Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 14
- 主要终点
- Transition rate
研究概览
简要总结
The purpose of this study is to determine whether omega-3 fatty acids are effective in the prevention of psychosis in individuals at ultra-high risk for psychosis.
详细描述
PURPOSE is a randomized double-blind placebo-controlled study. Main objective is to assess the effectivity of omega-3 fatty acid treatment in the prevention of psychosis. The primary outcome measure is the rate of transition to psychosis as determined through CAARMS. Subjects in the age range of 13-20 years with a higher chance of developing psychosis, as determined by the CAARMS, are treated for 6 months with omega-3 fatty acids or placebo. This study in conducted at 14 sites in 9 countries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent of the subject. For individuals younger than 18 years of age the parents / legal representatives need to give consent, and the subject can provide assent (whether the latter is required depends on local laws and regulations).
- •UHR diagnosis as made using the Comprehensive Assessment of At-Risk Mental States (CAARMS) (Yung et al., 2005). Subjects have to meet one or more of the following criteria: (a) attenuated psychotic symptoms, (b) brief limited intermittent psychotic symptoms (a history of one or more episodes of frank psychotic symptoms that resolved spontaneously within 1 week in the past year), or (c) either the presence of schizotypal personality disorder or a family history of psychosis in a first-degree relative, all three together with a recent decline in function.
排除标准
- •Any clinically significant medical condition that may influence the results of the trial or affect the ability to take part in a trial.
- •Laboratory screening values considered clinically relevant by a medical doctor for transaminases, thyroid hormones or coagulation parameters
- •Current or past DSM-IV diagnosis of psychosis, as measured with K-SADS-PL
- •Current treatment with an antipsychotic or mood-stabilising agent
- •Intake of an antipsychotic or mood-stabilising agent in the two weeks prior to study inclusion
- •Intake of an antipsychotic agent equivalent to a total haloperidol use of >50 mg in the six months prior to study inclusion
- •A first-degree relative (i.e. parents, offspring or siblings) participating in this study
- •UHR diagnosis on the basis of attenuated psychotic symptoms that are entirely explained by acute intoxication
- •Current aggression or dangerous behaviour (PANSS G14 score 5 or above)
- •Current suicidality / self-harm (PANSS G6 score 7)
- •Current DSM-IV diagnosis of alcohol or substance dependence as measured with K-SADS-PL
- •Any current or previous neurological disorder, including epilepsy
- •History of head injury resulting in unconsciousness lasting at least 1 hour
- •More than 4 weeks of regular omega-3 supplementation (>2 daily capsules standard strength providing >600 mg combined EPA/DHA) within the last 6 months.
研究组 & 干预措施
Omega-3 fatty acids
Subjects will be treated daily with 1.2 gram omega-3 polyunsaturated fatty acids (720 mg eicosapentaenoic acid (EPA) and 480 mg Docosahexaenoic acid(DHA)) for six months.
干预措施: Omega-3 fatty acids (Drug)
Placebo
Subjects will be treated daily with placebo for six months. Placebo capsules will contain a 1:1 combination of coconut oil and medium chain triglycerides because these do not contain polyunsaturated fatty acids and have no impact on omega-3 fatty acid metabolism. Placebo capsules also contain the same amount of vitamin E as the omega-3 capsules and 1% fish oil to mimic flavour and taste.
干预措施: Placebo (Other)
结局指标
主要结局
Transition rate
时间窗: 2 years
To compare transition rates to psychosis during 2 years of follow-up between the omega-3 fatty acids arm and the placebo arm. Starting point is the first administration of medication at the end of visit 2. Endpoint is the moment that a UHR subject makes a transition to psychosis according to the CAARMS criteria.
次要结局
- Symptomatology(2 years)
- Cognitive function(2 years)
- Tolerability associated with omega-3 fatty acid treatment(2 years)
- Blood levels of (epi)genetic markers(2 years)
- Positive and negative symptoms(2 years)
- Discontinuation rate(2 years)
- Psychosocial functioning(2 years)
- MRI measures(2 years)
- Level of functioning(2 years)
- Clinical Impression(2 years)
- Role functioning(2 years)
- Blood levels of bioactive lipids(2 years)
- Blood levels of immune parameters(2 years)
- Level of depression(2 years)
- Social functioning(2 years)
研究者
Rene Kahn
Prof. dr.
UMC Utrecht