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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT04210804
Eligibility Criteria:
Inclusion Criteria:
1. Able to give written informed consent and comply with the study protocol.
2. An established diagnosis of bipolar disorder (either type I or II) and have had at least 3 previous episodes of illness within the previous 5 years or 2 episodes in the last 12 months.
To be eligible for inclusion, each subject must meet each of the inclusion criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2).
Exclusion Criteria:
* Severity of their bipolar disorder is such that participation in a clinical trial is not appropriate because of the risk of imminent self-harm or psychiatric admission,
* A concurrent medical condition (intracranial brain lesion),
* Medication (steroids) that may be accounting for the mood episodes,
* Participant is taking omega-3 PUFA supplements at the time of study entry or in the previous 12 weeks
* Individuals who are participating in another study where they are receiving a different investigational agent during the course, or within the 12 week period prior to their inclusion in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04210804
Study Brief:
Protocol Section:
NCT04210804