Abstract
Background: The prevalence of mood disorders in children is a growing global concern. Omega-3 fatty acids (FA) are emerging as a promising adjuvant therapy for depressive disorder (DD) in paediatric patients. The primary objective of this pilot, single-centre, randomized, double-blind controlled study was to compare the efficacy of an Omega-3 FA fish oil emulsion with a control oil emulsion alongside standard treatment for depressive symptoms in children and adolescents suffering from depressive disorder (DD) and mixed anxiety depressive disorder (MADD).Methods: 38 children (12 patients were treated and diagnosed for at least 1 month before enrolment, 26 patients were first-time diagnosed as DD) aged 11–17 years were randomised 1:1 to the intervention (Omega-3 FA, 19 patients) or active comparator (Omega-6 FA, 19 patients) groups. Children’s depression inventory (CDI) ratings were performed at baseline, every 2 weeks for a 12-week intervention period and at 4-week post-intervention. 35 patients (17 in Omega-3 and 18 in Omega-6 groups) who completed the whole intervention period were evaluated. Patients from Omega-3 group were stratified according to diagnosis into two subgroups (DD—10/17 and mixed anxiety depressive disorder (MADD)—7/17 patients) and in the Omega-6 group into DD—10/18 and MADD—8/18 patients. Groups were evaluated separately. Differences between-groups were tested with the Student´sttest or non-parametric Mann–Whitney U test. Two-way ANOVA with repeated measures and Friedman test were used to analyse theTreatmenteffect for response in CDI score. p < 0.05 was considered significant in all statistical analyses.Results: Significant reductions in CDI scores in 35 analysed patients who completed 12 weeks intervention were observed after 12 weeks of intervention only in the Omega-3 group (p = 0.034). After stratification to depressive disorder and mixed anxiety depressive disorder subgroups, the DD subgroup receiving the Omega-3 FA fish oil showed statistically greater improvement (score reduction after 8 week treatment of −9.1 CDI, p = 0.0001) when compared to the MADD subgroup (score reduction after 8 week treatment −4.24 CDI, p = 0.271).Conclusions: CDI scores were reduced in the Omega-3 group and the depression subgroup had greater improvement than the mixed depressive/anxiety group. An Omega-3 fatty acid rich fish oil emulsion may be an effective adjuvant supplement during the treatment of depressive disorders in children.Trial registrationISRCTN81655012
Funding Information
  • Agentúra na Podporu Výskumu a Vývoja (15-0063)
  • Vedecká Grantová Agentúra MŠVVaŠ SR a SAV (01/0703/13)

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