Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Scale of Prodromal Symptoms (SOPS)
研究概览
简要总结
The primary objective of this study is to determine whether aspirin is effective in alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The investigators further aim to determine whether it may delay or prevent the onset of psychosis in those currently experiencing CHR symptoms. As secondary measures the investigators aim to collect laboratory studies of inflammation markers and genetic samples to determine whether certain genetic profiles correlate with risk for psychosis, or response to aspirin treatment.
详细描述
Patients will be randomly assigned to either active treatment (aspirin) or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19 - 35
- •Must have a SIPS interview
- •CHR subjects must meet at least one of 3 CHR syndromes defined by SIPS
- •Must demonstrate adequate decisional capacity
排除标准
- •Under age of 19
- •Have pre-existing gastrointestinal disease, heart disease
- •Have kidney disease
- •Taking non-steroidal anti-inflammatory medications
- •Hypersensitive to NSAID (non-steroidal anti-inflammatory medications)
- •Have coexisting unstable major medical illness
- •Are pregnant or breastfeeding
- •Consume more than 2 drinks of alcohol per day
- •Have a blood clotting disorder
- •Are taking ACE inhibitors, acetazolamide, anticoagulants, anticonvulsants, beta blockers, diuretics, methotrexate, oral hypoglycemic or uricosuric agents
- •Have a history of substance abuse in past three moths or dependence in past 6 months
研究组 & 干预措施
1000 mg/day aspirin
1000 mg/day aspirin
干预措施: Aspirin (Drug)
sugar pill
sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
Scale of Prodromal Symptoms (SOPS)
时间窗: 12 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
次要结局
未报告次要终点