The Omega-3 Fatty Acid Paediatric Depression Trial

NCT03167307 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2023-04-06

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03167307 on ClinicalTrials.gov