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临床试验/EUCTR2012-003136-23-GB
EUCTR2012-003136-23-GB进行中(未招募)1 期

amotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness - LABILE

Imperial College London0 个研究点目标入组 276 人开始时间: 2012年11月16日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
276

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Inclusion Criteria: - Age 18 and over. - Fulfilling DSM-IV diagnostic criteria for Borderline Personality Disorder. - Competent and willing to provide written, informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Exclusion Criteria: - Currently fulfilling criteria for Bipolar affective disorder (type I & II), or psychotic disorder (schizophrenia, schizoaffective disorder, or mood disorder with psychotic features). - At present receiving a mood stabiliser(s) (e.g lithium, carbamazepine, or valproate)*. - Known medical history of liver or kidney impairment. - Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures. - Any woman who is pregnant or planning a pregnancy, and any woman of child bearing potential unless using adequate contraception. This will be established using structured questioning at screening and follow-up, and documented in the case report form. - Participation in any other clinical trial within the past 4 months. *Participants will be required to discontinue any mood stabiser(s) (e.g. lithium, carbamazepine, or valproate) for at least four weeks before entry into the study.

研究者

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