treatment of schizophrenia with an omega-3 fatty acid (epa) and antioxidants

Conditions: Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorder; Psychotic Disorders

Summary: 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.

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: * design: multicentre, randomized, double-blind, placebo-controlled, fixed dose, 2x2 factorial, add-on clinical trial. * sample: * 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. * healthy controls: aged 18-40 years;no mental disorder (dsm-iv). included: 20 persons. * 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. * 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. * 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 * statistics: linear mixed model for longitudinal analyses of effects; other uni- and multivariate methods (spss 12.0 - pasw statistics 18).

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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)

Keywords: schizophrenia schizophreniform disorders schizoaffective disorder psychotic disorders randomized controlled trials longitudinal studies fatty acids, omega-3 eicosapentaenoic acid vitamins antioxidants ascorbic acid alpha-tocopherol placebos antipsychotic agents oxidative stress fatty acids, unsaturated phospholipases niacin adverse effects delusions hallucinations neuropsychological tests attention memory hypertriglyceridemia models, statistical