EUCTR2006-002342-11-DE进行中（未招募）不适用
Multicenter study of neurotransmitters and neuropeptides in schizophrenia: A multidisciplinary study of biological, pharmacokinetic, receptor occupancy and clinical relationships in patients suffering from schizophrenia treated with quetiapine (Seroquel®). - Quetiapine-Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
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. Diagnosis of schizophrenia by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- •Paranoid Type (295.30)
- •Catatonic Type (295.20)
- •Disorganized Type (295.10)
- •Undifferentiated Type (295.90)
- •Residual Type (295.60)
- •2. Females and males aged 18-55 years
- •3. Clinical indication for a new treatment with antipsychotics (in case of an acute phase) or an adaptation or change of antipsychotic medication (due to an instable course)
- •4. PANSS score at entry > 60
- •5. 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
- •6. Written informed consent
- •7. Capability to understand and comply with the requirements of the study
- •8. Patients without any medication affecting (serotonergic, dopaminergic and noradrenergic neurotransmission)
- •9. Patients with antipsychotic and / or antidepressive pre-treatment can be enrolled after a wash out period of 7 days. In case of fluoxetine at least 4 weeks
- •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. Predominantly organic psychosis
- •3. Any medical disease which will be related to psychopathology of the patient or will interfere with treatment requirements
- •4. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- •5. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- •6. Treatment with drugs affecting (serotonergic, dopaminergic and noradrenergic neurotransmission), especially neuroleptics, antidepressants, sedatives
- •7. Patients who had suffered from colzapine-induced agranulocytosis, or who had been treated with clozapine during two months prior to enrolement
- •8. Pregnancy or lactation
- •9. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •10. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- •11. 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
- •12. 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
- •13. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •14. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •15. Unstable or inadequately treated medical illness (e.g. diabetes, 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
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