Irish Omega-3 Study

Phase 2

• Conditions: Psychotic Disorders
• Interventions: Dietary Supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid

• Registration Number: NCT02848469
• Lead Sponsor: University College Cork

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Status Verified: 2016-07
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo 200ml juice drinks	1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid	200ml juice drinks
Omega-3 fatty acids	1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid	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.

Primary Outcome Measures

Name	Time	Method
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.	Assessments at baseline, 12 weeks, 24 weeks and 52 weeks	The primary endpoint will be transition to psychosis, as determined by the Structured Interview for Psychosis-Risk Syndromes (SIPS).

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Research Facility; 🇮🇪 Cork, Ireland