ETH Zürich
Zurich, 8092, Switzerland
NCT Number: NCT04158869
This is an observational case-control add-on study to an investigator-initiated clinical trial (IICT) (ClinicalTrials.gov Identifier: NCT03167307): Omega-3 fatty acids as firstline treatment in pediatric depression. A 36-week multi-centre, double-blind, placebo-controlled randomized superiority study.
This project will recruit a healthy control group matched for age and sex to a sub-group of patients with diagnosed pediatric major depressive disorder (pMDD) enrolled in the IICT. The aim is to investigate the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD, and explore potential biochemical mechanisms underlying this relationship by measuring biomarkers related to n-3 FA metabolism, mental health and cognitive function.
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Notify Me8 year–17 year
All sexes
Observational
Zurich, 8092, Switzerland
According to a recent school survey, one out of ten adolescents in Zurich have moderate to marked depressive symptoms. Early onset of paediatric major depressive disorder (pMDD) is a risk factor for chronic and recurrent forms of depression in adulthood (MDD). MDD is associated with difficulties in relationships, impaired school and work performance, and an increased risk of substance abuse. Furthermore, MDD is a major contributor to the burden of suicide and poor long-term health late in life. The emerging potential of n-3 polyunsaturated fatty acids (n-3 PUFAs), also known in short as omega-3 fatty acids (n-3 FAs), for the treatment of MDD is being investigated in several studies. Previous observational studies suggest a link between the consumption of n-3PUFA-rich food and the level of depressive symptoms. However, studies that investigated the potential beneficial effects of n-3 PUFA supplementation for the treatment of MDD compared with placebo showed inconsistent findings.
Primary objectives of this project are:
Participants meeting the following criteria are eligible for the study:
Inclusion criteria
Exclusion criteria
In a first step participants will be screened for in- and exclusion criteria. If participants can be included into the study we will
This study aims to recruit a total of 200 participants: 100 cases (from IICT) and 100 controls (recruited for this study).
There will be a total recruiting period of 18 months.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Exclusion criteria
Time frame: 6 months
Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire
Time frame: 1 day
Measurement of relative amount of n-3 fatty acids
Time frame: 2 weeks
Quantification of depressive symptoms with "Children's Depression Rating Scale - Revised" (CDRS-R) total score; Scale from 17 to >72; values >40 rated as moderate depression
Time frame: 1 day
Measurement of lipid mediators
Time frame: 1 day
Measurement of brain-derived neurotrophic factor (BDNF), kynurenine pathway metabolites, and monoamine neurotransmitters
Time frame: 1 day
Measurement of C-reactive Protein (CRP), alpha-1-acid glycoprotein, and cytokines
Time frame: 1 day
Measurement of
Time frame: 1 day
Measurement of iron and iodine status
Time frame: 1 day
Differences in scores between cases and controls
Time frame: 1 day
Differences in the overall score between cases and controls
Time frame: 1 day
Differences in scores between cases and controls
Time frame: 1 day
Differences in scores between cases and controls
Time frame: 1 day
Differences in reaction times between cases and controls
Time frame: 1 day
Differences in scores between cases and controls
Time frame: 1 day
Differences in scores between cases and controls
Time frame: 1 month
Differences in scores between cases and controls
Time frame: 1 month
Differences in scores between cases and controls
Time frame: 1 day
Differences in scores between cases and controls
Time frame: 1 day
Differences in scores between cases and controls
Time frame: 1 month
Differences in scores between cases and controls
Time frame: 1 month
Differences in scores between cases and controls
Time frame: 1 month
Differences in scores between cases and controls
Time frame: 1 month
Differences in scores between cases and controls
Swiss Federal Institute of Technology
Other
An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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