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Double-blind, placebo-controlled, randomised, clinical trial of eicosapentaenoic acid in the treatment of mood disorders among middle-aged women
ISRCTN ISRCTN69617477
DOI 10.1186/ISRCTN69617477
ClinicalTrials.gov identifier
EudraCT number
Public title Double-blind, placebo-controlled, randomised, clinical trial of eicosapentaenoic acid in the treatment of mood disorders among middle-aged women
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis To determine whether fish oil supplement rich in eicosapentaenoic acid (EPA) is more effective than placebo (sunflower oil) in reducing distress and depressive symptoms over eight weeks.
Lay summary
Ethics approval This project received ethics approval on March 25, 2004 from the Ethical Committee of the clinical research of the Saint-François d'Assise Hospital. On the 17th December 2004 we received, for this study, the agreement of the Bureau Product Review and Assessment (BPRA) of the Natural Health Products Directorate (NHPD) of Health (Canada).
Study design Double-blind, placebo-controlled, randomised, clinical trial
Countries of recruitment Canada
Disease/condition/study domain Mild to moderate major depression, moderate to severe psychological distress
Participants - 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
Participants - 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-Johnís 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
Anticipated start date 01/03/2005
Anticipated end date 01/02/2007
Status of trial Completed
Patient information material
Target number of participants 144
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 Natura. Each 500 mg capsule of OM3® contains 350 mg of EPA and 50 mg of Docosahexaeonic Acid (DHA). Women will have to take one capsule three times a day (before each meal). The three omega-3 capsules will correspond to a daily intake of 1.05 g of EPA and 150 mg of DHA for a total of 1.2 g of omega-3 fatty acids per day.
Primary outcome measure(s) Psychological distress based on General Well-Being Scale (GWB) administered at baseline, four and eight weeks.
Secondary outcome measure(s) 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
Sources of funding 1. Foundation Lucie et André Chagnon, Laval University (Canada)
2. Isodis Natura (Canada)
Trial website
Publications 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19116322
Contact name Dr  Sylvie  Dodin
  Address Foundation Lucie et André Chagnon
Laval University
Saint-François d'Assise Hospital (CHUQ)
45 Leclerc Street
Office D6-721
  City/town Québec
  Zip/Postcode G1L 2G1
  Country Canada
  Tel +1 418 525 4348
  Fax +1 418 525 4427
  Email sylvie.dodin@ogy.ulaval.ca
Sponsor Foundation Lucie et André Chagnon (Canada)
  Address Laval University
Saint-François d'Assise Hospital (CHUQ)
45 Leclerc Street
Office D6-721
  City/town Québec
  Zip/Postcode G1L 2G1
  Country Canada
  Tel +1 418 525 4348
  Fax +1 418 525 4427
  Email sylvie.dodin@ogy.ulaval.ca
  Sponsor website: http://www.fondationchagnon.org
Date applied 20/12/2006
Last edited 06/01/2009
Date ISRCTN assigned 13/02/2007
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