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

Phase 3CompletedNCT00419146

University Hospital, Aker99 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia Schizophreniform Disorders Schizoaffective Disorder Psychotic Disorders

Interventions

Ethyl-eicosapentaenoic acid (EPA)DRUG

Capsules, 2 g per day for 16 weeks

Vitamins E + CDRUG

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

Etyl EPA (placebo)OTHER

Paraffin oil. Capsules, each 0.5 g.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Aker University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Positive and Negative Syndrome Scale (PANSS)- Total

Time frame: Baseline - 8 weeks - 16 weeks

Secondary Outcomes

PANSS Subscales Negative, Positive, General Psychopathology

Time frame: Weeks 0, 8, 16

GLOBAL ASSESSMENT OF FUNCTIONING- Split Version (S-GAF)

(S-GAF)Symptom Scale (S-GAF)Function Scale

Time frame: Weeks 0, 8, 16

WONCA-COOP FUNCTIONAL HEALTH ASSESSMENT CHARTS

5 scales

Time frame: Weeks 0, 8, 16

NIACIN SKIN FLUSH TEST

2 concentrations of niacin

Time frame: Weeks 0, 8, 16

THE UKU SIDE EFFECT RATING SCALE (USERS)

1. Sum of scores 2. Patients with side effects

Time frame: Weeks 0,4,8,12,16

SERIOUS ADVERSE EVENTS

Time frame: Weeks 0,4,8,12,16

CONCOMITANT ANTIPSYCHOTIC MEDICATION

Defined Daily Doses (ATC/WHO)

Time frame: Weeks 0,4,8,12,16

Kimura Recurring Recognition Figures Test

A sub-sample of patients. For logistic reasons, only some study sites could participate.

Time frame: Weeks 0, 16

Hopkins Verbal Learning Test.

Data from ClinicalTrials.gov

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