Ethyl-EPA Treatment of Prodromal Patients
Primary Purpose
Schizophrenia Prodrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ethyl-eicosapentaenoic acid
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia Prodrome
Eligibility Criteria
Inclusion Criteria:
- meets criteria for schizophrenia prodrome
Exclusion Criteria:
- any lifetime antipsychotic treatment
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
conversion to psychosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00634361
Brief Title
Ethyl-EPA Treatment of Prodromal Patients
Official Title
Ethyl-EPA Treatment of Prodromal Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Prodrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ethyl-eicosapentaenoic acid
Other Intervention Name(s)
ethyl-EPA, an omega-3 fatty acid
Intervention Description
2 mg per day
Primary Outcome Measure Information:
Title
conversion to psychosis
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
meets criteria for schizophrenia prodrome
Exclusion Criteria:
any lifetime antipsychotic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott W Woods, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ethyl-EPA Treatment of Prodromal Patients
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