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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04158869
Other study ID # n-3 case-control study
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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