Irish Omega-3 Study

NCT02848469 | Unknown Phase 2

• 1 other identifier: SMRI 11T-011
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (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.

  Samples taken at baseline and 12 weeks

Study Arms (2)

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.

Dietary Supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid

placebo 200ml juice drinks

PLACEBO COMPARATOR

200ml juice drinks

Dietary Supplement: 1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid

Interventions

1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid DIETARY_SUPPLEMENT

Omega-3 fatty acids; placebo 200ml juice drinks

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Clinical Research Facility

Cork, T12 WE28, Ireland

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Study Coordinator

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: September 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

IE (1)