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

September 11, 2006 updated by: The University of New South Wales

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
        • Recruiting
        • The University of New South Wales/ Black Dog Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from pretreatment score on Depression Rating Scale at 6 weeks.

Secondary Outcome Measures

Outcome Measure
Weekly measure of functional status
Weekly measure of depressive symptoms
Weekly measure of anxiety symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Collaborators

Ocean Nutrition
Your Health Inc.
Sphere Healthcare

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Registration Dates

First Submitted

October 11, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Estimate)

September 13, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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