Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants
A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders
PhasePhase 2/Phase 3
Lead SponsorUniversity of Antwerp
StatusCompleted No Results Posted
Indication/ConditionSchizophrenia Schizophreniform Disorders Schizoaffective Disorder Psychotic Disorders
Intervention/Treatmentvitamin e icosapent ethyl vitamin c ...
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.
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.
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).
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
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)