A Study of Omega-3 as an Augmentor of Antidepressant 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 Acid as an Augmentor of Antidepressant Medication for Major Depression.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

52

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
        • 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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 form pretreatment score on Depression Rating scale at 4 weeks

Secondary Outcome Measures

Outcome Measure
Daily mood rating
Weekly measure of depression
Weekly measure of anxiety
Weekly measure of functional status

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: Gordon B Parker, Dsc MD PhD, Professor, School of Psychiatry UNSW and Exectutive 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

February 1, 2006

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 9, 2006

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

  • 05156

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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