Irish Omega-3 Study

NCT ID: NCT02848469

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid

Intervention Type: DIETARY_SUPPLEMENT

placebo 200ml juice drinks

200ml juice drinks

Group Type: PLACEBO_COMPARATOR

1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid

Intervention Type: DIETARY_SUPPLEMENT

Interventions

1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Cork

OTHER

Sponsor Role: lead

Responsible Party

Damian O'Driscoll

Academic Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Research Facility

Cork, , Ireland

Site Status: RECRUITING

Countries

Ireland

Facility Contacts

Damian O'Driscoll

Role: primary

damianodriscoll@ucc.ie

00353214901926

Other Identifiers

SMRI 11T-011

Identifier Type: -

Identifier Source: org_study_id