Ethyl-EPA Treatment of Prodromal Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00634361
First received: March 6, 2008
Last updated: March 12, 2008
Last verified: March 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: A Drug: ethyl-eicosapentaenoic acid
2 mg per day
Other Name: ethyl-EPA, an omega-3 fatty acid

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

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

ClinicalTrials.gov processed this record on April 15, 2014