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

ISRCTN	ISRCTN69617477
DOI	https://doi.org/10.1186/ISRCTN69617477
Protocol serial number	N/A
Sponsor	Foundation Lucie et André Chagnon (Canada)
Funders	Foundation Lucie et André Chagnon, Laval University (Canada), Isodis Natura (Canada)

Submission date: 20/12/2006
Registration date: 13/02/2007
Last edited: 06/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sylvie Dodin
Scientific

Foundation Lucie et André Chagnon
Laval University
Saint-François d'Assise Hospital (CHUQ)
45 Leclerc Street
Office D6-721
Québec
G1L 2G1
Canada

Phone	+1 418 525 4348
Email	sylvie.dodin@ogy.ulaval.ca

Study information

Primary study design	Interventional
Study design	Double-blind, placebo-controlled, randomised, clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	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).
Health condition(s) or problem(s) studied	Mild to moderate major depression, moderate to severe psychological distress
Intervention	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Eicosapentaenoic acid (EPA), docosahexaeonic acid (DHA)
Primary outcome measure(s)	Psychological distress based on General Well-Being Scale (GWB) administered at baseline, four and eight weeks.
Key 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
Completion date	01/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	144
Key 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
Key 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-Johns 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
Date of first enrolment	01/03/2005
Date of final enrolment	01/02/2007

Locations

Countries of recruitment

Canada

Study participating centre

Foundation Lucie et André Chagnon

Québec
G1L 2G1
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2009		Yes	No