Status:
UNKNOWN
A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression
Lead Sponsor:
The University of New South Wales
Collaborating Sponsors:
Your Health Inc.
Sphere Healthcare
Conditions:
Major Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 maj...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00289484
Start Date
February 1 2006
Last Update
September 13 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of New South Wales/Black Dog Institute
Sydney, New South Wales, Australia, 2031