---
title: Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants
nct_id: NCT00419146
overall_status: COMPLETED
phase: PHASE2, PHASE3
sponsor: University Hospital, Aker
study_type: INTERVENTIONAL
primary_condition: Schizophrenia
countries: Norway
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00419146.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00419146"
ct_last_update_post_date: 2011-01-04
last_seen_at: "2026-05-12T06:14:47.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants

**Official Title:** A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders

**NCT ID:** [NCT00419146](https://clinicaltrials.gov/study/NCT00419146)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 99
- **Lead Sponsor:** University Hospital, Aker
- **Collaborators:** Diakonhjemmet Hospital, Stanley Medical Research Institute, Laxdale Ltd, Scandinavian Society for Psychopharmacology, Shipowner Emil Stray's legacy, Johanne and Einar Eilertsen's research fund, AstraZeneca, Solveig and Johan P. Sommer's foundation, Josef and Haldis Andresen's legacy, University of Oslo, Norwegian University of Science and Technology
- **Conditions:** Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder, Psychotic Disorders
- **Start Date:** 2001-09
- **Completion Date:** 2004-04
- **CT.gov Last Update:** 2011-01-04

## Brief 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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)
```

## Arms

- **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)

## Interventions

- **Ethyl-eicosapentaenoic acid (EPA)** (DRUG) — Capsules, 2 g per day for 16 weeks
- **Vitamins E + C** (DRUG) — 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.
- **Vitamins E+C (placebo)** (OTHER) — Tablets containing dicalciumphosphate

## 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)** _(time frame: Weeks 0, 8, 16)_
- **WONCA-COOP FUNCTIONAL HEALTH ASSESSMENT CHARTS** _(time frame: Weeks 0, 8, 16)_
- **NIACIN SKIN FLUSH TEST** _(time frame: Weeks 0, 8, 16)_
- **THE UKU SIDE EFFECT RATING SCALE (USERS)** _(time frame: Weeks 0,4,8,12,16)_
- **SERIOUS ADVERSE EVENTS** _(time frame: Weeks 0,4,8,12,16)_
- **CONCOMITANT ANTIPSYCHOTIC MEDICATION** _(time frame: Weeks 0,4,8,12,16)_
- **Kimura Recurring Recognition Figures Test** _(time frame: Weeks 0, 16)_
- **Hopkins Verbal Learning Test.** _(time frame: Weeks 0, 16)_
- **Continuous Performance Test** _(time frame: Weeks 0, 16)_
- **Hopkins Verbal Learning Test** _(time frame: Weeks 0, 16)_
- **Paced Auditory Serial Addition Test** _(time frame: Weeks 0, 16)_
- **Stroop Test** _(time frame: Weeks 0, 16)_
- **Digit Span** _(time frame: Weeks 0, 16)_
- **The Letter - Number Task** _(time frame: Weeks 0,16)_
- **Semantic and Category Fluency** _(time frame: Weeks 0, 16)_
- **Body Mass Index** _(time frame: Weeks 0, 16)_
- **Blood pressure - systolic, diastolic** _(time frame: Weeks 0, 16)_
- **Heart rate** _(time frame: Weeks 0, 16)_
- **Albumin** _(time frame: Weeks 0, 16)_
- **Urate** _(time frame: Weeks 0, 16)_
- **Glucose** _(time frame: Weeks 0, 16)_
- **Cholesterol** _(time frame: Weeks 0, 16)_
- **Triglycerides** _(time frame: Weeks 0, 16)_
- **Fatty acids in red blood cells** _(time frame: Weeks 0, 16)_
- **Alpha-tocopherol adjusted for [triglycerides]+[cholesterol].** _(time frame: Weeks 0, 16)_
- **Total antioxidant status** _(time frame: Weeks 0, 16)_
- **Malondialdehyde** _(time frame: Weeks 0, 16)_
- **F2-isoprostane (8-epiPGF2-alpha)** _(time frame: Weeks 0, 16)_
- **Cytosolic PLA2 group IV in red blood cells(ELISA method)**
- **Gene expression of mRNA for Phospholipase A2 (PLA2) groups IVa and VIa in monocytes.** _(time frame: Weeks 0, 16)_
- **Mean Corpuscular Haemoglobin Concentration (MCHC)** _(time frame: Weeks 0, 16)_
- **Mean Corpuscular Volume (MCV)** _(time frame: Weeks 0, 16)_
- **C- Reactive Protein (CRP)** _(time frame: Weeks 0, 16)_
- **Haemoglobin** _(time frame: Weeks 0, 16)_
- **Leukocytes** _(time frame: Weeks 0, 16)_
- **Calcium** _(time frame: Weeks 0, 16)_
- **Sodium** _(time frame: Weeks 0, 16)_
- **Potassium** _(time frame: Weeks 0, 16)_
- **Ferritin** _(time frame: Weeks 0,16)_
- **Free thyroxin (T4)** _(time frame: Weeks 0, 16)_
- **Thyroid Stimulating Hormone (TSH)** _(time frame: Weeks 0, 16)_

## Locations (1)

- Aker University Hospital, Oslo, Norway

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.aker university hospital|oslo||norway` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00419146.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00419146*  
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