ACTRN12612001067864已完成4 期
A randomised controlled pilot trial to evaluate the efficacy of fluoxetine in maintaining remission in Crohn's disease
niversity of South Australia0 个研究点目标入组 52 人开始时间: 2012年10月5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
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •Patients had to meet ALL of the following criteria:
- •1). Established diagnosis of CD;
- •2). Remission or only mild symptoms of CD (CDAI <150);
- •3). Have flared CD in the last 12 months (as documented by their treating doctor and demonstrated by either raised inflammatory markers, augmented therapy, high CDAI or calprotectin);
- •4). Be on stable dose of all their current CD therapies for 12 weeks;
- •5). Be 18 years old or older;
- •6). Have a sufficient knowledge of English to understand and answer questionnaires.
- •7). Have the ability to consent to the study.
排除标准
- •Exclusion criteria
- •Patients were excluded if they met ANY of the following:
- •1). Have serious uncontrolled mental illness (e.g. schizophrenia) or are alcohol/substance dependant;
- •2). Currently taking antidepressants;
- •3). Currently receiving psychotherapy;
- •4). Currently taking steroids >15mg or equivalent;
- •5). Are allergic to fluoxetine or any component of placebo;
- •6). Are pregnant or breastfeeding;
- •7). Have cognitive impairment.
研究者
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