A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression

Phase 2

• Conditions: Major Depression

• Registration Number: NCT00289484
• Lead Sponsor: The University of New South Wales

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-11
• Last Update Posted: 2006-09-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change form pretreatment score on Depression Rating scale at 4 weeks

Secondary Outcome Measures

Name	Time	Method
Daily mood rating
Weekly measure of depression
Weekly measure of anxiety
Weekly measure of functional status

Trial Locations

Locations (1)

The University of New South Wales/Black Dog Institute; 🇦🇺 Sydney, New South Wales, Australia