An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents

Depression Clinical Trial

Official title:

An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158869
• Other study ID #: n-3 case-control study
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: December 22, 2020

Study information

• Verified date: January 2022
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. To determine the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD.

2. To explore biochemical mechanisms underlying this relationship by measuring biomarkers related to n-3 FA metabolism, mental health, cognitive function, and potential pathways linking n-3 FA intake/status and brain health (e.g. immune system, gut microbiome-brain-axis).

Participants meeting the following criteria 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 and written informed consent from the subject's parents/legal representatives

• No present primary diagnosed psychiatric disorder according to the M.I.N.I. KID Test

Exclusion criteria:

• More than 4 weeks of regular n-3 FA supplementation

• Women who are self-reported pregnant or breast feeding

• Pre-existing neurological or medical conditions likely to be a risk factor for developing depressive symptoms

In a first step participants will be screened for in- and exclusion criteria. If participants can be included into the study we will

• Measure participant's mental health with behavioural and cognitive assessments

• Collect biological samples from participants (blood, urine, saliva, hair, and stool)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Mental Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorders
• Neurodevelopmental Disorders

Locations

Country	Name	City	State
Switzerland	ETH Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Verbal learning and memory test (VLMT)	Differences in scores between cases and controls	1 day
Other	Behavior Rating Inventory of Executive Function (BRIEF)	Differences in the overall score between cases and controls	1 day
Other	Digit span measured by the Wechsler Intelligence Scale for children (WISC-IV)	Differences in scores between cases and controls	1 day
Other	Emotion recognition measured with the Amsterdam Neuropsychological Task (ANT) program	Differences in scores between cases and controls	1 day
Other	Attentional flexibility measured with the shifting attentional set of the Amsterdam Neuropsychological Task (ANT) program	Differences in reaction times between cases and controls	1 day
Other	Regensburg Word Fluency Test (RWT)	Differences in scores between cases and controls	1 day
Other	Reynolds Intellectual Assessment Scales (RIAS)	Differences in scores between cases and controls	1 day
Other	Suicidal ideation Questionnaire (SIQ)	Differences in scores between cases and controls	1 month
Other	Scale of Impulsivity and Emotion Dysregulation (IES-27)	Differences in scores between cases and controls	1 month
Other	Childhood Trauma Questionnaire (CTQ)	Differences in scores between cases and controls	1 day
Other	Strenght and Difficulty Questionnaire (SDQ)	Differences in scores between cases and controls	1 day
Other	Perceived Stress Scale (PSS-10)	Differences in scores between cases and controls	1 month
Other	Children's Depression Inventory (DIKJ)	Differences in scores between cases and controls	1 month
Other	Connor Davidson Resilience Scale (CDRS)	Differences in scores between cases and controls	1 month
Other	Beck Anxiety Inventory (BAI)	Differences in scores between cases and controls	1 month
Primary	n-3 fatty acid intake	Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire	6 months
Primary	n-3 fatty acid status	Measurement of relative amount of n-3 fatty acids	1 day
Primary	Pediatric depressive symptoms	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	2 weeks
Secondary	Fatty acid metabolism	Measurement of lipid mediators	1 day
Secondary	Biomarkers related to brain health	Measurement of brain-derived neurotrophic factor (BDNF), kynurenine pathway metabolites, and monoamine neurotransmitters	1 day
Secondary	Biomarkers related to systemic inflammation	Measurement of C-reactive Protein (CRP), alpha-1-acid glycoprotein, and cytokines	1 day
Secondary	Biomarkers related to gut microbiota	Measurement of; gut microbiome composition with 16S rRNA sequencing; Faecal calprotectin; Intestinal fatty acid binding protein	1 day
Secondary	Biomarkers related to nutritional status	Measurement of iron and iodine status	1 day