EUCTR2007-004246-32-IT进行中（未招募）不适用
Comparison of Quetiapine Extended-Release (Seroquel XR? ) andRisperidone in the treatment of depressive symptoms, in schizophrenic or schizoaffective patients: A randomized, open label, flexible-dose, parallel group, non inferiority, 12-week study - ND
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
- ASTRAZENECA
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. Male or female patients aged > or equal 18 - < or equal 65 years.
- •3. Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to DSM-IVTR.
- •4. Baseline depressive symptoms, assessed by means of HAM-D (21-item) score > or equal 20, and HAM-D item 1 score > or equal 2.
- •5. Able to understand and comply with the requirements of the study.
- •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 other than schizophrenia and schizoaffective disorder.
- •2. Pregnancy or breast-feeding. Women of childbearing potential must use a reliable contraceptive method.
- •3. Patients with previous intolerance or unresponsiveness to quetiapine or risperidone.
- •4. Patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other AP oral medications during the trial except for the switch period.
- •5. Use of clozapine within 28 days prior to enrolment or clozapine non responders.
- •6. Known previous sensitivity to quetiapine IR or risperidone.
- •7. Any significant clinical disorder that, in the opinion of the investigator, made the
- •subject unsuitable to be given treatment with an investigational drug.
- •8. Serious unstable medical conditions (patients with, renal haemopoietic,
- •endocrinology impairments).
- •9. Patients with unstable or un-adequately treated medical illness e.g. angina pectoris, hypertension, congestive heart failure, as judged by the investigators.
- •10. Liver function tests AST or ALT three times the upper normal limit.
- •11. Pre-existing organic mental disorder.
- •12. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
- •13. Previous enrolment or randomisation of treatments in the present study.
- •14. Participation in a clinical study during the last 30 days.
- •15. An absolute neutrophil count (ANC) of < or equal to 1.5 x 109 per liter.
- •16. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
- •a danger to self or others.
- •17. 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.
- •18. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates,
- •rifampin, St. John?s Wort, and glucocorticoids.
- •19. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •− Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) >8.5%.
- •− Admitted to hospital for treatment of DM or DM related illness in past 12
- •− 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 randomization. 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
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