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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238758
Recruitment Status : Unknown
Verified September 2006 by The University of New South Wales.
Recruitment status was:  Recruiting
First Posted : October 13, 2005
Last Update Posted : September 13, 2006
Your Health Inc.
Sphere Healthcare
Ocean Nutrition
Information provided by:
The University of New South Wales

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

Condition or disease Intervention/treatment Phase
Major Depression Dysthymia Drug: Omega-3 Polyunsaturated Fatty Acids Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression
Study Start Date : October 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from pretreatment score on Depression Rating Scale at 6 weeks.

Secondary Outcome Measures :
  1. Weekly measure of depressive symptoms
  2. Weekly measure of anxiety symptoms
  3. Weekly measure of functional status

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238758

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Contact: Catherine Owen, Bsc (hons) + 61 2 9382 4521

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Australia, New South Wales
The University of New South Wales/ Black Dog Institute Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Catherine Owen, Bsc (hons)    02 9382 4521   
Sponsors and Collaborators
The University of New South Wales
Your Health Inc.
Sphere Healthcare
Ocean Nutrition
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Principal Investigator: Anne Marie Rees, BSc MBBS Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute
Study Director: Gordon B Parker, Dsc MD PhD Professor, School of Psychiatry UNSW and Executive Director, Black Dog Institute
Additional Information:
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).

Layout table for additonal information Identifier: NCT00238758    
Other Study ID Numbers: 05157
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: September 13, 2006
Last Verified: September 2006
Keywords provided by The University of New South Wales:
Mood Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders