Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT02848469
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
45 Years
Study:
NCT02848469
Study Brief:
Protocol Section:
NCT02848469