EUCTR2007-005773-63-FI进行中（未招募）不适用
A Pilot Study of Three-Weeks, Randomized, Prospective, Open Comparison in Schizophrenic In-patients Treated with Quetiapine Prolong or Oral Risperidone at Flexible Dose
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
- 30
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 informed, written consent
- •2. Male or female, aged 18 - 65
- •3. In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia, schizoaffective disorder or schizophreniformic psychosis (according to DSM-IV diagnostic criteria).
- •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 enrolment.
- •5. Be able to understand and comply with the requirements of the study.
- •6. PANSS = 65
- •7. CGI = 4
- •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. In-patients/hospitalized > 7 days before enrolment
- •4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •5. Known intolerance or lack of response to quetiapine fumarate or risperidone, as judged by the investigator
- •6. 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
- •7. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
- •8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •9. Treatment with clozapine must have stopped at least 28 days prior to randomisation
- •10. Patients taking antidepressant drugs (SSRIs or SRNIs) or mood stabilizers (lithium or divalproax) must have been on a stable dose at least two weeks prior to enrolment
- •11. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV-criteria
- •12. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- •13. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •14. Unstable or inadequately treated medical illness (eg,. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- •15. Involvement in the planning and conduct of the study
- •16. Previous enrolment or randomisation of treatment in the present study
- •17. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirement
- •18. An absolute neutrophil count (ANC) of = 1,0 x 109 /L
- •19. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •- Unstable DM defined as enrolment 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
- •- Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. 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 if the treating physician believes that the patient is stable and can participate in the study.
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