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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/NCT00238758




Registration number
NCT00238758
Ethics application status
Date submitted
11/10/2005
Date registered
13/10/2005
Date last updated
13/09/2006

Titles & IDs
Public title
A Study of Omega-3 as a Treatment for Major Depression
Scientific title
A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression
Secondary ID [1] 0 0
05157
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 0 0
Dysthymia 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 from pretreatment score on Depression Rating Scale at 6 weeks.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Weekly measure of depressive symptoms
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Weekly measure of anxiety symptoms
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Weekly measure of functional status
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Must meet DSM IV criteria for non-psychotic major depression lasting at least 6 weeks
or dysthymia.

- Must be under the care of a mental health practitioner.

- Must be able to give informed consent.

- Must be able to attend the Black Dog Institute.
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically
adequate doses and duration.

- 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.

- Taking antidepressant medication for depression.

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

- Pregnancy, breast feeding or planning 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.

- Patients who, in the investigator's judgment pose a current serious suicidal or other
safety risk, or patients who are not likely to 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
1/10/2005
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 omega-3 polyunsaturated fatty acids are
effective as a monotherapy for depression.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00238758
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
Anne Marie Rees, BSc MBBS
Address 0 0
Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & 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
+ 61 2 9382 4521
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/NCT00238758