A Study of Omega-3 as a Treatment for Major Depression

Major Depression Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00238758
• Other study ID #: 05157
• Status: Recruiting
• Phase: Phase 2
• First received: October 11, 2005
• Last updated: September 11, 2006
• Start date: October 2005

Study information

• Verified date: September 2006
• Source: The University of New South Wales
• Contact: Catherine Owen, Bsc (hons)
• Phone: + 61 2 9382 4521
• Email: omega3study[@]unsw.edu.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.

Description:

The study will be a 6 week, parallel-group, double-blind randomized controlled trial of the efficacy of Omega-3 as a monotherapy for depression. People aged 21-65 who have major depression but are not currently on an antidepressant or planning to take an antidepressant in the next 14 weeks will be recruited. Participants will be randomly allocated to receive Omega-3 (fish oil) or placebo (paraffin oil) for 6 weeks. Participants will be followed up weekly and will be asked to rate their mood daily for the 6 week study period. Blood samples will be taken pre and post treatment to measure change in omega-3 levels. At the end of 6 weeks all participants will receive a further 8 weeks supply of omega-3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

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 protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Dysthymia
• Major Depression

Intervention

Drug:
• Omega-3 Polyunsaturated Fatty Acids

Locations

Country	Name	City	State
Australia	The University of New South Wales/ Black Dog Institute	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
The University of New South Wales	Ocean Nutrition, Sphere Healthcare, Your Health Inc.

Country where clinical trial is conducted

Australia, 

References & Publications (2)

Parker G, Gibson NA, Brotchie H, Heruc G, Rees AM, Hadzi-Pavlovic D. Omega-3 fatty acids and mood disorders. Am J Psychiatry. 2006 Jun;163(6):969-78. Review. Erratum in: Am J Psychiatry. 2006 Oct;163(10):1842. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from pretreatment score on Depression Rating Scale at 6 weeks.
Secondary	Weekly measure of depressive symptoms
Secondary	Weekly measure of anxiety symptoms
Secondary	Weekly measure of functional status

External Links

•   Black Dog Institute website
•   University of NSW, school of psychiatry website