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A Study of Omega-3 as an Augmentor of Antidepressant 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.
ClinicalTrials.gov Identifier: NCT00289484
Recruitment Status : Unknown
Verified September 2006 by The University of New South Wales.
Recruitment status was:  Recruiting
First Posted : February 9, 2006
Last Update Posted : September 13, 2006
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine whether augmentation of antidepressant medication with Omega-3 polyunsaturated fatty acids increases the speed and degree of improvement for patients with major depression

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

Detailed Description:
The study will be a 4 week, parallel-group double blind randomised control trial of the efficacy pf Omega-3 as an augmentor of antidepressant treatment for depression. People aged between 18 and 65 with a first or new episode of depression warranting treatment with antidepressant medication will be recruited. In addition to their antidepressant medication, participants will be randomly allocated to receive either Omega-3 (fish oil) or placebo (paraffin oil)for 4 weeks. Participants will commence treatment with the antidepressant and Omega-3/placebo simultaneously. Participants will be followed up at 1,3 and 4 weeks and will be asked to rate their mood daily for the 4 week study period. Blood samples will be taken pre and post treatment to measure change in Omega-3 levels.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 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 Acid as an Augmentor of Antidepressant Medication for Major Depression.
Study Start Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Change form pretreatment score on Depression Rating scale at 4 weeks

Secondary Outcome Measures :
  1. Daily mood rating
  2. Weekly measure of depression
  3. Weekly measure of anxiety
  4. Weekly measure of functional status

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participants must present with a first or new episode of DSM IV non-psychotic major depression warranting treatment with antidepressant mediation.
  • Must be able to give informed consent.

Exclusion Criteria:

  • 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.
  • History of allergy to Omega-3 supplements, finfish or shellfish.
  • Pregnancy, breast feeding or plans 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 due to theoretical bleeding risk.
  • Patients who, in the investigator's judgment pose a current serious suicidal or other safety risk, or patients who will not likely be able to comply with the study protocol.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00289484

Contact: Catherine Owen, Bsc (hons) (02) 9382 3717 cath.owen@unsw.edu.au

Australia, New South Wales
The University of New South Wales/Black Dog Institute Recruiting
Sydney, New South Wales, Australia, 2031
Sub-Investigator: Anne-Marie Rees, BSc MBBS         
Principal Investigator: Gordon B Parker, Dsc MD PhD         
Sub-Investigator: Catherine Owen, Bsc (hons)         
Sub-Investigator: Lucy Tully, BA (hons)         
Sub-Investigator: Heather Brotchie, MBBS         
Sponsors and Collaborators
The University of New South Wales
Your Health Inc.
Sphere Healthcare
Ocean Nutrition
Principal Investigator: Gordon B Parker, Dsc MD PhD Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute
More Information

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, 2006).

ClinicalTrials.gov Identifier: NCT00289484     History of Changes
Other Study ID Numbers: 05156
First Posted: February 9, 2006    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:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs