Condition category
Mental and Behavioural Disorders
Date applied
20/12/2006
Date assigned
13/02/2007
Last edited
06/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sylvie Dodin

ORCID ID

Contact details

Foundation Lucie et André Chagnon
Laval University
Saint-François d'Assise Hospital (CHUQ)
45 Leclerc Street
Office D6-721
Québec
G1L 2G1
Canada
+1 418 525 4348
sylvie.dodin@ogy.ulaval.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 names

Eicosapentaenoic acid (EPA), docosahexaeonic acid (DHA)

Primary outcome measures

Psychological distress based on General Well-Being Scale (GWB) administered at baseline, four and eight weeks.

Secondary outcome measures

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

Overall trial start date

01/03/2005

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

144

Participant 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

Recruitment start date

01/03/2005

Recruitment end date

01/02/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Foundation Lucie et André Chagnon
Québec
G1L 2G1
Canada

Sponsor information

Organisation

Foundation Lucie et André Chagnon (Canada)

Sponsor details

Laval University
Saint-François d'Assise Hospital (CHUQ)
45 Leclerc Street
Office D6-721
Québec
G1L 2G1
Canada
+1 418 525 4348
sylvie.dodin@ogy.ulaval.ca

Sponsor type

Charity

Website

http://www.fondationchagnon.org

Funders

Funder type

Charity

Funder name

Foundation Lucie et André Chagnon, Laval University (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Isodis Natura (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19116322

Publication citations

  1. Results

    Lucas M, Asselin G, Mérette C, Poulin MJ, Dodin S, Ethyl-eicosapentaenoic acid for the treatment of psychological distress and depressive symptoms in middle-aged women: a double-blind, placebo-controlled, randomized clinical trial., Am. J. Clin. Nutr., 2009, 89, 2, 641-651, doi: 10.3945/ajcn.2008.26749.

Additional files

Editorial Notes