Overview
A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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 depressionPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The University of New South WalesCollaborators:
Ocean Nutrition
Sphere Healthcare
Your Health Inc.Treatments:
Antidepressive Agents
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.