EUCTR2007-001520-12-PT进行中（未招募）不适用
Efficacy and distinctive effects of atypical antipsychotics on cognitive symptoms in dual diagnosis – A phase IIIb, randomized, open-labelled study to evaluate the cognitive effects of quetiapine XR and olanzapine in patients with schizophrenia and substance abuse
nidade de Investigação em Saúde Mental e Psiquiatria do Centro Hospitalar Conde de Ferreira0 个研究点开始时间: 2007年10月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •For inclusion in the study subjects must fulfil all of the following criteria:
- •1. Provision of written informed consent
- •2. A diagnosis of dual diagnosis (schizophrenia and substance abuse disorder) by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- •3. Males aged 18 through 65 years
- •4. Able to understand and comply with the requirements of the study
- •5. In or outpatients abstinent of non prescribed drugs, like heroine, cocaine, or cannabis, for at least 20 days checked by urinalysis, not taking quetiapine or olanzapine in the last 6 months.
- •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. Any DSM-IV Axis I disorder not defined in the inclusion criteria
- •2. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •3. Known intolerance or lack of response to quetiapine fumarate or to olanzapine, as judged by the investigator
- •4. 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
- •5. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
- •6. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •7. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •8. Unstable or inadequately treated medical illness (e.g. diabetes, congestive heart failure [mandatory since doses are >400mg] angina pectoris, hypertension) as judged by the investigator
- •9. Involvement in the planning and conduct of the study
- •10. Previous enrolment or randomisation of treatment in the present study.
- •11. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- •12. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •Unstable DM defined as enrollment 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 randomization. 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.
- •13. An absolute neutrophil count (ANC) less or equal to 1.5 x 10^9 per liter.
- •14. Abnormal liver function (hepatic enzymes > 3 x the upper normal limit.
研究者
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