A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)- Total
研究概览
简要总结
The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
详细描述
Objective
Study the effect of adding Ethyl-EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
Methods and material:
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Design: Multicentre, randomized, double-blind, placebo-controlled, fixed dose, 2x2 factorial, add-on clinical trial.
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Sample:
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Patients with schizophrenia, schizoaffective disorder or schizophreniform disorder (DSM-IV); aged 18-40 years; less than 15 years since first psychotic symptoms;admitted to a psychiatric department within the previous 21 days before screening; speaks fluently a Scandinavian language;treated with antipsychotics; written informed consent;no known allergy to trial agents;no substance dependence (DSM-IV);no warfarin currently or anamnestic indicators of impaired haemostasis. Planned: 200 patients. Actually included: 99 intent-to-treat patients.
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Healthy controls: aged 18-40 years;no mental disorder (DSM-IV). Included: 20 persons.
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Clinical assessments: Positive and Negative Syndrome Scale (PANSS) (main outcome variable). Self-report questionnaire. Adverse effects (UKURS). Neurocognitive assessment battery. Niacin skin flush test. General medical assessment.
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Blood samples: RBC fatty acids, S-α-tocopherol, F2-isoprostane (kits), monocyte mRNA Phospholipase A22 (PLA2) Gr4a and 6a (RT-PCR method), RBC Gr4a PLA2 concentration (ELISA technique), a range of other biochemical tests.
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Experimental treatment over 16 weeks: Ethyl-EPA 2 g/d or Placebo EPA and Vitamin E 364 mg/d + Vitamin C 1000 mg/d or Placebo Antioxidants
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Statistics: Linear Mixed Model for longitudinal analyses of effects; other uni- and multivariate methods (SPSS 12.0 - PASW Statistics 18).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with schizophrenia, schizophreniform disorder or schizoaffective disorder (DSM-IV)
- •Admitted to a psychiatric hospital/department within the previous twenty-one days before screening
- •Less than fifteen years, in retrospect, since first psychotic symptoms (DSM-IV 295, criteria A,1-4)
- •Age 18-40 years
- •Speaks fluently a Scandinavian language
- •A written informed consent must be obtained before any trial-related activities
排除标准
- •A diagnosis of substance dependence (DSM-IV)
- •Known allergy to study medication
- •Currently taking warfarin or having anamnestic indicators of impaired haemostasis (profuse bleeding, except epistaxis)
研究组 & 干预措施
Ethyl EPA (active) and Vitamins E + C (active)
干预措施: Ethyl-eicosapentaenoic acid (EPA) (Drug)
Ethyl EPA (active) and Vitamins E + C (active)
干预措施: Vitamins E + C (Drug)
Ethyl EPA (active) and Vitamins E+C (placebo)
干预措施: Ethyl-eicosapentaenoic acid (EPA) (Drug)
Ethyl EPA (active) and Vitamins E+C (placebo)
干预措施: Vitamins E+C (placebo) (Other)
Ethyl EPA (placebo) and Vitamins E+C (active)
干预措施: Vitamins E + C (Drug)
Ethyl EPA (placebo) and Vitamins E+C (active)
干预措施: Etyl EPA (placebo) (Other)
Ethyl EPA (placebo) and Vitamins E+C (placebo)
干预措施: Vitamins E+C (placebo) (Other)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)- Total
时间窗: Baseline - 8 weeks - 16 weeks
次要结局
- Free thyroxin (T4)(Weeks 0, 16)
- Potassium(Weeks 0, 16)
- Ferritin(Weeks 0,16)
- Body Mass Index(Weeks 0, 16)
- PANSS Subscales Negative, Positive, General Psychopathology(Weeks 0, 8, 16)
- GLOBAL ASSESSMENT OF FUNCTIONING- Split Version (S-GAF)(Weeks 0, 8, 16)
- WONCA-COOP FUNCTIONAL HEALTH ASSESSMENT CHARTS(Weeks 0, 8, 16)
- NIACIN SKIN FLUSH TEST(Weeks 0, 8, 16)
- Haemoglobin(Weeks 0, 16)
- THE UKU SIDE EFFECT RATING SCALE (USERS)(Weeks 0,4,8,12,16)
- SERIOUS ADVERSE EVENTS(Weeks 0,4,8,12,16)
- CONCOMITANT ANTIPSYCHOTIC MEDICATION(Weeks 0,4,8,12,16)
- Kimura Recurring Recognition Figures Test(Weeks 0, 16)
- Hopkins Verbal Learning Test.(Weeks 0, 16)
- Continuous Performance Test(Weeks 0, 16)
- Hopkins Verbal Learning Test(Weeks 0, 16)
- Paced Auditory Serial Addition Test(Weeks 0, 16)
- Stroop Test(Weeks 0, 16)
- Digit Span(Weeks 0, 16)
- The Letter - Number Task(Weeks 0,16)
- Semantic and Category Fluency(Weeks 0, 16)
- Blood pressure - systolic, diastolic(Weeks 0, 16)
- Heart rate(Weeks 0, 16)
- Albumin(Weeks 0, 16)
- Leukocytes(Weeks 0, 16)
- Calcium(Weeks 0, 16)
- Urate(Weeks 0, 16)
- Sodium(Weeks 0, 16)
- Glucose(Weeks 0, 16)
- Cholesterol(Weeks 0, 16)
- Triglycerides(Weeks 0, 16)
- Fatty acids in red blood cells(Weeks 0, 16)
- Alpha-tocopherol adjusted for [triglycerides]+[cholesterol].(Weeks 0, 16)
- Total antioxidant status(Weeks 0, 16)
- Malondialdehyde(Weeks 0, 16)
- F2-isoprostane (8-epiPGF2-alpha)(Weeks 0, 16)
- Cytosolic PLA2 group IV in red blood cells(ELISA method)
- Gene expression of mRNA for Phospholipase A2 (PLA2) groups IVa and VIa in monocytes.(Weeks 0, 16)
- Mean Corpuscular Haemoglobin Concentration (MCHC)(Weeks 0, 16)
- Mean Corpuscular Volume (MCV)(Weeks 0, 16)
- C- Reactive Protein (CRP)(Weeks 0, 16)
- Thyroid Stimulating Hormone (TSH)(Weeks 0, 16)