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Irish Omega-3 Study

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ClinicalTrials.gov Identifier: NCT02848469
Recruitment Status : Unknown
Verified July 2016 by Damian O'Driscoll, University College Cork.
Recruitment status was:  Recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Damian O'Driscoll, 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.


Condition or disease Intervention/treatment Phase
Psychotic Disorders Dietary Supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Omega-3 Fatty Acids Compared to Placebo in the Prevention of Psychosis in Very High Risk Individuals
Study Start Date : September 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. 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. [ Time Frame: Samples taken at baseline and 12 weeks ]


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Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848469


Locations
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Ireland
Clinical Research Facility Recruiting
Cork, Ireland, T12 WE28
Contact: Damian O'Driscoll    00353214901926    damianodriscoll@ucc.ie   
Principal Investigator: Maeve Rooney         
Sponsors and Collaborators
University College Cork

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Responsible Party: Damian O'Driscoll, Academic Study Coordinator, University College Cork
ClinicalTrials.gov Identifier: NCT02848469     History of Changes
Other Study ID Numbers: SMRI 11T-011
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders