A Study of Omega-3 as an Augmentor of Antidepressant 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:
NCT00289484
First received: February 7, 2006
Last updated: September 11, 2006
Last verified: September 2006
  Purpose

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 Intervention Phase
Major Depression
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 Acid as an Augmentor of Antidepressant Medication for Major Depression.

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Daily mood rating
  • Weekly measure of depression
  • Weekly measure of anxiety
  • Weekly measure of functional status

Estimated Enrollment: 52
Study Start Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00289484

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

Locations
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
Sphere Healthcare
Ocean Nutrition
Investigators
Principal Investigator: Gordon B Parker, Dsc MD PhD Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00289484     History of Changes
Other Study ID Numbers: 05156
Study First Received: February 7, 2006
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:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014