Back to resultsA Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression
Primary Purpose
Major Depression
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Omega-3 Polyunsaturated Fatty Acids
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Mood disorder
Eligibility 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.
Sites / Locations
- The University of New South Wales/Black Dog InstituteRecruiting
Outcomes
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
Full Information
NCT ID
NCT00289484
First Posted
February 7, 2006
Last Updated
September 11, 2006
Sponsor
The University of New South Wales
Collaborators
Your Health Inc., Sphere Healthcare, Ocean Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT00289484
Brief Title
A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression
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 Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The University of New South Wales
Collaborators
Your Health Inc., Sphere Healthcare, Ocean Nutrition
4. Oversight
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Mood disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
52 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Omega-3 Polyunsaturated Fatty Acids
Primary Outcome Measure Information:
Title
Change form pretreatment score on Depression Rating scale at 4 weeks
Secondary Outcome Measure Information:
Title
Daily mood rating
Title
Weekly measure of depression
Title
Weekly measure of anxiety
Title
Weekly measure of functional status
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Owen, Bsc (hons)
Phone
(02) 9382 3717
Email
cath.owen@unsw.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon B Parker, Dsc MD PhD
Organizational Affiliation
Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of New South Wales/Black Dog Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Rees, BSc MBBS
First Name & Middle Initial & Last Name & Degree
Gordon B Parker, Dsc MD PhD
First Name & Middle Initial & Last Name & Degree
Catherine Owen, Bsc (hons)
First Name & Middle Initial & Last Name & Degree
Lucy Tully, BA (hons)
First Name & Middle Initial & Last Name & Degree
Heather Brotchie, MBBS
12. IPD Sharing Statement
Citations:
PubMed Identifier
15777365
Citation
Rees AM, Austin MP, Parker G. Role of omega-3 fatty acids as a treatment for depression in the perinatal period. Aust N Z J Psychiatry. 2005 Apr;39(4):274-80. doi: 10.1080/j.1440-1614.2005.01565.x.
Results Reference
background
PubMed Identifier
16741195
Citation
Parker G, Gibson NA, Brotchie H, Heruc G, Rees AM, Hadzi-Pavlovic D. Omega-3 fatty acids and mood disorders. Am J Psychiatry. 2006 Jun;163(6):969-78. doi: 10.1176/ajp.2006.163.6.969. Erratum In: Am J Psychiatry. 2006 Oct;163(10):1842.
Results Reference
background
PubMed Identifier
34817851
Citation
Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
Results Reference
derived
Links:
URL
http://www.blackdoginstitute.org.au
Description
Black Dog Institute website
Learn more about this trial
A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression
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