Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-03 @ 9:49 PM
Study NCT ID:
NCT02848469
Status:
UNKNOWN
Last Update Posted:
2016-07-28
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irish Omega-3 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015118', 'term': 'Eicosapentaenoic Acid'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Assessments at baseline, 12 weeks, 24 weeks and 52 weeks', 'description': 'The primary endpoint will be transition to psychosis, as determined by the Structured Interview for Psychosis-Risk Syndromes (SIPS).'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'Samples taken at baseline and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psychotic Disorders']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects will be aged between 13 and 50 years.\n* 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.\n* Subjects meet the criteria of UHR, according to the Structured Interview for Prodromal Syndromes (SIPS) (Cannon et al., 2008, Woods et al., 2009).\n\nExclusion Criteria:\n\n* Previous psychotic episode of at least one week's duration.\n* Previous manic episode of at least one week's duration.\n* Acute suicidal or aggressive behaviour.\n* Substance dependence.\n* Lactose intolerance/Milk allergy\n* Intellectual disability, which in the opinion of the investigator would affect the person's ability to participate in the trial.\n* Previous treatment with an antipsychotic or mood stabiliser for a psychiatric indication longer than 2 weeks in the previous three months.\n* Consumption of over the counter or prescribed omega-3 fatty acids supplements within 12 weeks of entering the trial.\n* Pregnancy/breast-feeding.\n* Severe inter-current illness that may affect the ability of the participant to take part in the trial."}, 'identificationModule': {'nctId': 'NCT02848469', 'briefTitle': 'Irish Omega-3 Study', 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': 'Randomized Control Trial of Omega-3 Fatty Acids Compared to Placebo in the Prevention of Psychosis in Very High Risk Individuals', 'orgStudyIdInfo': {'id': 'SMRI 11T-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omega-3 fatty acids', 'description': '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.', 'interventionNames': ['Dietary Supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo 200ml juice drinks', 'description': '200ml juice drinks', 'interventionNames': ['Dietary Supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid']}], 'interventions': [{'name': '1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Omega-3 fatty acids', 'placebo 200ml juice drinks']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T12 WE28', 'city': 'Cork', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': "Damian O'Driscoll", 'role': 'CONTACT', 'email': 'damianodriscoll@ucc.ie', 'phone': '00353214901926'}, {'name': 'Maeve Rooney', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research Facility', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Cork', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic Study Coordinator', 'investigatorFullName': "Damian O'Driscoll", 'investigatorAffiliation': 'University College Cork'}}}}