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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by The University of New South Wales.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Your Health
Sphere Healthcare
Ocean Nutrition
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00238758
First received: October 11, 2005
Last updated: September 11, 2006
Last verified: September 2006
  Purpose

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


Condition Intervention Phase
Major Depression
Dysthymia
Drug: Omega-3 Polyunsaturated Fatty Acids
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

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

Secondary Outcome Measures:
  • Weekly measure of depressive symptoms
  • Weekly measure of anxiety symptoms
  • Weekly measure of functional status

Estimated Enrollment: 128
Study Start Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238758

Contacts
Contact: Catherine Owen, Bsc (hons) + 61 2 9382 4521 omega3study@unsw.edu.au

Locations
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    omega3study@unsw.edu.au   
Sponsors and Collaborators
The University of New South Wales
Your Health
Sphere Healthcare
Ocean Nutrition
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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00238758     History of Changes
Other Study ID Numbers: 05157
Study First Received: October 11, 2005
Last Updated: September 11, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:
Mood Disorder

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 16, 2014