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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158869
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Psychiatric University Hospital, Zurich
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

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.


Condition or disease
Major Depressive Disorder Depression Child Mental Disorder

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Group/Cohort
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



Primary Outcome Measures :
  1. n-3 fatty acid intake [ Time Frame: 6 months ]
    Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire

  2. n-3 fatty acid status [ Time Frame: 1 day ]
    Measurement of relative amount of n-3 fatty acids

  3. Pediatric depressive symptoms [ 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


Secondary Outcome Measures :
  1. Fatty acid metabolism [ Time Frame: 1 day ]
    Measurement of lipid mediators

  2. Biomarkers related to brain health [ Time Frame: 1 day ]
    Measurement of brain-derived neurotrophic factor (BDNF), kynurenine pathway metabolites, and monoamine neurotransmitters

  3. Biomarkers related to systemic inflammation [ Time Frame: 1 day ]
    Measurement of C-reactive Protein (CRP), alpha-1-acid glycoprotein, and cytokines

  4. Biomarkers related to gut microbiota [ Time Frame: 1 day ]

    Measurement of

    • gut microbiome composition with 16S rRNA sequencing
    • Faecal calprotectin
    • Intestinal fatty acid binding protein

  5. Biomarkers related to nutritional status [ Time Frame: 1 day ]
    Measurement of iron and iodine status


Other Outcome Measures:
  1. Verbal learning and memory test (VLMT) [ Time Frame: 1 day ]
    Differences in scores between cases and controls

  2. Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: 1 day ]
    Differences in the overall score between cases and controls

  3. Digit span measured by the Wechsler Intelligence Scale for children (WISC-IV) [ Time Frame: 1 day ]
    Differences in scores between cases and controls

  4. Emotion recognition measured with the Amsterdam Neuropsychological Task (ANT) program [ Time Frame: 1 day ]
    Differences in scores between cases and controls

  5. Attentional flexibility measured with the shifting attentional set of the Amsterdam Neuropsychological Task (ANT) program [ Time Frame: 1 day ]
    Differences in reaction times between cases and controls

  6. Regensburg Word Fluency Test (RWT) [ Time Frame: 1 day ]
    Differences in scores between cases and controls

  7. Reynolds Intellectual Assessment Scales (RIAS) [ Time Frame: 1 day ]
    Differences in scores between cases and controls

  8. Suicidal ideation Questionnaire (SIQ) [ Time Frame: 1 month ]
    Differences in scores between cases and controls

  9. Scale of Impulsivity and Emotion Dysregulation (IES-27) [ Time Frame: 1 month ]
    Differences in scores between cases and controls

  10. Childhood Trauma Questionnaire (CTQ) [ Time Frame: 1 day ]
    Differences in scores between cases and controls

  11. Strenght and Difficulty Questionnaire (SDQ) [ Time Frame: 1 day ]
    Differences in scores between cases and controls

  12. Perceived Stress Scale (PSS-10) [ Time Frame: 1 month ]
    Differences in scores between cases and controls

  13. Children's Depression Inventory (DIKJ) [ Time Frame: 1 month ]
    Differences in scores between cases and controls

  14. Connor Davidson Resilience Scale (CDRS) [ Time Frame: 1 month ]
    Differences in scores between cases and controls

  15. Beck Anxiety Inventory (BAI) [ Time Frame: 1 month ]
    Differences in scores between cases and controls


Biospecimen Retention:   Samples With DNA
Blood, urine, saliva, hair, and stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children/adolescents in German speaking Switzerland
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158869


Contacts
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Contact: Ester Osuna, PhD student +41 44 632 4315 ester.osuna@hest.ethz.ch
Contact: Jeannine Baumgartner, Dr. +41 44 632 8634 jeannine.baumgartner@hest.ethz.ch

Locations
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Switzerland
ETH Zürich Recruiting
Zürich, Switzerland, 8092
Contact: Ester Osuna, PhD student    0041446324315    ester.osuna@hest.ethz.ch   
Contact: Jeannine Baumgartner, Dr.    004144 6328634    jeannine.baumgartner@hest.ethz.ch   
Principal Investigator: Jeannine Baumgartner, Dr.         
Principal Investigator: Isabelle Herter-Aeberli, Dr.         
Sponsors and Collaborators
Swiss Federal Institute of Technology
Psychiatric University Hospital, Zurich
Investigators
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Study Chair: Gregor Berger, Dr. med. Psychiatrische Universitätsklinik Zürich
Principal Investigator: 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
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT04158869    
Other Study ID Numbers: n-3 case-control study
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A BioBank will be established. Access to the Biobank can be requested upon completion of the IICT and the add-on study contacting the principal investigator Dr. Jeannine Baumgartner
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: upon study completion of the IICT and the add-on study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swiss Federal Institute of Technology:
n-3 fatty acids
pediatric Major Depressive Disorder
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Neurodevelopmental Disorders
Pathologic Processes
Behavioral Symptoms
Mood Disorders