EUCTR2006-003519-33-GB进行中（未招募）1 期
RAPID - An Open-Label, Randomised, Multicentre Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immedicate Release), over 14 days, in Acute Schizophrenia / Schizoaffective Disorder (Rapid versus Covential Titration). - RAPID
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
- 234
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
入选标准
- •For inclusion in the study treatment phase, subjects must fulfil all of the following criteria:
- •1.Provision of informed, written consent (or relative or carer assent, if the subject has been assessed as not capable of providing informed, written consent).
- •2.Male or female, aged 18-65 years.
- •3.In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia or schizoaffective disorder (according to DSM-IV diagnostic criteria).
- •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
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1.In-patients who, it is anticipated, will be discharged before the end of the titration period (Day 4).
- •2.Subjects who are considered to be treatment resistant to antipsychotic medication, according to the Kane criteria (Kane et al 1988) (i.e. lack of significant symptom relief after two standard antipsychotic medications, from different classes, after 6 weeks of treatment with a dose equivalent to chlorpromazine 1000 mg per day).
- •3.Subjects with relevant clinical disease (renal or hepatic impairment; cardiovascular disease or cerebrovascular disease; diabetes mellitus or risk factors for the development of diabetes mellitus; history of seizures), or other significant or unstable disease, including malignancy, as judged by the Investigator.
- •4.History of multiple episodes of syncope, or significant orthostatic hypotension, as judged by the Investigator.
- •5.Clinically abnormal ECG at Visit 1 as determined by the Investigator.
- •6.An absolute neutrophil count (ANC) of =1.5 x 109 per liter at Visit 1.
- •7.Administration of concomitant antipsychotic medication during the study including, but not limited to, the following:
- •·Atypical antipsychotics: amisulpride, aripiprazole, clozapine, olanzapine, risperidone and zotepine
- •·Typical antipsychotics: chlorpromazine, fluperitixol, fluphenazine, haloperidol, levomepromazine, pericyazine, perphenazine, pimozide, pipotiazine, prochlorperazine, sulpiride, trifluoperazine, and zucloperithixol.
- •NB: The dosing cycle for depot medication must have completed, and treatment with clozapine must have stopped at least 28 days previously, in order for a subject to be enrolled.
- •8.Administration of hepatic enzyme inducers / inhibitors in the 14 days preceding enrolment into the study, or concomitant use during the study, including 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 and saquinavir
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