EUCTR2006-006426-26-SE进行中（未招募）不适用
FAST – A randomised, open-label, parallel, multicentre Phase IIIb Study to evaluate the Efficacy and Safety of Quetiapine IR titrared over 4 Days in Patients with Acute Psychosis (Rapid versus Conventional Titration) - FAST
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 before initiation of any study-related procedure.
- •2. Male or female, aged 18-65 years.
- •3. Requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode of schizophrenia, schizoaffective disorder, psychosis NOS or bipolar mania (according to DSM-IV diagnostic criteria).
- •4. Patients who are able to swallow tablets from Day 1 of the study period and who are expected not to be in need of other antipsychotic medication during the study, 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. In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5.
- •2. Patients with known relevant clinical disease (renal or hepatic impairment; cardiovascular- or cerebrovascular disease; congestive heart failure; diabetes mellitus; history of seizures), or other significant or unstable disease, including malignancy, as judged by the Investigator.
- •3. History of multiple episodes of syncope, or significant orthostatic hypotension, as judged by the Investigator.
- •4. Patients with known neutropenia. Patients with an absolute neutrophil count (ANC) of less or equal to 1.5 x 10 9/L will be excluded from the study. Patients with fever at enrolment must not be included in the study if no ANC result is available.
- •5. Treatment with clozapine within 28 Days prior to enrolment in this study.
- •6. Administration of Cytochrome P450 inducers or Cytochrome P450 inhibitors in the 14 Days preceding enrolment into the study, or concomitant use during the study, including, but not limited to, the following:
- •- Cytochrome P450 inducers: phenytoin, carbamazepine, barbiturates, rifampin, St John’s Wort and glucocorticoids
- •- Cytochrome P450 inhibitors: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nalfinavir, ritonavir, fluvoxamine, saquinavir and grape fruit juice
- •7. Known intolerance or lack of response to quetiapine, as judged by the Investigator.
- •8. Pregnancy or lactation. Females of childbearing potential must use a reliable method of contraception i.e. hormonal contraceptives, double-barrier methods, intra-uterine device or tubal ligation, unless their sexual partner is sterile (vasectomy).
- •9. Patients who pose an imminent risk of suicide, or danger to self or others, as judged by the Investigator.
- •10. Acute intoxication due to alcohol or drug dependence at enrolment.
- •11. Involvement in the planning and conduct of this study (applies to both AstraZeneca staff or staff at the study site)
- •12. Previous enrolment or randomisation in the present study.
- •13. Participation in a clinical study of any investigational drug 30 days prior to enrolment and during the study.
研究者
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