At a glance
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OMEGA-3 FATTY ACIDS AS FIRST-LINE TREATMENT IN PAEDIATRIC DEPRESSION. A Phase III, 36-week, Multi-centre, Double-blind, Placebo-controlled Randomized Superiority Study
In Brief
A Phase 3 clinical trial evaluating Omega 3 fatty acid and Placebo oil for Depression. Completed, enrolled 257 participants across 7 sites.
Detailed Summary
This study investigates the therapeutic efficacy and safety of omega-3 fatty acids rich in eicosapentaenoic acid / docosahexaenoic acid in pediatric depression in a nine months double-blind multi-centre study in 220 children and adolescents between 8 and 17 years of age. Inflammatory and bioactive lipid markers as predictors of response are evaluated. The relationship between omega-3 fatty acids with psychopathology, illness course and cognitive parameters will be further investigated.
Study Details
Timeline
Interventions
Omega-3 fatty acids in addition to standard treatment for depression in children and adolescents according to the German S3 Guidelines
medium chain triglycerides in addition to standard treatment for depression in children and adolescents according to the German S3 Guidelines