Irish Omega-3 Study

Randomized Control Trial of Omega-3 Fatty Acids Compared to Placebo in the Prevention of Psychosis in Very High Risk Individuals

The Irish Omega-3 study is a clinical trial designed to investigate the potential of Omega-3 fatty acids in the reduction of risk of psychosis.

The study is being coordinated by the HRB Clinical Research Facility at University College Cork. The Principal Investigator is Dr Maeve Rooney, Consultant Psychiatrist in the Mercy University Hospital, Cork. The study will be carried out in collaboration with the HRB Clinical Research Facility in Dublin in prior to rolling out to other centres around Ireland.

The Study is funded by Stanley Medical Research Institute, a non-profit organization supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder. It is the largest provider of funding for research in serious mental illness outside of the U.S. government.

Study Overview

• Status: Unknown
• Conditions: Psychotic Disorders
• Intervention / Treatment: Dietary supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland, T12 WE28
    • Recruiting
    • Clinical Research Facility
    • Contact: Damian O'Driscoll; Phone Number: 00353214901926; Email: damianodriscoll@ucc.ie
    • Principal Investigator: Maeve Rooney

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will be aged between 13 and 50 years.
• Written informed consent will be obtained from subjects, or, in the case of those under - eighteen, from their parent or guardian, with the assent of the participant.
• Subjects meet the criteria of UHR, according to the Structured Interview for Prodromal Syndromes (SIPS) (Cannon et al., 2008, Woods et al., 2009).

Exclusion Criteria:

• Previous psychotic episode of at least one week's duration.
• Previous manic episode of at least one week's duration.
• Acute suicidal or aggressive behaviour.
• Substance dependence.
• Lactose intolerance/Milk allergy
• Intellectual disability, which in the opinion of the investigator would affect the person's ability to participate in the trial.
• Previous treatment with an antipsychotic or mood stabiliser for a psychiatric indication longer than 2 weeks in the previous three months.
• Consumption of over the counter or prescribed omega-3 fatty acids supplements within 12 weeks of entering the trial.
• Pregnancy/breast-feeding.
• Severe inter-current illness that may affect the ability of the participant to take part in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omega-3 fatty acids; Subjects will receive food supplements in the form of 200ml juice drinks, containing either the active component, 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid, or matching placebo for a duration of six months. Neither the active nor the placebo food supplements taste of fish, so the subject will be blind to whether he/she is receiving the active intervention or placebo.	Dietary supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid
Placebo Comparator: placebo 200ml juice drinks; 200ml juice drinks	Dietary supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To ascertain the effectiveness of Omega-3 fatty acid supplements in reducing transition to psychosis in individuals who are at ultra high risk of developing psychosis.	The primary endpoint will be transition to psychosis, as determined by the Structured Interview for Psychosis-Risk Syndromes (SIPS).	Assessments at baseline, 12 weeks, 24 weeks and 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
2. To assess in a subgroup of subjects the association of fatty acid changes, that is the blood Omega-3 to Omega-6 ratio, with the primary outcome.	Samples taken at baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University College Cork

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: SMRI 11T-011