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Ethyl-EPA Treatment of Prodromal Patients
This study is ongoing, but not recruiting participants.
First Received: March 6, 2008   Last Updated: March 12, 2008   History of Changes
Sponsored by: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00634361
  Purpose

This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome.


Condition Intervention Phase
Schizophrenia Prodrome
Drug: ethyl-eicosapentaenoic acid
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: Ethyl-EPA Treatment of Prodromal Patients

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • conversion to psychosis [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: September 2001
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: ethyl-eicosapentaenoic acid
2 mg per day

  Eligibility

Ages Eligible for Study:   14 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • meets criteria for schizophrenia prodrome

Exclusion Criteria:

  • any lifetime antipsychotic treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634361

Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Scott W Woods, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University School of Medicine ( Scott W. Woods, M.D. )
Study ID Numbers: LA01.03.0011
Study First Received: March 6, 2008
Last Updated: March 12, 2008
ClinicalTrials.gov Identifier: NCT00634361     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Omega 3 Fatty Acid
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009