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A Study of Omega-3 as a Treatment for Major Depression

NCT ID: NCT00238758

Last Updated: 2006-09-13

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

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.

Detailed Description

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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 currently on an antidepressant or planning to take an antidepressant in the next 14 weeks will be recruited. Participants will be randomly allocated to receive Omega-3 (fish oil) or placebo (paraffin oil) for 6 weeks. Participants will be followed up weekly and will be asked to rate their mood daily for the 6 week study period. Blood samples will be taken pre and post treatment to measure change in omega-3 levels. At the end of 6 weeks all participants will receive a further 8 weeks supply of omega-3.

Conditions

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Major Depression Dysthymia

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

* 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 Criteria

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Your Health Inc.

OTHER

Sponsor Role collaborator

Sphere Healthcare

INDUSTRY

Sponsor Role collaborator

Ocean Nutrition

INDUSTRY

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role lead

Principal Investigators

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Anne Marie Rees, BSc MBBS

Role: PRINCIPAL_INVESTIGATOR

Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute

Gordon B Parker, Dsc MD PhD

Role: STUDY_DIRECTOR

Professor, School of Psychiatry UNSW and Executive 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: + 61 2 9382 4521

Email: [email protected]

Facility Contacts

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Catherine Owen, Bsc (hons)

Role: primary

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)

Related Links

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http://www.blackdoginstitute.org.au

Black Dog Institute website

http://psych.med.unsw.edu.au

University of NSW, school of psychiatry website

Other Identifiers

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05157

Identifier Type: -

Identifier Source: org_study_id