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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Study of Omega-3 as a Treatment for Major Depression
Scientific title
A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 0 0
Dysthymia 0 0
Condition category
Condition code
Mental Health 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Omega-3 Polyunsaturated Fatty Acids

Treatment: Drugs: Omega-3 Polyunsaturated Fatty Acids

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Change from pretreatment score on Depression Rating Scale at 6 weeks.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Weekly measure of depressive symptoms
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Weekly measure of anxiety symptoms
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Weekly measure of functional status
Timepoint [3] 0 0

Key inclusion criteria
- Must meet DSM IV criteria for non-psychotic major depression lasting at least 6 weeks
or dysthymia.

- Must be under the care of a mental health practitioner.

- Must be able to give informed consent.

- Must be able to attend the Black Dog Institute.
Minimum age
21 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically
adequate doses and duration.

- History of psychosis or mania/hypomania or personality disorder.

- Non-English speaking or otherwise unable to provide historical information.

- Having taken Omega-3 dietary supplements in the last 3 months.

- Taking antidepressant medication for depression.

- History of allergy to n-3 PUFA supplements, finfish or shellfish.

- Pregnancy, breast feeding or planning to become pregnant during course of study.

- Post-natal depression.

- Current drug or alcohol abuse or dependence or history of abuse or dependence over the
last 12 months.

- Unstable thyroid function

- Hepatic or renal impairment or other medical conditions that may interfere with the
absorption and metabolism of omega-3 polyunsaturated fatty acids.

- Coagulopathy or anticoagulant treatment.

- Patients who, in the investigator's judgment pose a current serious suicidal or other
safety risk, or patients who are not likely to be able to comply with the study

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The University of New South Wales/ Black Dog Institute - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
The University of New South Wales
Other collaborator category [1] 0 0
Name [1] 0 0
Your Health Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Sphere Healthcare
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Ocean Nutrition
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Brief summary
The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are
effective as a monotherapy for depression.
Trial website
Trial related presentations / publications
Rees AM, Austin MP, Parker G. Role of omega-3 fatty acids as a treatment for depression in the perinatal period. Aust N Z J Psychiatry. 2005 Apr;39(4):274-80. Review.
Parker, G., Gibson, N., Brotchie, H., Heruc, G., Rees, A-M., Hadzi-Pavlovic, D. Omega-3 Fatty Acids and Mood Disorders. American Journal of Psychiatry(In press, 2005).
Public notes

Principal investigator
Name 0 0
Anne Marie Rees, BSc MBBS
Address 0 0
Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Catherine Owen, Bsc (hons)
Address 0 0
Country 0 0
Phone 0 0
+ 61 2 9382 4521
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see