Treating Depression with Omega-3

ISRCTN	ISRCTN47431149
DOI	https://doi.org/10.1186/ISRCTN47431149
Secondary identifying numbers	N/A

Submission date: 09/09/2005
Registration date: 31/10/2005
Last edited: 02/11/2011

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 Francois Lesperance
Scientific

Department of Psychiatry
CHUM
1560 Sherbrooke E
M-3234
Montreal
H2L 4M1
Canada

Phone	+1 514 890 8000 ext 25678
Email	francois.lesperance@umontreal.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information material can be found on http://www.omega3d.com/3_etude/en_etude_01.html
Scientific title	Double-blind, placebo-controlled, randomised trial of eicosapentaenoic acid (EPA) for major depression
Study acronym	Omega-3-D
Study objectives	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(s)	Centre Hospitalier de lUniversité de Montréal Research Ethics Board gave approval on the 30th March 2005 (ref: SL-05.036)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Eicosapentaenoic acid (EPA)
Primary outcome measure	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 study start date	17/10/2005
Completion date	05/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	432
Key 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
Key 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
Date of first enrolment	17/10/2005
Date of final enrolment	05/12/2008

Locations

Countries of recruitment

Canada

Study participating centre

Department of Psychiatry

Montreal
H2L 4M1
Canada

Sponsor information

University Hospital of Montreal (CHUM) Research Centre (Canada)
Hospital/treatment centre

3850 St-Urbain
Montreal
H2W 1T7
Canada

Phone	+1 514 890 8110
Email	jacques.turgeon.chum@ssss.gouv.qc.ca
Website	http://www.chumontreal.qc.ca
"ROR"	https://ror.org/0410a8y51

Funders

Funder type

Industry

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	01/08/2011		Yes	No