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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 fatty acids | Active Comparator | 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. |
|
| placebo 200ml juice drinks | Placebo Comparator | 200ml juice drinks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid | Dietary Supplement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Facility | Recruiting | Cork | T12 WE28 | Ireland |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| D008055 |
| Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |