Major Depression
Conditions
Keywords
Mood disorder
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.
Interventions
Sponsors
Your Health Inc.
Sphere Healthcare
Ocean Nutrition
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change form pretreatment score on Depression Rating scale at 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily mood rating | — |
| Weekly measure of depression | — |
| Weekly measure of anxiety | — |
| Weekly measure of functional status | — |
Countries
Australia
Contacts
Primary ContactCatherine Owen, Bsc (hons)
Outcome results
None listed