EUCTR2009-013028-21-IT进行中（未招募）不适用
SE OF CLINICAL AND INTERMEDIATE PHENOTYPES TO ASSESS RESPONSE TO QUETIAPINE: THE ROLE OF PUTATIVE CAUSATIVE GENES - ND
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE0 个研究点开始时间: 2010年9月10日最近更新:
适应症
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
- •2. Diagnosis of schizophrenia using the Structured Clinical Interview for Diagnosis (SCID) for the Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); 3. Male or female patients aged between 18 and 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 enrollment; 5. Able to understand and comply with the requirements of the study. 6. Patients with a cut off value for PANSS more than 75.
- •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, 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. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization; 8. Patients treated with clozapine within 28 days before the enrolment; 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; 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. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator; 13. Involvement in the planning and conduct of the study; 14. Previous enrollment or randomization of treatment in the present study; 15. Participation in another drug trial within 4 weeks prior to enrollment into this study or longer in accordance with local requirements; 16. A patient with Diabetes Mellitus (DM)
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