Condition category
Mental and Behavioural Disorders
Date applied
09/09/2005
Date assigned
31/10/2005
Last edited
02/11/2011
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 Francois Lesperance

ORCID ID

Contact details

Department of Psychiatry
CHUM
1560 Sherbrooke E
M-3234
Montreal
H2L 4M1
Canada
+1 514 890 8000 ext 25678
francois.lesperance@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Double-blind, placebo-controlled, randomised trial of eicosapentaenoic acid (EPA) for major depression

Acronym

Omega-3-D

Study hypothesis

1. To determine whether 1050 mg per day of eicosapentaenoic acid (EPA) is more effective than placebo (sunflower oil) in reducing depressive symptoms over 8 weeks
2. To report data on the tolerability and the safety of EPA in comparison to placebo

Please note that as of 14/01/2009 this record was updated to include the actual start and end dates of the trial. The initial anticipated trial dates were as follows:
Initial anticipated start date: 21/09/2005
Initial anticipated end date: 21/09/2007

Please also note that the target sample size at the end of recruitment was 432 participants; the initial target number of participants was 508. This target sample size change was approved by the Data and Safety Monitoring Committee in June 2008.

Ethics approval

Centre Hospitalier de l’Université de Montréal Research Ethics Board gave approval on the 30th March 2005 (ref: SL-05.036)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information material can be found on http://www.omega3d.com/3_etude/en_etude_01.html

Condition

Major depression

Intervention

Participants are randomly assigned to take three capsules per day of 500 mg of omega-3 fish oil supplement or a matched sunflower oil placebo (low in omega-3 and omega-6) for 8 weeks. The fish oil supplement consist of the OM3 formula marketed by Isodis Natura containing 70% EPA-5% DHA fish oil ethyl-ester, which provides the equivalent of 1050 mg of eicosapentaenoic acid (EPA) and 150 mg of docosahexaenoic acid (DHA) per day.

Intervention type

Drug

Phase

Not Applicable

Drug names

Eicosapentaenoic acid (EPA)

Primary outcome measures

The 30-item Inventory of Depressive Symptomatology, self-report (IDS-SR), administered at baseline, 1, 2, 4 and 8 weeks.

Secondary outcome measures

1. The Montgomery-Asberg Depression Rating Scale (MADRS) will be completed at baseline, 1, 2, 4 and 8 weeks to allow comparison with standard pharmaceutical trials
2. Rate, type and severity of non-serious adverse events
3. Rate and type of serious adverse events

Overall trial start date

17/10/2005

Overall trial end date

05/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Greater than 18 years of age, either sex
2. Current diagnosis of major depressive episode based on the Mini-International Neuropsychiatric Interview (MINI version 5.0.0)
3. Inventory of Depressive Symptomatology (IDS-SR) score greater or equal to 27
4. Presence of significant depressive symptoms for at least 4 weeks, as judged by the clinician
5. If on antidepressants, has been at maximum recommended tolerable dosage for greater than 4 weeks
6. If not on antidepressants, has been either intolerant to at least two previous trials of antidepressants or refuses to take an antidepressant despite medical advice
7. Provision of signed informed consent for participation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

432

Participant exclusion criteria

1. Known allergy to fish or sunflower oil
2. Known intolerance of fish oil supplements
3. Has taken greater than 28 capsules of fish oil supplements during the last 4 weeks
4. Current alcohol or drug abuse or dependency based on the MINI
5. Bipolar disorder based on the MINI
6. Significant suicidal risk based on clinical judgement
7. Pregnant women (all non-menopausal women will need to have a negative pregnancy test before randomisation) and those planning to become pregnant over the course of the trial, or women of child bearing potential not using an accepted method of contraception
8. With coagulation diseases and/or subjects regularly taking any drugs or herbs that thin the blood such as aspirin, heparin, clopidogrel, warfarin, dalteparin, dipyrdamole, enoxaparin, ticlopedine, and gingko
9. History of myocardial infarction
10. Pancreatic insufficiency
11. Investigator's judgement that the patient is unable/unwilling to comply with study regimen

Recruitment start date

17/10/2005

Recruitment end date

05/12/2008

Locations

Countries of recruitment

Canada

Trial participating centre

Department of Psychiatry
Montreal
H2L 4M1
Canada

Sponsor information

Organisation

University Hospital of Montreal (CHUM) Research Centre (Canada)

Sponsor details

3850 St-Urbain
Montreal
H2W 1T7
Canada
+1 514 890 8110
jacques.turgeon.chum@ssss.gouv.qc.ca

Sponsor type

Hospital/treatment centre

Website

http://www.chumontreal.qc.ca

Funders

Funder type

Industry

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20584525

Publication citations

  1. Results

    Lespérance F, Frasure-Smith N, St-André E, Turecki G, Lespérance P, Wisniewski SR, The efficacy of omega-3 supplementation for major depression: a randomized controlled trial., J Clin Psychiatry, 2011, 72, 8, 1054-1062, doi: 10.4088/JCP.10m05966blu.

Additional files

Editorial Notes