ISRCTN91624955已完成4 期
OxLith: exploration of the short-term physical and psychological effects of lithium in mood instability
niversity of Oxford (UK)0 个研究点目标入组 40 人开始时间: 2015年1月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26936776 protocol
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing and able to give informed consent to participate in the trial
- •2. Meeting criteria for bipolar disorder
- •3. Clinical complaint of significant mood instability
- •4. Clinical uncertainty about the prescription of lithium
- •5. No clear indication for alternative treatment
- •6. Pre-treatment blood test results acceptable for initiation of lithium
- •7. Willing and able to comply with all trial requirements (assessed by a psychiatrist)
- •8. Willing to allow his or her General Practitioner and, if appropriate, psychiatrist to be notified of participation in the trial
排除标准
- •1. Any contraindication to lithium
- •2. Currently taking any psychotropic drug that cannot be withdrawn
- •3. Clinically significant alcohol or substance use
- •4. Requiring immediate treatment for an acute mood episode such that placebo would be inappropriate
- •5. Female and pregnant, lactating or currently planning a pregnancy
- •6. Female of child-bearing potential not willing to use effective contraception
- •7. Participation in another research trial involving an investigational medicinal product in the past 12 weeks
- •8. Judged to be at significant immediate risk of suicide/self-harm
- •(Participants with contraindication to one or both brain scans will be excluded from that part of the trial)
研究者
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