ACTRN12610000937011撤回4 期
PREQUEL study- Prevention after ECT with Quetiapine extended release of Lowered Mood (in remitted Major Depressive Disorder following ECT)
St Vincent's Hospital0 个研究点目标入组 40 人开始时间: 2010年11月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •*Provision of written informed consent prior to any study specific procedures
- •*A diagnosis of Major Depressive Disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition, Text-Revision (DSM-IV TR)
- •*Males and females aged 18 to 65 years.
- •*HAMD less than or equal to 7 following a course of ECT which produces remission of depression (HAMD = 7) that is sustained over the last two ECT treatments in the course of ECT, after failure to respond to an adequate trial of at least one antidepressant medication (SSRI or SNRI) or when ECT is the preferred treatment.
- •* Completion of acute course of ECT within 3 weeks of baseline.
- •*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
- •*Able to understand and comply with the requirements of the study.
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study:
- •*Pregnancy or lactation
- •*Any DSM-IV Axis I disorder not defined in the inclusion criteria
- •*Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •*Known intolerance or lack of response to quetiapine fumarate and/or SSRI/SNRI , as judged by the investigator
- •*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
- •*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
- •*Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation/baseline
- •*Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- •*Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- •*Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •*Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension or clinically relevant abnormal laboratory values) as judged by the investigator
- •*Involvement in the planning and conduct of the study
- •*Previous enrolment or randomisation of treatment in the present study.
- •*Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- •*A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •a)Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
- •b)Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- •c)Not under physician care for DM
- •d)Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled.
- •e)Physician responsible for patient’s DM care has not approved patient’s participation in the study
- •f)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.
- •g)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.
- •*An absolute neutrophil count (ANC) of less than or equal to 1.5 x 10 to the 9 per litre
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