Clinical trial NCT00289484: A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression
Official title: A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acid as an Augmentor of Antidepressant Medication for Major Depression.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Major Depression
Keywords: Mood disorder
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Your Health Inc.
name: Sphere Healthcare
name: Ocean Nutrition
First posted: 2006-02-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change form pretreatment score on Depression Rating scale at 4 weeks
Secondary outcomes:
measure: Daily mood rating
measure: Weekly measure of depression
measure: Weekly measure of anxiety
measure: Weekly measure of functional status
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The University of New South Wales/Black Dog Institute
state: New South Wales
Study officials:
affiliation: Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute
name: Gordon B Parker, Dsc MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1080/j.1440-1614.2005.01565.x.
citation: 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.
citation: 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.