EUCTR2007-004740-79-FI进行中（未招募）不适用
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 Setting - RECOVER
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
- 643
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 and if date of last dose has been dictated at least 3 months prior to enrolment.
- •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)
- •- 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.
- •- 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
- •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
- 另有 3 项未显示
研究者
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