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 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Sylvie Dodin
Scientific
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 |
|---|---|
| sylvie.dodin@ogy.ulaval.ca |
Study information
| Study design | Double-blind, placebo-controlled, randomised, clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| 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(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). |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Eicosapentaenoic acid (EPA), docosahexaeonic acid (DHA) |
| Primary outcome measure | 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 study start date | 01/03/2005 |
| Overall study end date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 144 |
| 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 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 |
| Recruitment start date | 01/03/2005 |
| Recruitment end date | 01/02/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Foundation Lucie et André Chagnon
Québec
G1L 2G1
Canada
G1L 2G1
Canada
Sponsor information
Foundation Lucie et André Chagnon (Canada)
Charity
Charity
Laval University
Saint-François d'Assise Hospital (CHUQ)
45 Leclerc Street
Office D6-721
Québec
G1L 2G1
Canada
| Phone | +1 418 525 4348 |
|---|---|
| sylvie.dodin@ogy.ulaval.ca | |
| Website | http://www.fondationchagnon.org |
"ROR" |
https://ror.org/05ret9323 |
Funders
Funder type
Charity
Foundation Lucie et André Chagnon, Laval University (Canada)
No information available
Isodis Natura (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
