Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants
Condition: Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorder; Psychotic Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      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).
    

Intervention name(s): Ethyl-eicosapentaenoic acid (EPA); Vitamins E + C; Etyl EPA (placebo); Vitamins E+C (placebo)
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Capsules, 2 g per day for 16 weeks; RRR-alpha-tocopherol 392 mg + slow-release ascorbic acid 1000 mg per day, for 16 weeks; Paraffin oil. Capsules, each 0.5 g.; Tablets containing dicalciumphosphate
Other intervention name(s): Provided by Laxdale Ltd., Scotland, UK; CellaVie (Ferrosan AS, Denmark); Placebo EPA; Placebo CellaVie, provided by Ferrosan AS, Denmark
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
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