Condition category
Mental and Behavioural Disorders
Date applied
10/10/2016
Date assigned
19/10/2016
Last edited
19/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Mood disorders in children and adolescents are a serious problem worldwide, and are becoming more common in younger children. In recent years, research has been focused on the adjuvant therapy of depression (extra treatment to enhance the effects of the main treatment) with the aim of reducing the consumption of antidepressants, to prolong remission (disease-free periods) and improve the outlook for these patients. The use of Omega-3 fatty acids as an adjuvant therapy have been shown to be promising, with beneficial effects in the prevention and treatment of depression. The aim of this study is to assess the effectiveness of omega-3 fatty acids rich fish oil in the treatment of depression symptoms in children and adolescents treated for depression as well as to find out what effects this has on the body by looking at biochemical markers (substances).

Who can participate?
Children and adolescents aged 8–18 years suffering from depression who are registered at the Department of Child psychiatry of Comenius University and Child University Hospital in Bratislava.

What does the study involve?
Patients are randomly allocated to one of two groups. Those in the first group take 20 mL of omega-3 fish oil emulsion every day for 12 weeks in addition to their usual treatment, followed by 4 weeks of not taking the oil. Those in the second group take 20 mL of omega-6 sunflower oil emulsion every day for 12 weeks in addition to their usual treatment, followed by 4 weeks of not taking the oil. At the start of the study, every two weeks during the 12 week treatment period, and then at 16 weeks, participant have their symptoms of depression assessed and have blood and saliva samples taken to measure for chemical indicators of the effects the supplements are having on the body.

What are the possible benefits and risks of participating?
Participants who receive the omega 3 oil may benefit from a reduction of their depressive symptoms. There are no known risks involved with participating.

Where is the study run from?
1. Comenius University (Slovakia)
2. Comenius University and Child University Hospital (Slovakia)

Who is funding the study?
March 2013 to June 2020

How long will the trial be recruiting participants for?
Slovak Research and Development Agency (Slovakia)

Who is the main contact?
Professor Zdenka Durackova
zdenka.durackova@fmed.uniba.sk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zdeňka Ďuračková

ORCID ID

http://orcid.org/0000-0001-6956-7038

Contact details

Institute of Medical Chemistry
Biochemistry and Clinical Biochemistry
Faculty of Medicine
Comenius University
Bratislava
813 72
Slovakia
+421 1 59357 564
zdenka.durackova@fmed.uniba.sk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

APVV-15-0063

Study information

Scientific title

Molecular bases of depressive disorders in children and adolescents, effect of omega-3 fatty acids, inflammation and oxidative stress

Acronym

Depoxin

Study hypothesis

The aim of the current study is to compare the efficacy of 12 weeks administration of omega-3 fatty acids present in fish oil emulsion with a control oil emulsion (omega-6 fatty acids rich sunflower oil emulsion) alongside standard antidepressant treatment on depressive symptoms in children and adolescents (8 to 18 years old).

The study will investigate:
1. Clinical parameters: CDI score
2. Biochemical parameters: Lipid profile, fatty acid composition in serum LDL- and HDL-subfractions of lipoproteins, markers of oxidative stress and inflammation in blood, steroidal hormones in saliva
3. Biophysical parameters: Fluidity of erythrocyte membranes
4. The length of telomeres in the buccal cells

Ethics approval

Ethical Committee of the Child University Hospital and the Faculty of Medicine, Comenius University Bratislava, Slovakia, 20/03/2013

Study design

Single-centre randomized double-blind comparator controlled interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet in Slovakian

Condition

Depressive disorder (F32) or mixed anxiety and depressive disorder (F41.2)

Intervention

Patients are allocated in a 1:1 ratio to the two arms (Om3 and Om6) according to a computer-generated random sequence using block randomisation with a block-size of four. The randomisation was performed by the independent statistician. Patients are enrolled and assigned sequentially to adjuvant interventions by the physician. The allocation sequence is not available to any member of the research team until the databases had been completed and locked.

Intervention group: Participants receive 20ml of an omega-3 FA rich fish oil emulsion (Om3), which provides 2400 mg of total omega-3 FA; 1000 mg EPA and 750 mg DHA, EPA:DHA ratio = 1.33:1, for 12 weeks in addition to their standard antidepressant therapy, followed by a 4 week wash out period.

Control group: Participants receive an identically looking comparator omega-6 sunflower oil emulsion containing min 2467 mg of omega-6 linoleic acid provided by Cultech Ltd, Port Talbot (UK) for 12 weeks in addition to their standard antidepressant therapy, followed by a 4 week wash out period.

Clinical examinations take place at the beginning of the project (week 0), and every 2 weeks for 3 months (weeks 2, 4, 6, 8, 10, 12) and after following 4 week wash-out period, at week 16. Ratings aree made using the self rated scale Children's Depression Inventory (CDI). Biological samples (blood, urine, saliva) are taken at the week 0, 6, 12 and 16.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Clinical symptoms of depression are determined using Children's Depression Inventory score (CDI) at baseline, 2, 4, 6, 8, 10, 12 and 16 weeks.

Secondary outcome measures

1. Basic biochemical marker levels (glucose, uric acid, lipid profile (total cholesterol, LDL-CH, HDL-CH, TAG), creatinine, CRP, liver enzymes ALT, AST) are measured by testing blood samples taken at baseline, at the week 6 and 12 of intervention and after wash-out period, at the week 16
2. Markers of oxidative stress (antioxidant enzymes SOD, GPx, CAT in Er, PON1 in serum, markers of lipid damage - lipoperoxides, 8-IsoP, protein damage - AOPP, serum protein carbonyls, nitrotyrosine, DNA damage in lymphocytes by comet assay, total antioxidant status-TEAC) are measured by testing blood samples taken at baseline, at the week 6 and 12 of intervention and after wash-out period, at the week 16
3. Markers of inflammation (CRP, calprotectin, cytokines and eicosanoids, thromboxanes) are measured by testing blood samples taken at baseline, at the week 6 and 12 of intervention and after wash-out period, at the week 16
4. Hormones in saliva (cortisol, aldosteron) are measured by testing saliva samples taken at baseline, at the week 6 and 12 of intervention and after wash-out period, at the week 16
5. Erythrocyte (Er) membrane fluidity is measured by spectrofuorimeter at baseline, at the week 6 and 12 of intervention and after wash-out period, at the week 16
6. Composition and content of serum fatty acids (FA) are measured by gas chromatography at baseline, at the week 6, 12 of intervention and after wash-out period, at the week 16
8. Length of DNA telomers in buccal cells is measured by qPCR at baseline and at 12 week intervention

Overall trial start date

01/03/2013

Overall trial end date

30/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children and adolescents who met diagnostic criteria for depressive disorder or mixed anxiety and depressive disorder according to ICD 10
2. No signs of chronic somatic disease
3. Normal eating habits
4. Parents/guardian are willing to provide a signed informed consent
5. Children and adolescents are willing to provide the blood, urine and saliva samples

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60 = 30 in omega-3 group and 30 in omega-6 group

Participant exclusion criteria

1. Chronic somatic diseases (endocrine, metabolic, autoimmune)
2. Dietary restrictions (vegetarians, lactose intolerance, celiac disease)
3. Psychotic disorders
4. Eating disorders
5. Addiction to psychoactive compounds
6. Personality disorders
7. Organic mental disorders
8. Pervasive developmental disorders

Recruitment start date

01/03/2014

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Slovakia

Trial participating centre

Comenius University
Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry Faculty of Medicine Limbova 1
Bratislava
833 40
Slovakia

Trial participating centre

Comenius University and Child University Hospital
Department of Child and Adolescent Psychiatry Limbová 1
Bratislava
833 40
Slovakia

Sponsor information

Organisation

Comenius University

Sponsor details

Faculty of Medicine
Špitálska 24
Bratislava
813 72
Slovakia
+421 2 593 57 466
dekan.sekretariat@fmed.uniba.sk

Sponsor type

University/education

Website

https://www.fmed.uniba.sk/

Funders

Funder type

Research organisation

Funder name

Slovak Research and Development Agency (Agentúra na Podporu Výskumu a Vývoja)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journals of papers discussing:
1. Clinical symptoms – results of pilot study - 2017
2. Markers of oxidative stress – pilot results -2017
3. Markers of inflammation – pilot results 2018
4. Fluidity of membranes and fatty acid composition - 2019
5. Telomere length – 2019
6. Mutual relation between clinical symptoms and markers of oxidative stress and inflammation - 2020

IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be available upon request from zdenka.durackova@fmed.uniba.sk and jana.trebaticka@fmed.uniba.sk

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes