Irish Omega-3 Study

Psychotic Disorders Clinical Trial

Official title:

Randomized Control Trial of Omega-3 Fatty Acids Compared to Placebo in the Prevention of Psychosis in Very High Risk Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02848469
• Other study ID #: SMRI 11T-011
• Status: Recruiting
• Phase: Phase 2
• First received: July 25, 2016
• Last updated: July 25, 2016
• Start date: September 2013
• Est. completion date: February 2018

Study information

• Verified date: July 2016
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
Ireland	Clinical Research Facility	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No