Major Depressive DisorderNCT04158869
An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents
An observational study of Major Depressive Disorder and Depression, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Depression, Child Mental Disorder
- How many people
- 190 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Sep 2019to 22 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children/adolescents in German speaking Switzerland
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study
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.
Read the 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:
- To determine the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD.
- 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.
- Conditions
- Major Depressive Disorder, Depression, Child Mental Disorder
- Keywords
- n-3 fatty acids, pediatric Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Depression, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
n-3 fatty acid intake
Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire
Measured: 6 months
n-3 fatty acid status
Measurement of relative amount of n-3 fatty acids
Measured: 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
Measured: 2 weeks
Secondary outcomes (5)
Fatty acid metabolism
Measurement of lipid mediators
Measured: 1 day
Biomarkers related to brain health
Measurement of brain-derived neurotrophic factor (BDNF), kynurenine pathway metabolites, and monoamine neurotransmitters
Measured: 1 day
Biomarkers related to systemic inflammation
Measurement of C-reactive Protein (CRP), alpha-1-acid glycoprotein, and cytokines
Measured: 1 day
Biomarkers related to gut microbiota
Measurement of
- gut microbiome composition with 16S rRNA sequencing
- Faecal calprotectin
- Intestinal fatty acid binding protein
Measured: 1 day
Biomarkers related to nutritional status
Measurement of iron and iodine status
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start16 Sep 2019
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich
- Responsible party
- Sponsor
- Investigators
- Gregor Berger, Dr. med., Study chair, Psychiatrische Universitätsklinik ZürichJeannine Baumgartner, Dr., Principal investigator, Swiss Federal Institute of TechnologyIsabelle Herter-Aeberli, Dr., Principal investigator, Swiss Federal Institute of TechnologyMichael B Zimmermann, Dr. med., Principal investigator, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158869
- Sponsor's protocol ID
- n-3 case-control study
- Status last verified
- Jan 2022
- First submitted
- 18 Apr 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents: A Case-control Study
- ClinicalTrials.gov ID
- NCT04158869
- Acronym / sponsor ID
- n-3 case-control study
- Conditions
- Major Depressive Disorder, Depression, Child Mental Disorder
- Keywords
- n-3 fatty acids, pediatric Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To determine the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children/adolescents in German speaking Switzerland
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
n-3 fatty acid intake
Time frame: 6 months
Estimation of dietary omega-3 intake with a validated self-reported Omega-3 Food Questionnaire
n-3 fatty acid status
Time frame: 1 day
Measurement of relative amount of n-3 fatty acids
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
5 secondary outcomes
Fatty acid metabolism
Time frame: 1 day
Biomarkers related to brain health
Time frame: 1 day
Biomarkers related to systemic inflammation
Time frame: 1 day
Biomarkers related to gut microbiota
Time frame: 1 day
Biomarkers related to nutritional status
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregor Berger, Dr. med. study chair
Psychiatrische Universitätsklinik Zürich
Jeannine Baumgartner, Dr. principal investigator
Swiss Federal Institute of Technology
Isabelle Herter-Aeberli, Dr. principal investigator
Swiss Federal Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Depression, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
n-3 fatty acid intake (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.