JPRN-jRCT2080220515未知3 期
A multicenter, investigative study of the safety and efficacy of extended administration of aripiprazole in combination with mood stabilizer for the treatment of patients with bipolar disorder experiencing a manic or mixed episode
适应症
试验速览
- 阶段
- 3 期
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
- •-Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having 296.4x Bipolar I Disorder in which the most recent episode was manic or 296.6x Bipolar I Disorder in which the most recent episode was mixed
- •-Subjects who were enrolled in and have completed or withdrawn from Study 003 and who meet the following criteria
- •Subjects who show exacerbation of condition or no change in condition:
- •Those subjects who completed Study 003, and whose score for CGI-BP Change from preceding phase (mania) on Day 21 (completion of Study 003) was between 5 (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of condition), or whose score was 4 (No change) (subjects showing no change in condition)
- •Subjects who discontinued due to lack of drug efficacy:
- •Those subjects who discontinued Study 003 between Day 14 and Day 21, for whom the reason of withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse)
排除标准
- 未提供
研究者
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A multicenter investigative study of the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer for the treatment of patients with bipolar disorder experiencing a manic or mixed episodeAcute manic and mixed episodes associated with Bipolar I DisorderJPRN-jRCT2080220516Otsuka Pharmaceutical Co., Ltd.
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