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Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis

NCT00396643 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2007-12-27

No results posted yet for this study

Summary

Early intervention in psychosis might be associated with better outcomes. However, intervention in the pre-psychotic phase has been questioned as, using current criteria, only 20-50% of individuals classified as prodromal develop a psychotic disorder within a 1-2 years period. Treatment agents investigated in the pre-psychotic phase of schizophrenia and other psychotic disorders should, therefore, not have major side effects. This proposal investigates omega-3 fatty acids (1.2 gramm per day eicosapentaenoic acid/docosahexaenoic acid;EPA/DHA) as a beneficial and possible preventive therapeutic agent in young people at ultra high-risk for developing a psychotic disorder.

Conditions

Interventions

DRUG

Omega 3 fatty acids

The active treatment is a supplement of yellow gelatin 0.5 g fish oil capsules. The daily dose of 4 (2x2) capsules provides 700 mg of eicosapentaenoic acid and 500 mg of docosahexaenoic acid, and 10 mg of Vitamin E. Placebo treatment comprises coconut oil capsules, carefully matched with the active treatment with respect to both appearance and flavor, also containing 10 mg Vitamin E, and 10 mg of fish oil to mimic taste. Coconut oil was chosen as placebo because it does not contain polyunsaturated fatty acids and has no impact on n-3 fatty acid metabolism. The intervention period is 12 weeks.

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • G Paul Amminger, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396643 on ClinicalTrials.gov