Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000598381
Ethics application status
Approved
Date submitted
29/09/2008
Date registered
1/12/2008
Date last updated
1/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fish oil treatment for depression in cardiovascular disease
Scientific title
Omega-3 fatty acid supplementation for symptoms of depression in patients with cardiovascular disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 3353 0
Cardiovascular Disease 3354 0
Condition category
Condition code
Mental Health 3509 3509 0 0
Depression
Cardiovascular 3510 3510 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will be required to consume four 1 gram capsules of eicosapentaenoic acid (EPA)-rich fish oil per day for 6 months.
Each capsule will contain 500mg of eicosapentaenoic acid (EPA) and 25 mg of docosahexaenoic acid (DHA)
These capsules will be taken orally.
Intervention code [1] 3088 0
Lifestyle
Comparator / control treatment
Volunteers will be required to consume four 1 gram capsules of soybean/corn oil per day for 6 months.
Each capsule will contain 500mg of soybean oil and 500 mg of corn oil
These capsules will be taken orally.
Control group
Placebo

Outcomes
Primary outcome [1] 4412 0
Depression as measured by the Hamilton Rating Scale For Depression
Timepoint [1] 4412 0
Baseline, 3 months, 6 months
Secondary outcome [1] 7443 0
Quality of Life as measured by the Short Form (SF)-36
Timepoint [1] 7443 0
Baseline, 3 months, 6 months
Secondary outcome [2] 7444 0
Angina frequency as measured by the Seattle Angina Questionnaire
Timepoint [2] 7444 0
Baseline, 3 months, 6 months
Secondary outcome [3] 7445 0
Degree of change in vasodilator function assessed by flow mediated dilatation (FMD) in the brachial artery
Timepoint [3] 7445 0
Baseline, 6 months
Secondary outcome [4] 7446 0
Changes in cerebral blood flow measured by transcranial Doppler ultrasound
Timepoint [4] 7446 0
Baseline, 6 months

Eligibility
Key inclusion criteria
(a) angiographically-documented coronary artery disease, defined as >50% stenosis in an epicardial coronary artery on selective coronary angiography.
(b) Co-morbid depression as determined by a score of greater than or equal to 16 on the Center for Epidemiologic Studies – Depression (CES-D) scale
(c) able to complete questionnaires in written English.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) more than one fish meals per week
(b) currently using fish oil supplementation (>300mg eicosapentaenoic acid (EPA)+ docosahexaenoic acid (DHA)/day)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Depressed participants will be selected from the angiographic database at the Queen Elizabeth Hospital. Patients will be randomly assigned according to a random numbers system administered by an individual who is independent of the study. All contact between the research nurse (who will determine eligibility) and the person who holds the randomisation schedule will be via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3925 0
Charities/Societies/Foundations
Name [1] 3925 0
This project is funded by a joint strategic initiative of the Australian National Heart Foundation and Beyond Blue
Country [1] 3925 0
Australia
Primary sponsor type
Individual
Name
Dr Geoffrey Schrader
Address
Department of Psychiatry
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South 5011
Country
Australia
Secondary sponsor category [1] 3529 0
Individual
Name [1] 3529 0
Professor Peter Howe
Address [1] 3529 0
Nutritional Physiology Research Centre, University of South Australia
PO Box 2471
Adelaide, 5001
Country [1] 3529 0
Australia
Secondary sponsor category [2] 3530 0
Individual
Name [2] 3530 0
Dr John Beltrame
Address [2] 3530 0
Department of Medicine
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South 5011
Country [2] 3530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5990 0
Central northern adelaide health service ethics of human research committee
Ethics committee address [1] 5990 0
28 Woodville Road,
Woodville South, SA 5011
Ethics committee country [1] 5990 0
Australia
Date submitted for ethics approval [1] 5990 0
Approval date [1] 5990 0
12/08/2008
Ethics approval number [1] 5990 0
2008104
Ethics committee name [2] 5991 0
University of South Australia Human Research Ethics Committe
Ethics committee address [2] 5991 0
General Purpose Building
Mawson Lakes campus
Mawson Lakes Boulevard
Mawson Lakes
South Australia 5095
Ethics committee country [2] 5991 0
Australia
Date submitted for ethics approval [2] 5991 0
Approval date [2] 5991 0
24/09/2008
Ethics approval number [2] 5991 0
P223/08

Summary
Brief summary
The aim of this project is to evaluate the potential for supplementation with long-chain omega-3 fatty acids to relieve depressive symptoms and improve health status in cardiac patients suffering from depression. The study will explore potential mechanisms mediating these benefits, with a particular focus on the role of serotonin transporter gene polymorphisms and changes in cerebral blood flow. It is anticipated that depressive symptoms will be greatest in people who have reduced cerebral blood flow and a particular form of serotonin transporter gene. However, it is expected that omega-3 supplementation will increase serotonin receptor expression and cerebral blood flow, thereby improving depressive symptoms, but that these improvements will be less in people who carry the 5HTT-S gene. It is also expected that omega-3 supplementation will improve peripheral blood vessel function, which will be associated with improvements in depressive symptoms and angina scores.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28719 0
Address 28719 0
Country 28719 0
Phone 28719 0
Fax 28719 0
Email 28719 0
Contact person for public queries
Name 11876 0
Dr Geoffrey Schrader
Address 11876 0
Department of Psychiatry
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South 5011
Country 11876 0
Australia
Phone 11876 0
+61 8 82226909
Fax 11876 0
+61 8 82226025
Email 11876 0
geoffrey.schrader@adelaide.edu.au
Contact person for scientific queries
Name 2804 0
Professor Peter Howe
Address 2804 0
Nutritional Physiology Research Centre, University of South Australia
PO Box 2471
Adelaide, 5000
Country 2804 0
Australia
Phone 2804 0
+61 8 83021200
Fax 2804 0
+61 8 83022178
Email 2804 0
peter.howe@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThere is No Association Between the Omega-3 Index and Depressive Symptoms in Patients With Heart Disease Who Are Low Fish Consumers.2017https://dx.doi.org/10.1016/j.hlc.2016.07.003
N.B. These documents automatically identified may not have been verified by the study sponsor.