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临床试验/ISRCTN91624955
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 Currently taking any psychotropic drug that cannot be withdrawn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

发起方
niversity of Oxford (UK)

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