NCT00634361

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2001

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

3.9 years

First QC Date

March 6, 2008

Last Update Submit

May 21, 2014

Conditions

Schizophrenia Prodrome

Outcome Measures

Primary Outcomes (1)

  • conversion to psychosis

    one year

Study Arms (1)

A

EXPERIMENTAL
Drug: ethyl-eicosapentaenoic acid

Interventions

ethyl-eicosapentaenoic acidDRUG

2 mg per day

Also known as: ethyl-EPA, an omega-3 fatty acid
A

Eligibility Criteria

Age14 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • meets criteria for schizophrenia prodrome

You may not qualify if:

  • any lifetime antipsychotic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

eicosapentaenoic acid ethyl ester

Study Officials

  • Scott W Woods, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2008

First Posted

March 13, 2008

Study Start

September 1, 2001

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

May 22, 2014

Record last verified: 2014-05