The Omega-3 Fatty Acid Paediatric Depression Trial

NCT03167307 | Completed Phase 3 DMC

• 2 other identifiers: SNF 33IC30_1668262016-02116
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 7

Brief 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

Depression

Keywords

omega-3 fatty acids; eicosapentaenoic acid; docosahexaenoic acid; antidepressants; suicidality; cognition; childhood depression; pediatric depression

Outcome Measures

Primary Outcomes (1)

• Symptomatic improvement

  Change of the (continuous) Children's Depression Rating Scale-revised (CDRS-R) total score analyzed using using a linear random coefficient regression model

  9 months

Secondary Outcomes (16)

• Response rate

  6 weeks

• Remission rate

  9 months

• Scale of Impulsivity and Emotion Dysregulation (IES-27)

  9 months

• Antidepressant medication

  9 months

• Children's global assessment scale (CGAS)

  9 months

Other Outcomes (7)

• Verbal learning and memory test (VLMT)

  9 months

• Behavior Rating Inventory of Executive Function (BRIEF)

  9 months

• Tolerability assessed by the Self-reported Antidepressant Side-Effect Checklist (ASEC)

  9 months

Study Arms (2)

Omega-3 fatty acid oil

EXPERIMENTAL

A daily dose of 500mg EPA/ 250mg DHA in the 8 to \<13 year olds, and 1000mg EPA / 500mg DHA in the 13 to \<18 years olds, respectively, will be added to standardized treatment according to the German S3 Guidelines for the treatment of depression in children and adolescents

Drug: Omega 3 fatty acid

Placebo oil

PLACEBO COMPARATOR

Placebo capsules will contain mostly medium chain triglycerides (MCT) and also a small amount of fish oil to mimic the fishy flavour and taste. Placebo will be added to standardized treatment according to the German S3 Guidelines for the treatment of depression in children and adolescents

Drug: Placebo oil

Interventions

Omega 3 fatty acid DRUG

Omega-3 fatty acids in addition to standard treatment for depression in children and adolescents according to the German S3 Guidelines

Also known as: Eicosapentaenoic acid (EPA) / docosahexaenoic acid (DHA)

Omega-3 fatty acid oil

Placebo oil DRUG

medium chain triglycerides in addition to standard treatment for depression in children and adolescents according to the German S3 Guidelines

Also known as: medium chain triglycerides

Placebo oil

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gregor Berger: lead
• Swiss National Science Foundation: collaborator

Study Sites (7)

Psychiatric Services Baselland

Liestal, Basel-Landschaft, Switzerland

Location

Psychiatric University Clinics, Department of Child and Adolescent Psychiatry

Zurich, Canton of Zurich, 8032, Switzerland

Location

Klinik Sonnenhof

Ganterschwil, St.Gallen, Switzerland

Location

Clienia Littenheid

Littenheid, Thurgau, Switzerland

Location

Spital Thurgau Kinder- und Jugendpsychiatrischer Dienst

Weinfelden, Thurgau, Switzerland

Location

University Psychiatric Services

Basel, Switzerland

Location

Stiftung Kinder- und Jugendpsychiatrische Dienste St.Gallen

Sankt Gallen, Switzerland

Location

Related Publications (5)

• Berger G, Haberling I, Emery S, Albermann M, Baumgartner N, Nalani K, Strumberger M, Wockel L, Erb S, Bachmann S, Muller-Knapp U, Contin-Waldvogel B, Yamini A, Rhiner B, Drechsler R, Held U, Reeve K, Heinz P, Pauli D, Schmeck K, Hersberger M, Walitza S; Omega-3 pMDD Study Group. omega-3 Fatty Acids in Pediatric Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2548703. doi: 10.1001/jamanetworkopen.2025.48703.

  PMID: 41481294 DERIVED

• Preisig M, Haberling I, Smigielski L, Emery S, Baumgartner N, Albermann M, Strumberger M, Schmeck K, Wockel L, Erb S, Rhiner B, Contin-Waldvogel B, Walitza S, Berger G. The mediating role of depression in the association between health-related quality of life and suicidal ideation in adolescents: findings from a longitudinal study. Front Child Adolesc Psychiatry. 2025 Aug 14;4:1567387. doi: 10.3389/frcha.2025.1567387. eCollection 2025.

  PMID: 40894517 DERIVED

• Haberling I, Preisig M, Emery S, Baumgartner N, Albermann M, Strumberger M, Schmeck K, Wockel L, Erb S, Rhiner B, Contin B, Walitza S, Berger G. Clinical characteristics of depressed children and adolescents with and without suicidal thoughts and behavior: a cross-sectional study. Front Child Adolesc Psychiatry. 2025 Feb 21;4:1510961. doi: 10.3389/frcha.2025.1510961. eCollection 2025.

  PMID: 40061518 DERIVED

• Albermann M, Emery S, Baumgartner N, Strumberger M, Erb S, Wockel L, Muller-Knapp U, Rhiner B, Contin-Waldvogel B, Bachmann S, Schmeck K, Berger G; Omega-3 Study Team; Haberling I. Executive functions and borderline personality features in adolescents with major depressive disorder. Front Hum Neurosci. 2023 Jun 22;17:957753. doi: 10.3389/fnhum.2023.957753. eCollection 2023.

  PMID: 37425294 DERIVED

• Haberling I, Berger G, Schmeck K, Held U, Walitza S. Omega-3 Fatty Acids as a Treatment for Pediatric Depression. A Phase III, 36 Weeks, Multi-Center, Double-Blind, Placebo-Controlled Randomized Superiority Study. Front Psychiatry. 2019 Nov 27;10:863. doi: 10.3389/fpsyt.2019.00863. eCollection 2019.

  PMID: 31827448 DERIVED

Related Links

• Study website (online from Mai 2017)

MeSH Terms

Conditions

Depression; Suicidal Ideation

Interventions

Fatty Acids, Omega-3; Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Eicosanoids

Study Officials

• Susanne Walitza, MD

  Psychiatrische Universitätsklinik Zürich KJPP

  PRINCIPAL INVESTIGATOR

• Klaus Schmeck, MD

  Universitäre Psychiatrische Kliniken (UPK) Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo-controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Developmental Psychopharmacology Group, Department of Child and Adolescent Psychiatry

Model Details: A 36-week, multi-centre, double-blind, placebo-controlled randomized superiority Study.

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: May 25, 2017
• Study Start: April 28, 2017
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

CH (7)