The Omega-3 Fatty Acid Paediatric Depression Trial

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gregor Berger
• Collaborator: Swiss National Science Foundation

Criteria

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