Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2004-04-30

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia Schizophreniform Disorders Schizoaffective Disorder Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamins E+C (placebo)

Tablets containing dicalciumphosphate

Intervention Type OTHER

Other Intervention Names

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Provided by Laxdale Ltd., Scotland, UK CellaVie (Ferrosan AS, Denmark) Placebo EPA Placebo CellaVie, provided by Ferrosan AS, Denmark

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes