Major depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
Participants are randomly assigned to take three capsules per day of 500 mg of omega-3 fish oil supplement or a matched sunflower oil placebo (low in omega-3 and omega-6) for 8 weeks. The fish oil sup
Sponsors
University Hospital of Montreal (CHUM) Research Centre (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 30-item Inventory of Depressive Symptomatology, self-report (IDS-SR), administered at baseline, 1, 2, 4 and 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Montgomery-Asberg Depression Rating Scale (MADRS) will be completed at baseline, 1, 2, 4 and 8 weeks to allow comparison with standard pharmaceutical trials 2. Rate, type and severity of non-serious adverse events 3. Rate and type of serious adverse events | — |
Countries
Canada
Outcome results
None listed