NCT00419146

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University Hospital, Aker · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Schizophrenia
• Schizophreniform Disorders
• Schizoaffective Disorder
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	Ethyl-eicosapentaenoic acid (EPA)	Capsules, 2 g per day for 16 weeks
DRUG	Vitamins E + C	RRR-alpha-tocopherol 392 mg + slow-release ascorbic acid 1000 mg per day, for 16 weeks
OTHER	Etyl EPA (placebo)	Paraffin oil. Capsules, each 0.5 g.
OTHER	Vitamins E+C (placebo)	Tablets containing dicalciumphosphate

Timeline

• Start date: 2001-09-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2007-01-08
• Last updated: 2011-01-04

Locations

1 site across 1 country: Norway