Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.
研究概览
简要总结
There is accumulating experimental evidence to suggest the role of essential fatty acids (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to be dysfunctional on early stages of schizophrenia, according to neurodevelopmental hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular importance at the beginning of the illness. As a relatively safe option, EFA supplementation would be a preferable add on therapy in treating individuals with a first episode of schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up studies of EFA supplementation in FES patients were carried out. The demonstration of the efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would be a strong basis for further studies and prescribing EFAs for a large population of patients who are in the early stages of that debilitating illness.
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
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with schizophrenia using Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
- •Patients aged between 16-35 years
- •Signed informed consent (parallel parents consent for individuals under 18 years of age)
排除标准
- •Patients taking fish oil supplements (a washout period of 6 months is required)
- •Patients diagnosed with epilepsy or suffering from epileptic seizures
- •Patients receiving anticoagulant medication e.g., Warfarin
- •Patients receiving psychotherapy
- •Chronic somatic diseases
- •Psychoactive substance dependence
- •Pregnancy and lactation
- •Mental retardation or diagnosed organic brain injury
结局指标
主要结局
The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.
时间窗: 8 and 26 weeks of supplementation
The Positive and Negative Syndrome Scale \[64\] will be used to assess the efficacy of EPA+DHA supplementation in reducing symptom severity in first-episode schizophrenia after 8 and 26 weeks of supplementation. The main outcome measure will be the change in symptom severity from baseline to week 26. Baseline PANSS total score will be subtracted from PANSS score obtained after 26 weeks, resulting in the degree of change observed in the study.
次要结局
- Calgary Depression Scale for Schizophrenia (CDSS)(Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks)
- Clinical Global Impression (CGI)(Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks)
- PANSS total, positive, negative and general psychopathology subscales(Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks)
- Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse(26 weeks intervention plus 26 weeks observation)
- Niacin Flush Skin Test(Baseline, 8 and 26 weeks)
- Equivalent doses of antipsychotics used(Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks)
- Side effects profile according to self-prepared questionnaire(Baseline, 4, 8, 26)
- Cognitive performance using composite battery of neuropsychologic tests(Baseline, 8 and 26 weeks)
- Global Assessment of Functioning (GAF)(Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks)
- Lymphocyte telomerase activity(Baseline, 8 and 26 weeks)
- A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus(Baseline, 26 weeks)
- Grey matter volume: a voxel based structural MRI assessment(Baseline, 8 and 26 weeks)
研究者
Tomasz Pawelczyk
Assistant Professor
Medical University of Lodz