Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000710022
Ethics application status
Approved
Date submitted
20/08/2010
Date registered
26/08/2010
Date last updated
15/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
An 8 week randomised, double-blind, placebo controlled trial investigating the role of adjunctive bioactive lipids specifically; docosahexaenoic acid (DHA) versus eicosapentaenoic acid (EPA) in Major Depressive Disorder - with a 6 week open label extension of DHA in patients aged 18-65years.
Scientific title
An 8 week randomised, double-blind, placebo controlled trial investigating the role of adjunctive bioactive lipids specifically; docosahexaenoic acid (DHA) versus eicosapentaenoic acid (EPA) in Major Depressive Disorder - with a 6 week open label extension of DHA in patients aged 18-65years.
Secondary ID [1] 252526 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 258016 0
Condition category
Condition code
Mental Health 258184 258184 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the DHA arm of the study will be given 2 tablets (260 mg/day) of supplementary DHA and patients in the EPA arm will be required to take 2 tablets or 360mg of EPA; patients in the placebo arm will be required to take 2 tablets or 2000mg of sunflower oil. At the completion of the double-blind period (8 weeks) all participants will be switched to DHA (260mg/day) for a 6 week open label extension. In addition and where possible patient’s background antidepressant medication will remain as a fixed dose for the 8 week study period
Intervention code [1] 257057 0
Treatment: Drugs
Comparator / control treatment
Omega-3 fatty acids include both DHA and EPA but it is unclear as to whether there are any differences in their potetial roles in treating depression.
The placebo arm is 2 tablets or 2000mg of sunflower oil taken daily in the a.m. for 8 weeks.
The comparitor is EPA - 360mg taken daily in the a.m. for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 259042 0
Change from baseleine on total scores of the Hamilton Depression Rating Scale (HAM-D)
Timepoint [1] 259042 0
8 weeks from baseline
Secondary outcome [1] 265294 0
change in brain-derived neurotropic factor (BDNF) levels from baseleine
Timepoint [1] 265294 0
8 weeks from baseline

Eligibility
Key inclusion criteria
diagnosis of major depressive episode
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
other serious mental or neurological illness

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)
Outpatients of the clinic who have been on a stable dose of background antidepressant medication for 4 weeks or more and aged 18 to 65 years will be approached to take part in the study. Inclusion criteria will be assessed by a trained clinician who plays no role in the computer generated randomisation. medication will be dispensed by a clinican who plays no role in assessment. All assessments by the trained clinician will be carried out blind to treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257505 0
Commercial sector/Industry
Name [1] 257505 0
Bionutrients Pty Ltd
Country [1] 257505 0
Australia
Primary sponsor type
Hospital
Name
The Melbourne Clinic
Address
130 Church St
Richmond
Vic 3121
Country
Australia
Secondary sponsor category [1] 256741 0
None
Name [1] 256741 0
Address [1] 256741 0
Country [1] 256741 0
Other collaborator category [1] 251450 0
Individual
Name [1] 251450 0
A/Prof Trevor Norman
Address [1] 251450 0
Department of Psychiatry
10th Floor, Sir Lance Townsend Bldg
Austin Hospital
Studley Road
HEIDELBERG 3084
Country [1] 251450 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259532 0
The Melbourne Clinic Research Ethics Committee
Ethics committee address [1] 259532 0
130 Church st
Richmond
Vic 3121
Ethics committee country [1] 259532 0
Australia
Date submitted for ethics approval [1] 259532 0
Approval date [1] 259532 0
11/08/2010
Ethics approval number [1] 259532 0
Project 160

Summary
Brief summary
The primary objective is to evaluate the effectiveness of DHA versus placebo and compare the difference
between DHA and EPA on the symptoms of depression. Effectiveness will be measured by the mean change in
total scores on the HAM-D from baseline to double-blind end point at week 8. Patients with a 50% reduction in
HAM-D scores or who have a score equal to or less than 8 will be considered to be in full remission whilst
patients with a score of 12 or less will be considered to have improved; (from baseline to Week 8 or dropout).
A secondary aim of the study will be to compare the levels of BDNF at baseline and at the completion of the
double-blind phase of the study in the patients treated with DHA versus the comparator EPA and placebo.
An additional aim will be to measure the change from baseline in cognitive functioning using a brief cognitive battery which assess 5 cognitive domains.
Mean change from baseline scores to week 8 will also be used to measure patients Global Assessment of
Functioning, sleep and levels of suicidal ideation using Item 3 on the HAM-D.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31551 0
Address 31551 0
Country 31551 0
Phone 31551 0
Fax 31551 0
Email 31551 0
Contact person for public queries
Name 14798 0
Deidre Smith
Address 14798 0
The Professorial Research Unit
The Melbourne Clinic
130 Church St
Richmond
Vic 3131
Country 14798 0
Australia
Phone 14798 0
61 3 9420 9353
Fax 14798 0
Email 14798 0
[email protected]
Contact person for scientific queries
Name 5726 0
Deidre Smith
Address 5726 0
The Professorial Research Unit
The Melbourne Clinic
130 Church St
Richmond
Vic 3131
Country 5726 0
Australia
Phone 5726 0
61 3 9420 9353
Fax 5726 0
Email 5726 0
[email protected]

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
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