Major DepressionPhase 2NCT00238758
A Study of Omega-3 as a Treatment for Major Depression
A Phase 2 study testing Omega-3 Polyunsaturated Fatty Acids in people with Major Depression and Dysthymia, run by The University of New South Wales at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Major Depression, Dysthymia
- What is being tested?
- Omega-3 Polyunsaturated Fatty Acids
- How many people
- 128 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The University of New South Wales/ Black Dog Institute
Sydney, New South Wales, 2031
Catherine Owen, Bsc (hons), 02 9382 4521, omega3study@unsw.edu.au
About this study
Official title: A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression
The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.
Read the detailed description
The study will be a 6 week, parallel-group, double-blind randomized controlled trial of the efficacy of Omega-3 as a monotherapy for depression. People aged 21-65 who have major depression but are not currently on an antidepressant or planning to take an antidepressant in the next 14 weeks will be recruited. Participants will be randomly allocated to receive Omega-3 (fish oil) or placebo (paraffin oil) for 6 weeks. Participants will be followed up weekly and will be asked to rate their mood daily for the 6 week study period. Blood samples will be taken pre and post treatment to measure change in omega-3 levels. At the end of 6 weeks all participants will receive a further 8 weeks supply of omega-3.
- Conditions
- Major Depression, Dysthymia
- Being tested
- Omega-3 Polyunsaturated Fatty Acids
- Keywords
- Mood Disorder
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Polyunsaturated Fatty AcidsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pretreatment score on Depression Rating Scale at 6 weeks.
Secondary outcomes (3)
Weekly measure of depressive symptoms
Weekly measure of anxiety symptoms
Weekly measure of functional status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 128 participants
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Your Health Inc., Sphere Healthcare, Ocean Nutrition
- Investigators
- Anne Marie Rees, BSc MBBS, Principal investigator, Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog InstituteGordon B Parker, Dsc MD PhD, Study director, Professor, School of Psychiatry UNSW and Executive Director, Black Dog Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238758
- Sponsor's protocol ID
- 05157
- Status last verified
- Sep 2006
- First submitted
- 11 Oct 2005
- Last updated
- 13 Sep 2006
- Results posted
- No
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.
PubMed 15777365Parker 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.
PubMed 16741195
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression
- ClinicalTrials.gov ID
- NCT00238758
- Acronym / sponsor ID
- 05157
- Conditions
- Major Depression, Dysthymia
- Keywords
- Mood Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Your Health Inc., Sphere Healthcare, Ocean Nutrition
- Study start
- Oct 2005
- First posted
- 13 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.
Detailed description
The study will be a 6 week, parallel-group, double-blind randomized controlled trial of the efficacy of Omega-3 as a monotherapy for depression. People aged 21-65 who have major depression but are not currently on an antidepressant or planning to take an antidepressant in the next 14 weeks will be recruited. Participants will be randomly allocated to receive Omega-3 (fish oil) or placebo (paraffin oil) for 6 weeks. Participants will be followed up weekly and will be asked to rate their mood daily for the 6 week study period. Blood samples will be taken pre and post treatment to measure change in omega-3 levels. At the end of 6 weeks all participants will receive a further 8 weeks supply of omega-3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Polyunsaturated Fatty Acids | Drug | – |
Primary outcome
Change from pretreatment score on Depression Rating Scale at 6 weeks.
3 secondary outcomes
Weekly measure of depressive symptoms
Weekly measure of anxiety symptoms
Weekly measure of functional status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
- Background: PubMed 15777365Rees 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.
- Background: PubMed 16741195Parker 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.
- Black Dog Institute websiteLink provided by the sponsor.
- University of NSW, school of psychiatry websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Marie Rees, BSc MBBS principal investigator
Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute
Gordon B Parker, Dsc MD PhD study director
Professor, School of Psychiatry UNSW and Executive Director, Black Dog Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 Polyunsaturated Fatty Acids in people with Major Depression and Dysthymia, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Owen, Bsc (hons) (+ 61 2 9382 4521, omega3study@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from pretreatment score on Depression Rating Scale at 6 weeks.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00238758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2006.