跳至主要内容
临床试验/EUCTR2004-003781-14-ES
EUCTR2004-003781-14-ES进行中(未招募)1 期

A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of Risperidone Long-Acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar I Disorder, with Open-Label Extension

Johnson and Johnson Pharmaceutical Research and Development, una división de Janssen-Cilag, S.A0 个研究点目标入组 0 人开始时间: 2005年11月3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)
发起方

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

性别
All

入选标准

  • Male or female between theages of 18-65
  • Diagnosis of bipoar I disorder as defined by DSM-IV-TR
  • Currently experienceing a manic or mixed episode or stable
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • History of more that 4 mood episodes each year (rapid cycling)
  • Meets DSM-IV-TR criteria for depressive episode, antisocial or borderline personality disorder
  • Has an unstable serious medical ilness
  • Known or suspected history of substance abuse withing helast 6 months
  • Significant risk of injuring him/herself or others or causing significant damage to property

研究者

发起方
Johnson and Johnson Pharmaceutical Research and Development, una división de Janssen-Cilag, S.A

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