ACTRN12616001702404终止3 期
Efficacy of Lithium versus Lamotrigine for the treatment of bipolar II disorder
Professor Gordon Parker0 个研究点目标入组 44 人开始时间: 2016年12月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
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 65 Years（—）
- 性别
- All
入选标准
- •The general inclusion criteria are that the patient is/has:
- •1. Aged 18-65
- •2. Having a first-onset or new onset of bipolar II disorder as per DSM-5 criteria
- •3. Willing to accept randomised assignment to one of the two treatment options
- •4. Willing to remain on all current medication at the same doses until the trial is ceased or if the managing clinician judges that such medications are unwarranted or have become contra-indicated
- •5. If any rescue drugs or new medications are introduced during the study, these, and reasons for their introduction will be recorded.
排除标准
- •Exclusion criteria are the following:
- •1. Previously trialled LTG or Li
- •2. History of psychotic symptoms
- •3. Pregnancy or breast feeding (The assessing clinician will take responsibility for asking all women where appropriate if they are pregnant or possibly pregnant and if there is any doubt, a pregnancy test will be undertaken [with the patient’s consent]. All patients will be told to inform the clinician if they become pregnant during the study).
- •4. A medical condition which contraindicates one of the treatment groups (for instance, significant renal or cardiovascular disease)
- •5. Acutely suicidality
- •6. A substantive contributory or associated medical/alcohol/illicit drug condition or severe other co-morbid psychiatric condition
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