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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Major Depression

Keywords

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Mood disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Omega-3 Polyunsaturated Fatty Acids

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gordon B Parker, Dsc MD PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute

Locations

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The University of New South Wales/Black Dog Institute

Sydney, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Catherine Owen, Bsc (hons)

Role: CONTACT

Phone: (02) 9382 3717

Email: [email protected]

References

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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.

Reference Type BACKGROUND

PMID: 15777365 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16741195 (View on PubMed)

Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.

Reference Type DERIVED

PMID: 34817851 (View on PubMed)

Other Identifiers

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05156

Identifier Type: -

Identifier Source: org_study_id