NCT00419146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Sep 2001

Typical duration for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
Last Updated

January 4, 2011

Status Verified

August 1, 2010

Enrollment Period

2.6 years

First QC Date

January 5, 2007

Last Update Submit

January 3, 2011

Conditions

SchizophreniaSchizophreniform DisordersSchizoaffective DisorderPsychotic Disorders

Keywords

SchizophreniaSchizophreniform disordersSchizoaffective disorderPsychotic disordersRandomized Controlled TrialsLongitudinal StudiesFatty Acids, Omega-3Eicosapentaenoic AcidVitaminsAntioxidantsAscorbic AcidAlpha-TocopherolPlacebosAntipsychotic AgentsOxidative StressFatty Acids, UnsaturatedPhospholipasesNiacinAdverse effectsDelusionsHallucinationsNeuropsychological TestsAttentionMemoryHypertriglyceridemiaModels, Statistical

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale (PANSS)- Total

    Baseline - 8 weeks - 16 weeks

Secondary Outcomes (42)

  • PANSS Subscales Negative, Positive, General Psychopathology

    Weeks 0, 8, 16

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

    Weeks 0, 8, 16

  • WONCA-COOP FUNCTIONAL HEALTH ASSESSMENT CHARTS

    Weeks 0, 8, 16

  • NIACIN SKIN FLUSH TEST

    Weeks 0, 8, 16

  • THE UKU SIDE EFFECT RATING SCALE (USERS)

    Weeks 0,4,8,12,16

  • +37 more secondary outcomes

Study Arms (4)

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

EXPERIMENTAL
Drug: Ethyl-eicosapentaenoic acid (EPA)Drug: Vitamins E + C

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

EXPERIMENTAL
Drug: Ethyl-eicosapentaenoic acid (EPA)Other: Vitamins E+C (placebo)

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

EXPERIMENTAL
Drug: Vitamins E + COther: Etyl EPA (placebo)

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

PLACEBO COMPARATOR
Other: Vitamins E+C (placebo)

Interventions

Ethyl-eicosapentaenoic acid (EPA)DRUG

Capsules, 2 g per day for 16 weeks

Also known as: Provided by Laxdale Ltd., Scotland, UK
Ethyl EPA (active) and Vitamins E + C (active)Ethyl EPA (active) and Vitamins E+C (placebo)
Vitamins E + CDRUG

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

Also known as: CellaVie (Ferrosan AS, Denmark)
Ethyl EPA (active) and Vitamins E + C (active)Ethyl EPA (placebo) and Vitamins E+C (active)
Etyl EPA (placebo)OTHER

Paraffin oil. Capsules, each 0.5 g.

Also known as: Placebo EPA
Ethyl EPA (placebo) and Vitamins E+C (active)
Vitamins E+C (placebo)OTHER

Tablets containing dicalciumphosphate

Also known as: Placebo CellaVie, provided by Ferrosan AS, Denmark
Ethyl EPA (active) and Vitamins E+C (placebo)Ethyl EPA (placebo) and Vitamins E+C (placebo)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aker University Hospital

Oslo, 0320, Norway

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersDelusionsHallucinationsHypertriglyceridemia

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehaviorPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Håvard Bentsen, MD PhD

    Aker University Hospital (-2004), Diakonhjemmet Hospital (2004-)

    STUDY DIRECTOR

  • Odd Lingjærde, MD PhD

    University Hospital, Aker

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 8, 2007

Study Start

September 1, 2001

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

January 4, 2011

Record last verified: 2010-08

Locations

NO(1)