MedPath

Treating Depression with Omega-3

Completed
Conditions
Major depression
Mental and Behavioural Disorders
Depressive episode
Registration Number
ISRCTN47431149
Lead Sponsor
niversity Hospital of Montreal (CHUM) Research Centre (Canada)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
432
Inclusion Criteria

1. Greater than 18 years of age, either sex
2. Current diagnosis of major depressive episode based on the Mini-International Neuropsychiatric Interview (MINI version 5.0.0)
3. Inventory of Depressive Symptomatology (IDS-SR) score greater or equal to 27
4. Presence of significant depressive symptoms for at least 4 weeks, as judged by the clinician
5. If on antidepressants, has been at maximum recommended tolerable dosage for greater than 4 weeks
6. If not on antidepressants, has been either intolerant to at least two previous trials of antidepressants or refuses to take an antidepressant despite medical advice
7. Provision of signed informed consent for participation

Exclusion Criteria

1. Known allergy to fish or sunflower oil
2. Known intolerance of fish oil supplements
3. Has taken greater than 28 capsules of fish oil supplements during the last 4 weeks
4. Current alcohol or drug abuse or dependency based on the MINI
5. Bipolar disorder based on the MINI
6. Significant suicidal risk based on clinical judgement
7. Pregnant women (all non-menopausal women will need to have a negative pregnancy test before randomisation) and those planning to become pregnant over the course of the trial, or women of child bearing potential not using an accepted method of contraception
8. With coagulation diseases and/or subjects regularly taking any drugs or herbs that thin the blood such as aspirin, heparin, clopidogrel, warfarin, dalteparin, dipyrdamole, enoxaparin, ticlopedine, and gingko
9. History of myocardial infarction
10. Pancreatic insufficiency
11. Investigator's judgement that the patient is unable/unwilling to comply with study regimen

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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