Irish Omega-3 Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Dietary Supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3 fatty acids<br>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<br> <br> |
| Placebo Comparator: placebo 200ml juice drinks<br>200ml juice drinks | Dietary Supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid<br> <br> |

What is the study measuring?
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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 | Measure Description | 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 |