Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 11:05 PM
Study NCT ID:
NCT04158869
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2019-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine, saliva, hair, and stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Verbal learning and memory test (VLMT)', 'timeFrame': '1 day', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Behavior Rating Inventory of Executive Function (BRIEF)', 'timeFrame': '1 day', 'description': 'Differences in the overall score between cases and controls'}, {'measure': 'Digit span measured by the Wechsler Intelligence Scale for children (WISC-IV)', 'timeFrame': '1 day', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Emotion recognition measured with the Amsterdam Neuropsychological Task (ANT) program', 'timeFrame': '1 day', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Attentional flexibility measured with the shifting attentional set of the Amsterdam Neuropsychological Task (ANT) program', 'timeFrame': '1 day', 'description': 'Differences in reaction times between cases and controls'}, {'measure': 'Regensburg Word Fluency Test (RWT)', 'timeFrame': '1 day', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Reynolds Intellectual Assessment Scales (RIAS)', 'timeFrame': '1 day', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Suicidal ideation Questionnaire (SIQ)', 'timeFrame': '1 month', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Scale of Impulsivity and Emotion Dysregulation (IES-27)', 'timeFrame': '1 month', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Childhood Trauma Questionnaire (CTQ)', 'timeFrame': '1 day', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Strenght and Difficulty Questionnaire (SDQ)', 'timeFrame': '1 day', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Perceived Stress Scale (PSS-10)', 'timeFrame': '1 month', 'description': 'Differences in scores between cases and controls'}, {'measure': "Children's Depression Inventory (DIKJ)", 'timeFrame': '1 month', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Connor Davidson Resilience Scale (CDRS)', 'timeFrame': '1 month', 'description': 'Differences in scores between cases and controls'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '1 month', 'description': 'Differences in scores between cases and controls'}], 'primaryOutcomes': [{'measure': 'n-3 fatty acid intake', 'timeFrame': '6 months', 'description': 'Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire'}, {'measure': 'n-3 fatty acid status', 'timeFrame': '1 day', 'description': 'Measurement of relative amount of n-3 fatty acids'}, {'measure': 'Pediatric depressive symptoms', 'timeFrame': '2 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Fatty acid metabolism', 'timeFrame': '1 day', 'description': 'Measurement of lipid mediators'}, {'measure': 'Biomarkers related to brain health', 'timeFrame': '1 day', 'description': 'Measurement of brain-derived neurotrophic factor (BDNF), kynurenine pathway metabolites, and monoamine neurotransmitters'}, {'measure': 'Biomarkers related to systemic inflammation', 'timeFrame': '1 day', 'description': 'Measurement of C-reactive Protein (CRP), alpha-1-acid glycoprotein, and cytokines'}, {'measure': 'Biomarkers related to gut microbiota', 'timeFrame': '1 day', 'description': 'Measurement of\n\n* gut microbiome composition with 16S rRNA sequencing\n* Faecal calprotectin\n* Intestinal fatty acid binding protein'}, {'measure': 'Biomarkers related to nutritional status', 'timeFrame': '1 day', 'description': 'Measurement of iron and iodine status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['n-3 fatty acids', 'pediatric Major Depressive Disorder'], 'conditions': ['Major Depressive Disorder', 'Depression', 'Child Mental Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': "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.\n\nPrimary objectives of this project are:\n\n1. To determine the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD.\n2. 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).\n\nParticipants meeting the following criteria are eligible for the study:\n\nInclusion criteria:\n\n* Participants of female and male sex\n* Children aged 8 to ≤ 13 years or teenagers 13 to \\< 18 years at time of study entry\n* Written informed assent of the subject and written informed consent from the subject's parents/legal representatives\n* No present primary diagnosed psychiatric disorder according to the M.I.N.I. KID Test\n\nExclusion criteria:\n\n* More than 4 weeks of regular n-3 FA supplementation\n* Women who are self-reported pregnant or breast feeding\n* Pre-existing neurological or medical conditions likely to be a risk factor for developing depressive symptoms\n\nIn a first step participants will be screened for in- and exclusion criteria. If participants can be included into the study we will\n\n* Measure participant's mental health with behavioural and cognitive assessments\n* Collect biological samples from participants (blood, urine, saliva, hair, and stool)\n\nThis study aims to recruit a total of 200 participants: 100 cases (from IICT) and 100 controls (recruited for this study).\n\nThere will be a total recruiting period of 18 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children/adolescents in German speaking Switzerland', 'healthyVolunteers': True, 'eligibilityCriteria': "For cases: participants enrolled in the IICT and therefore meeting the criterie for participation in the IICT will be selected.\n\nFor controls, participants fulfilling all of the following inlclusion criterie are eligible for the study\n\nInclusion Criteria:\n\n* Participants of female and male sex\n* Children aged 8 to ≤ 13 years or teenagers 13 to \\< 18 years at time of study entry\n* Written informed assent of the subject (appendix informed consent forms) and written in formed consent form from the subjects' parents/legal representatives\n* No present primary diagnosed psychiatric disorder according to the M.I.N.I. KID Test.\n* No use of chronic medication\n* Able to communicate in German; degree of understanding sufficient to comply with trial procedure\n\nExclusion Criteria:\n\n* 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.\n* Women who are self-reported pregnant or breast feeding.\n* 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\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant."}, 'identificationModule': {'nctId': 'NCT04158869', 'briefTitle': 'An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study', 'orgStudyIdInfo': {'id': 'n-3 case-control study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients with pMDD, enrolled in the Investigator-initiated clinical trial IICT (ClinicalTrials.gov Identifier: NCT03167307)'}, {'label': 'Controls', 'description': 'Controls matched to cases according to age, sex and school education'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8092', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'ETH Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Gregor Berger, Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Psychiatrische Universitätsklinik Zürich'}, {'name': 'Jeannine Baumgartner, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Federal Institute of Technology'}, {'name': 'Isabelle Herter-Aeberli, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Federal Institute of Technology'}, {'name': 'Michael B Zimmermann, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Federal Institute of Technology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'upon study completion of the IICT and the add-on study.', 'ipdSharing': 'YES', '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Psychiatric University Hospital, Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}