Status:
UNKNOWN
A Study of Omega-3 as a Treatment for Major Depression
Lead Sponsor:
The University of New South Wales
Collaborating Sponsors:
Your Health Inc.
Sphere Healthcare
Conditions:
Major Depression
Dysthymia
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00238758
Start Date
October 1 2005
Last Update
September 13 2006
Active Locations (1)
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1
The University of New South Wales/ Black Dog Institute
Sydney, New South Wales, Australia, 2031