EUCTR2021-000862-14-DK进行中（未招募）1 期
Effects of low dose Aspirin in bipolar disorder – a randomized controlled trial (the A-Bipolar RCT)
Copenhagen Affective Disorder research Center (CADIC),0 个研究点目标入组 250 人开始时间: 2021年3月1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
- 入组人数
- 250
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
- •-Bipolar disorder (type 1 or 2), with diagnoses confirmed by SCAN interview.
- •-Age 18-65 years
- •-Speaks and writes Danish at a level equal to mother tongue
- •-Habile (i.e. able to give informed consent)
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •-Chronic kidney disease with GFR 0-10 ml/min
- •-Severe cardiac insufficiency (NYHA IIIb-IV)
- •-History of gastric ulcers, gastro-intestinal bleeding or other pathological bleeding tendency (thrombocytopenia, hemophilia, vitamin K deficiency)
- •-Asthma or other allergic symptoms developed after intake of salicylates, paracetamol or other NSAID or any of the excipients
- •-Patients already on aspirin or other NSAID, anticoagulants or SSRIs.
- •-For fertile females:
- •oReluctance to use effective contraception (IUD or hormonal contraception) during enrollment, including a safety period of one week following last medication day/trial completion
- •oPregnancy; pregnancy ruled out by HCG test before enrollment
- •oBreastfeeding
- •-Planned major surgery during trial period . If a subject has scheduled major surgery (i.e. with bleeding risk), enrollment will be postponed until this is completed
研究者
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