Clinical trial NCT00238758: A Study of Omega-3 as a Treatment for Major Depression
Official title: A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Major Depression
Dysthymia
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: 2005-10-13
Enrollment: 128
Sex: ALL
Minimum age (years): 21
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 omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from pretreatment score on Depression Rating Scale at 6 weeks.
Secondary outcomes:
measure: Weekly measure of depressive symptoms
measure: Weekly measure of anxiety symptoms
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: Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute
name: Anne Marie Rees, BSc MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, School of Psychiatry UNSW and Executive Director, Black Dog Institute
name: Gordon B Parker, Dsc MD PhD
role: STUDY_DIRECTOR
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.