EUCTR2007-004740-79-ES进行中（未招募）1 期
A One-Year Randomized, Prospective, Parallel, Open Comparison of Subjective Well-being in Schizophrenic Out-patients Treated with Quetiapine XR (SEROQUEL XR™) or Oral Risperidone at Flexible Dose in a Naturalistic SettingEnsayo clínico aleatorizado, prospectivo, paralelo, abierto, de un año de seguimiento sobre el bienestar subjetivo en pacientes ambulatorios con esquizofrenia tratados con Quetiapina XR versus Risperidona oral en dosis flexibles en un entorno naturalístico - RECOVER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 732
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. Patients who are deemed incapable of providing informed consent may be enrolled if written informed consent has been obtained from the patient´s Legally Acceptable Representative in accordance with local regulations
- •2.Male and female out-patients aged between 18 and 65 years
- •3.Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60, 295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be enrolled
- •4.Patient with first episode of the above mentioned disease (item 3) or patient requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i.e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment
- •5.Female patients of childbearing potential must have a negative urine pregnancy test at enrolment and confirmed by serum pregnancy test and be willing to use a reliable method of birth-control, i.e. double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study, as judged by the investigator
- •6.Be able to understand and comply with the study requirements as judged by the investigator.
- •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.Patients with a baseline SWN-K total score of >75
- •2.Patients with previous treatment with risperidone or quetiapine may be enrolled if change of treatment has not been dictated by major lack of tolerability and efficacy
- •3.Patients taking antidepressant drugs or mood stabilizers who are not on a stable dose since at least 2 weeks prior to enrolment
- •4.Patients with known Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •-Known history of unstable DM defined as 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.
- •-Patients 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.
- •-Patient 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. Upon receipt of visit 1 lab results the investigator will withdraw the patient from the study if HbA1c >8.5%.
- •5.Evidence of clinically relevant disease, eg, renal or hepatic impairment, significant coronary artery disease, congestive heart failure, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS) as judged by the investigator
- •6.Pregnancy or Lactation
- •7.Use of potent cytochrome P450 3A4 inducers (eg barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, rifabutin, thioridazine and St. John’s Wort) in the 14 days preceding randomization
- •8.Use of potent cytochrome P450 3A4 inhibitors (eg macrolide antibiotics [clarithromycin,erythromycin, troleandomycin], azolantifungals [fluconazole, itraconazole, ketoconazole except for topical use], protease inhibitors [indinavir, nelfinavir, ritonavir, saquinavir], fluvoxamine, nefazodone) in the 14 days preceding randomization
- •9.Contraindications as detailed in the country – specific prescribing information for quetiapine XR and risperidone
- •10.Patients with known cardiovascular disease or other conditions predisposing to hypotension or family history of QT prolongation
- •11.Patients at an imminent risk to commit suicide, based on the investigators judgement
- •12.Treatment-resistant patients defined as not responding to optimal dose of 2 successive antipsychotics
- •13.Known history of intolerance or hypersensitivity to quetiapine, risperidone or to any other compound in the tablets
- •14.Administration of a depot antipsychotic medication within one dosing interval prior to randomization
- •15.Involvement in the planning and conduct of the study (applies to both AZ staff or staff at the study site)
- •16.Previous enrolment or randomisation of treatment in the present study
- •17.Participation in another drug trial within 4 weeks prior to enrolment into this study or longer (in accordance with local requirement)
- •18.Possible risk factors for neutropenia including pre-existing low white cells count and history of drug-induced neutropenia (note: upon receipt of visit 1 lab results the in
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