Youth Depression Alleviation: A randomised controlled trial of omega-3 fatty acids (fish oil) for major depressive disorder in young people (YoDA-F)

Phase 3

Completed

• Conditions: Major depressive disorder; Mental Health - Depression; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12613001352796
• Lead Sponsor: Orygen Youth Health Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-11
• Study Completion: 2020-06-06
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

1) Aged 15-25 years help seeking for psychological distress.
2) A score between 11 and 20 on the QIDS-A17-C at first contact with the service AND after 1 week (plus 1-5 days if the client is unable to attend earlier) at the second assessment, or at 2 subsequent (weekly) follow-up assessments.
3) A diagnosis of major depressive disorder using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P).
4) Written informed consent (for individuals under 18, written informed consent of at least one parent or a guardian is required).

Exclusion Criteria

1) Lifetime diagnosis or history of treatment for psychotic disorder or bipolar disorder or substance dependence (assessed with a brief, self-developed checklist).
2) History of treatment with an antidepressant (more than four weeks during the last 12 months, upon review of medical history).
3) Acute suicidal behaviour as assessed by a score of 6 on the Comprehensive Assessment of At Risk Mental States (CAARMS; item 7.3) or aggressive behaviour (score of 6 on CAARMS item 5.4).
4) Depression secondary to a medical condition.
5) IQ<70 as per medical history review.
6) Pregnancy or lactation.
7) Laboratory values more than 15% outside the normal range for bleeding parameters.
8) Individuals who are taking omega-3 supplements or psychotropic medication, currently or within 8 weeks of being included in the trial, for more than 1 week continuously.
9) Known allergy to omega-3s or any ingredients in the investigational product.

Study & Design

• Study Type: Interventional
• Study Design: Not specified