Double-blind, placebo-controlled, randomised, clinical trial of eicosapentaenoic acid in the treatment of mood disorders among middle-aged wome

Completed

• Conditions: Mild to moderate major depression, moderate to severe psychological distress; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN69617477
• Lead Sponsor: Foundation Lucie et André Chagnon (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 144

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified