Data

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

Orygen

Dataset description

This project tested the effectiveness of a 12-week parallel group, double-blind, randomized, placebo-controlled trial of 1.4 g day(-1) omega-3 PUFAs in help seeking 15- to 25-year-olds (N = 400) presenting with major depressive disorder.
Click to explore relationships graph

Source Study

Purpose

Treatment

Phase

Phase 3

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

A/Prof G Paul Amminger, MD, PhD, FRANZCP

Brief Summary

Long-chain omega-3 polyunsaturated fatty acids (PUFAs) play an important role in a range of physiological processes in all living organisms. Supplementation with omega-3 PUFAs has been shown to have range of beneficial effects on both physical and mental health, while results of previous trials in child and adult populations suggest that omega-3 PUFAs may offer a safe and effective treatment for depression. However, conclusions from these trials have been limited by their relatively small sample ....
Read more

Key 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 in ....
Read more

Key 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 seco ....
Read more

Can healthy volunteers participate?

No

 

Population

Sample Size    233

Min. age    15 Years

Max. age    25 Years

Sex    Both males and females

Condition category    Major depressive disorder

Condition code    Alternative and Complementary Medicine , Mental Health

Intervention

Intervention code Behaviour , Treatment: Other

Participants will receive either long-chain omega-3 fatty acids or placebo for 12 weeks. All participants will receive cognitive behavioural case management (CBCM). Long-chain omega-3 fatty acids / placebo treatment will commence at week 0. CBCM sessions will commence at approximately week 2. Cognitive behavioural case management (CBCM): Participants are expected to receive 5 sessions of CBCM. The CBCM intervention consists of cognitive-behavioural therapy (CBT) embedded within case management. ....
Read more

Comparison

Control group Placebo

Placebo: The placebo are capsules matched in appearance and taste to the active treatment. Placebo capsules contain paraffin oil, chosen as it does not contain polyunsaturated fatty acids and has no impact on omega-3 fatty acid metabolism. To ensure blinding, placebo capsules will be carefully matched in appearance and flavour with the active treatment; they will also contain the same amount of Vitamin E as the fish oil capsules, and approximately 1% fish oil to mimic taste.

Outcomes

Outcome: Change in depressive symptoms at end of oral intervention phase (12 weeks), as assessed by the 17-item clinician-rated Quick Inventory of Depression Symptoms - Adolescent Version (QIDS-A17-C).
Timepoint: Change in QIDS-A17-C scores, between baseline and 12 weeks or the time point when a subject exits the study.

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All individual participant data after de-identification

When will data be available?

Data are available immediately for an indefinite time

Available to whom?

Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy.

Available for what types of analyses?

To any type of analyses. Assessed on a case-by-case basis.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au