Trial | NCT00419146  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    99
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).
Study Started
Sep 30
2001
Primary Completion
Apr 30
2004
Study Completion
Apr 30
2004
Last Update
Jan 04
2011
Estimate

Drug Ethyl-eicosapentaenoic acid (EPA)

Capsules, 2 g per day for 16 weeks

  • Other names: Provided by Laxdale Ltd., Scotland, UK

Drug Vitamins E + C

RRR-alpha-tocopherol 392 mg + slow-release ascorbic acid 1000 mg per day, for 16 weeks

  • Other names: CellaVie (Ferrosan AS, Denmark)

Other Etyl EPA (placebo)

Paraffin oil. Capsules, each 0.5 g.

  • Other names: Placebo EPA

Other Vitamins E+C (placebo)

Tablets containing dicalciumphosphate

  • Other names: Placebo CellaVie, provided by Ferrosan AS, Denmark

Ethyl EPA (active) and Vitamins E + C (active) Experimental

Ethyl EPA (active) and Vitamins E+C (placebo) Experimental

Ethyl EPA (placebo) and Vitamins E+C (active) Experimental

Ethyl EPA (placebo) and Vitamins E+C (placebo) Placebo Comparator

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)
No Results Posted