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Irish Omega-3 Study

Primary Purpose

Psychotic Disorders

Status
Unknown status
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

13 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omega-3 fatty acids

placebo 200ml juice drinks

Arm 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.

200ml juice drinks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
July 25, 2016
Last Updated
July 25, 2016
Sponsor
University College Cork
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1. Study Identification

Unique Protocol Identification Number
NCT02848469
Brief Title
Irish Omega-3 Study
Official Title
Randomized Control Trial of Omega-3 Fatty Acids Compared to Placebo in the Prevention of Psychosis in Very High Risk Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 fatty acids
Arm Type
Active Comparator
Arm 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.
Arm Title
placebo 200ml juice drinks
Arm Type
Placebo Comparator
Arm Description
200ml juice drinks
Intervention Type
Dietary Supplement
Intervention Name(s)
1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid
Primary Outcome Measure Information:
Title
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.
Description
The primary endpoint will be transition to psychosis, as determined by the Structured Interview for Psychosis-Risk Syndromes (SIPS).
Time Frame
Assessments at baseline, 12 weeks, 24 weeks and 52 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Clinical Research Facility
City
Cork
ZIP/Postal Code
T12 WE28
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damian O'Driscoll
Phone
00353214901926
Email
damianodriscoll@ucc.ie
First Name & Middle Initial & Last Name & Degree
Maeve Rooney

12. IPD Sharing Statement

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Irish Omega-3 Study

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