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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT04158869
Eligibility Criteria:
For cases: participants enrolled in the IICT and therefore meeting the criterie for participation in the IICT will be selected.
For controls, participants fulfilling all of the following inlclusion criterie are eligible for the study
Inclusion Criteria:
* Participants of female and male sex
* Children aged 8 to ≤ 13 years or teenagers 13 to \< 18 years at time of study entry
* Written informed assent of the subject (appendix informed consent forms) and written in formed consent form from the subjects' parents/legal representatives
* No present primary diagnosed psychiatric disorder according to the M.I.N.I. KID Test.
* No use of chronic medication
* Able to communicate in German; degree of understanding sufficient to comply with trial procedure
Exclusion Criteria:
* More than 4 weeks of regular n-3 FA supplementation (\>2 daily capsules standard strength providing \> 600 mg combined EPA/DHA) within the last 6 months.
* Women who are self-reported pregnant or breast feeding.
* Self-reported pre-existing neurological (such as e.g. brain tumour, temporal lobe epilepsy, HIV encephalopathy) or medical conditions (ICD-10 F06-F07) likely to be a risk factor for developing depressive symptoms
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT04158869
Study Brief:
Protocol Section:
NCT04158869