Back to resultsA Study of Omega-3 as a Treatment for Major Depression
Primary Purpose
Major Depression, Dysthymia
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: 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.
Sites / Locations
- The University of New South Wales/ Black Dog InstituteRecruiting
Outcomes
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
Full Information
NCT ID
NCT00238758
First Posted
October 11, 2005
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
NCT00238758
Brief Title
A Study of Omega-3 as a Treatment for Major Depression
Official Title
A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (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 omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Dysthymia
Keywords
Mood Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
128 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Omega-3 Polyunsaturated Fatty Acids
Primary Outcome Measure Information:
Title
Change from pretreatment score on Depression Rating Scale at 6 weeks.
Secondary Outcome Measure Information:
Title
Weekly measure of depressive symptoms
Title
Weekly measure of anxiety symptoms
Title
Weekly measure of functional status
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Owen, Bsc (hons)
Phone
+ 61 2 9382 4521
Email
omega3study@unsw.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marie Rees, BSc MBBS
Organizational Affiliation
Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordon B Parker, Dsc MD PhD
Organizational Affiliation
Professor, School of Psychiatry UNSW and Executive Director, Black Dog Institute
Official's Role
Study Director
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
Catherine Owen, Bsc (hons)
Phone
02 9382 4521
Email
omega3study@unsw.edu.au
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
Links:
URL
http://www.blackdoginstitute.org.au
Description
Black Dog Institute website
URL
http://psych.med.unsw.edu.au
Description
University of NSW, school of psychiatry website
Learn more about this trial
A Study of Omega-3 as a Treatment for Major Depression
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