The Omega-3 Fatty Acid Paediatric Depression Trial
NCT03167307 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257
Last updated 2023-04-06
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.
Conditions
Interventions
- DRUG
-
Omega 3 fatty acid
Omega-3 fatty acids in addition to standard treatment for depression in children and adolescents according to the German S3 Guidelines
- DRUG
-
Placebo oil
medium chain triglycerides in addition to standard treatment for depression in children and adolescents according to the German S3 Guidelines
Sponsors & Collaborators
-
Swiss National Science Foundation
collaborator OTHER -
Gregor Berger
lead OTHER
Principal Investigators
-
Susanne Walitza, MD · Psychiatrische Universitätsklinik Zürich KJPP
-
Klaus Schmeck, MD · Universitäre Psychiatrische Kliniken (UPK) Basel
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-28
- Primary Completion
- 2022-03-24
- Completion
- 2022-03-24
Countries
- Switzerland
Study Locations
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