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

NCT04158869 | Completed

• 1 other identifier: n-3 case-control study
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder; Depression; Child Mental Disorder

Keywords

n-3 fatty acids; pediatric Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• n-3 fatty acid intake

  Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire

  6 months

• n-3 fatty acid status

  Measurement of relative amount of n-3 fatty acids

  1 day

• 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 Outcomes (5)

• Fatty acid metabolism

  1 day

• Biomarkers related to brain health

  1 day

• Biomarkers related to systemic inflammation

  1 day

• Biomarkers related to gut microbiota

  1 day

• Biomarkers related to nutritional status

  1 day

Other Outcomes (15)

• Verbal learning and memory test (VLMT)

  1 day

• Behavior Rating Inventory of Executive Function (BRIEF)

  1 day

• Digit span measured by the Wechsler Intelligence Scale for children (WISC-IV)

  1 day

Study Arms (2)

Cases

Patients with pMDD, enrolled in the Investigator-initiated clinical trial IICT (ClinicalTrials.gov Identifier: NCT03167307)

Controls

Controls matched to cases according to age, sex and school education

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children/adolescents in German speaking Switzerland

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Psychiatric University Hospital, Zurich: collaborator

Study Sites (1)

ETH Zürich

Zurich, 8092, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, saliva, hair, and stool

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Gregor Berger, Dr. med.

  Psychiatrische Universitätsklinik Zürich

  STUDY CHAIR

• Jeannine Baumgartner, Dr.

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

• Isabelle Herter-Aeberli, Dr.

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

• Michael B Zimmermann, Dr. med.

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: November 12, 2019
• Study Start: September 16, 2019
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: upon study completion of the IICT and the add-on study.

Locations

CH (1)