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

SNF 33IC30_166826

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.

2017-04-28

2022-03-24

2022-03-24

Completed

Early phase I

257

Inclusion Criteria: * Male or female in- or outpatients of a participating centre * Children aged 8 \<13 years or teenager aged 13 to \< 18 years * Major depressive disorder with depressive symptoms of at least moderate severity * Written informed consent of the parents / legal representatives and patients' assent Exclusion Criteria: * contraindications to the drug * more than 4 weeks of regular omega-3 supplementation * pregnant or breastfeeding or intention to become pregnant * pre-existing neurological or medical conditions likely to be responsible for depressive symptoms * laboratory screening values considered clinically relevant * known or suspected non-compliance * other psychiatric diagnoses (substance dependency, schizophrenia, bipolar affective disorder, eating disorder, mental retardation, pervasive developmental disorder) * inability to follow the procedures of the study * Participation in another study with omega-3, previous enrolment in the current study, or dependent persons of the investigators

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2023-04-06