Mild to moderate major depression, moderate to severe psychological distress Mental and Behavioural Disorders Depression
Conditions
Interventions
Women will be randomly assigned to a dietary supplement (OM3®) rich in omega-3 fatty acids (1.2 g/day) or a placebo (sunflower oil) for a period of eight weeks. Each capsule will be provided by Isodis
Sponsors
Foundation Lucie et André Chagnon (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women between 40 and 55 years of age 2. Moderate to severe psychological distress based on General Well-Being Scale (GWB) (score less than 72) 3. Have a negative results on a pregnancy test and currently using an adequate method of contraception 4. Provision of signed informed consent for participation
Exclusion criteria
Exclusion criteria: 1. Hamilton-21 score of 26 or more, or Patient Health Questionnaire (PHQ-9) score of 20 or more 2. Past or current history of schizophrenia or bipolar I disorders 3. Current or significant imminent risk of suicide or homicide 4. Post-menopausal for more than five years 5. Major medical disorders such as malabsorption disease, gastrectomy and acute pancreatitis 6. Inherited or acquired disease of the haemostatic or the coagulation 7. Medical conditions that interfere with the digestion and the absorption of medication 8. Taking antihypertensive medications or suffer from hypercholesterolaemia or diabetes type two 9. Endocrine diseases that could be linked to psychiatry 10. Others medical causes that could be linked to psychiatry 11. Have a current substance abuse disorders such as drugs (marijuana, cocaine, etc.) or alcohol (more than 40 g of alcohol by day) 12. Fish allergies 13. Have regularly consumed fish (more than three serving per week) in the last months 14. Have taken antidepressant medication or hormone replacement therapy (HRT) or St-John?s Wort (Hypericum Perforatum) in the last six months before enrolment 15. Current use of any drugs that thin blood such as aspirin, ibuprofen, heparin, clopidogel, warfarin, dalteparin, dipyrimadole, enoxaparin, ticlopidine, ginkgo or other anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychological distress based on General Well-Being Scale (GWB) administered at baseline, four and eight weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hamilton-21 Depression (HAM-D) Rating Scale administered at baseline and eight weeks 2. Depression subscale of the Symptom Check-List-90-R (SCL-Dep) administered at baseline, four and eight weeks 3. Frequency and severity of menopause vasomotor symptoms administered at baseline, four and eight weeks 4. Quality of life (MENopause Specific Quality Of Life [MENQOL], Short Form health survey [SF36], fatigue, sexual activities, work limitations, sleep problems) administered at baseline and eight weeks 5. Clinical Global Impression of improvement evaluated by doctor (CGI) and by the patient (Patient Global Impression of Improvement [PGI-I]) administered at baseline and eight weeks | — |
Countries
Canada
Outcome results
None listed