Ethyl-EPA Treatment of Prodromal Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00634361
First received: March 6, 2008
Last updated: May 21, 2014
Last verified: May 2014
  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: 7
Study Start Date: September 2001
Study Completion Date: August 2005
Primary Completion Date: August 2005 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00634361     History of Changes
Obsolete Identifiers: NCT00237835
Other Study ID Numbers: LA01.03.0011
Study First Received: March 6, 2008
Last Updated: May 21, 2014
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 July 26, 2014