Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00289484




Registration number
NCT00289484
Ethics application status
Date submitted
7/02/2006
Date registered
9/02/2006
Date last updated
13/09/2006

Titles & IDs
Public title
A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression
Scientific title
A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acid as an Augmentor of Antidepressant Medication for Major Depression.
Secondary ID [1] 0 0
05156
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Omega-3 Polyunsaturated Fatty Acids

Treatment: Drugs: Omega-3 Polyunsaturated Fatty Acids
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change form pretreatment score on Depression Rating scale at 4 weeks
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Daily mood rating
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Weekly measure of depression
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Weekly measure of anxiety
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Weekly measure of functional status
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Participants must present with a first or new episode of DSM IV non-psychotic major
depression warranting treatment with antidepressant mediation.

- Must be able to give informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of psychosis or mania/hypomania or personality disorder.

- Non-English speaking or otherwise unable to provide historical information.

- Having taken Omega-3 dietary supplements in the last 3 months.

- History of allergy to Omega-3 supplements, finfish or shellfish.

- Pregnancy, breast feeding or plans to become pregnant during course of study.

- Post-natal depression

- Current drug or alcohol abuse or dependence or history of abuse or dependence over the
last 12 months.

- Unstable thyroid function

- Hepatic or renal impairment or other medical conditions that may interfere with the
absorption and metabolism of Omega-3 polyunsaturated fatty acids

- Coagulopathy or anticoagulant treatment due to theoretical bleeding risk.

- Patients who, in the investigator's judgment pose a current serious suicidal or other
safety risk, or patients who will not likely be able to comply with the study
protocol.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The University of New South Wales/Black Dog Institute - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Your Health Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Sphere Healthcare
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Ocean Nutrition
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether augmentation of antidepressant medication
with Omega-3 polyunsaturated fatty acids increases the speed and degree of improvement for
patients with major depression
Trial website
https://clinicaltrials.gov/ct2/show/NCT00289484
Trial related presentations / publications
Rees AM, Austin MP, Parker G. Role of omega-3 fatty acids as a treatment for depression in the perinatal period. Aust N Z J Psychiatry. 2005 Apr;39(4):274-80. doi: 10.1080/j.1440-1614.2005.01565.x.
Parker G, Gibson NA, Brotchie H, Heruc G, Rees AM, Hadzi-Pavlovic D. Omega-3 fatty acids and mood disorders. Am J Psychiatry. 2006 Jun;163(6):969-78. doi: 10.1176/ajp.2006.163.6.969. Erratum In: Am J Psychiatry. 2006 Oct;163(10):1842.
Public notes

Contacts
Principal investigator
Name 0 0
Gordon B Parker, Dsc MD PhD
Address 0 0
Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Catherine Owen, Bsc (hons)
Address 0 0
Country 0 0
Phone 0 0
(02) 9382 3717
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00289484