Skip to content

Molecular basis of depression disorder and influence of omega-3 fatty acid on clinical symptoms and biomarkers

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81655012
Enrollment
60
Registered
2016-10-19
Start date
2014-03-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 perform
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 ide

Sponsors

Comenius University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

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/guardians are willing to provide a signed informed consent 5. Children and adolescents are willing to provide blood, urine and saliva samples

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Slovakia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 15, 2026