out-patients
- •·age between 18 and 45
- •·verbal IQ ³ 85
- •·given written informed consent
- •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
- •·Other Psychiatric disorders not in full remission, concomitant organic mental disorder or mental retardation
- •·Patients who, in the investigator´s judgement, pose an imminent risk of suicide or a danger to self or others
- •·Hamilton Depression Rating Scale < 7 points
- •·Female patients who are pregnant, lactating or at risk of pregnancy
- •·history of idiopathic orthostatic hypotension, or condition that would predispose to (dehydration, hypovolaemia)
- •·Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B and C, via blood or other body fluids
- •·history of non-compliance as judged by the investigator
- •·Patients with substance dependence. A urine drug screen will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets the DSM-IV criteria for substance dependence
- •·Patients with known diabetes mellitus or impaired glucose tolerance, especially a patient with Diabetes Mellitus (DM), glycosylated hemoglobin (HbA1c)>8.5%
- •·ECG considered to show clinical significant abnormalities at enrolment as determined by a cardiologist
- •·A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range and the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism
- •·Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzyme within 2 weeks prior to randomization (e.g. inducers: phenytoin, carbamazepine, phenobarbital, rifampicin, rifabutin, glucocorticoids, thioridazine and St. Johns´wort (= Johanniskraut) and inhibitors: ketokonazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, fluvoxamine, nefazodone, troleandomycin, indinavir, nelfinavir and saquinavir).
- •·Any serious and unstable somatic illness (e.g. malignant tumor, severe cardiovascular disease, etc.) that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect study medication. If relevant medical findings are obtained during the examination, it is at the physician’s discretion to initiate additional examinations (e.g. lab testing, ECG). If medically indicated examinations have already been carried out, the results should not be older than two weeks at the time of the screening visit. The patient can only participate in the study if all study results are within the normal range or the examiner has determined a deviation as clinically irrelevant. This should be clearly documented in the CRF.
- •·Participation in another drug trial within 4 weeks prior to enrolment into this study or longer in accordance with local requirements
- •·patients with insufficient knowledge of the German language
研究者
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