ACTRN12607000639426已完成4 期
europrotective Properties of Quetiapine versus Lithium in a First Episode Mania Cohort: 12-month Neuroanatomical, Neurochemical and Neuro-cognitive Effects and Preliminary Data of Prophylactic Properties
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 25 Years（—）
- 性别
- All
入选标准
- •Meet Diagnostic and Statistical Manual IV Text Revised (DSM-IV TR) diagnosis for mania as part of bipolar I disorder or schizoaffective disorder. Have a Young Mania Rating Scale at baseline of at least 20. Not have had a previous treated manic episode. Have the capacity to provide informed consent to the study and comply with study procedures. Be utilising effective contraception if female, sexually active and of childbearing age. Patients will need to have been on quetiapine and lithium as standard therapy for at least 1 month prior to randomisation.
排除标准
- •Exclusion from the trial includes:
- •-Patients with a known or suspected clinically relevant systemic medical disorder.
- •-Individuals who are pregnant or lactating.
- •-Patients who have had a prior sensitivity or allergy to quetiapine, lithium or their components.
- •-Inability to comply with either the requirements of informed consent or the treatment protocol.
- •-Non-fluency in English.
- •-History of epilepsy.
- •-Clinically relevant biochemical or haematological abnormalities at baseline.
- •-Patients at immediate risk of self harm or risk to others.
- •-Organic mental disease, including mental retardation (Full scale IQ<70).
- •-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 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
- •-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.
- •-An absolute neutrophil count (ANC) of 1.5 x 109 per liter
研究者
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