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

Major Depression Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acid as an Augmentor of Antidepressant Medication for Major Depression.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00289484
• Other study ID #: 05156
• Status: Recruiting
• Phase: Phase 2
• First received: February 7, 2006
• Last updated: September 11, 2006
• Start date: February 2006

Study information

• Verified date: September 2006
• Source: The University of New South Wales
• Contact: Catherine Owen, Bsc (hons)
• Phone: (02) 9382 3717
• Email: cath.owen[@]unsw.edu.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Omega-3 Polyunsaturated Fatty Acids

Locations

Country	Name	City	State
Australia	The University of New South Wales/Black Dog Institute	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
The University of New South Wales	Ocean Nutrition, Sphere Healthcare, Your Health Inc.

Country where clinical trial is conducted

Australia, 

References & Publications (2)

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. Review. Erratum in: Am J Psychiatry. 2006 Oct;163(10):1842. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change form pretreatment score on Depression Rating scale at 4 weeks
Secondary	Daily mood rating
Secondary	Weekly measure of depression
Secondary	Weekly measure of anxiety
Secondary	Weekly measure of functional status

External Links

•   Black Dog Institute website