A Study of Omega-3 as a Treatment for Major Depression
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by The University of New South Wales.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The University of New South Wales
Collaborators:
Your Health
Sphere Healthcare
Ocean Nutrition
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00238758
First received: October 11, 2005
Last updated: September 11, 2006
Last verified: September 2006
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Purpose
The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression Dysthymia |
Drug: Omega-3 Polyunsaturated Fatty Acids |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drug Information available for:
Omega-3 Fatty Acids
U.S. FDA Resources
Further study details as provided by The University of New South Wales:
Primary Outcome Measures:
- Change from pretreatment score on Depression Rating Scale at 6 weeks.
Secondary Outcome Measures:
- Weekly measure of depressive symptoms
- Weekly measure of anxiety symptoms
- Weekly measure of functional status
| Estimated Enrollment: | 128 |
| Study Start Date: | October 2005 |
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.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238758
Contacts
| Contact: Catherine Owen, Bsc (hons) | + 61 2 9382 4521 | omega3study@unsw.edu.au |
Locations
| Australia, New South Wales | |
| The University of New South Wales/ Black Dog Institute | Recruiting |
| Sydney, New South Wales, Australia, 2031 | |
| Contact: Catherine Owen, Bsc (hons) 02 9382 4521 omega3study@unsw.edu.au | |
Sponsors and Collaborators
The University of New South Wales
Your Health
Sphere Healthcare
Ocean Nutrition
Investigators
| Principal Investigator: | Anne Marie Rees, BSc MBBS | Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute |
| Study Director: | Gordon B Parker, Dsc MD PhD | Professor, School of Psychiatry UNSW and Executive Director, Black Dog Institute |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00238758 History of Changes |
| Other Study ID Numbers: | 05157 |
| Study First Received: | October 11, 2005 |
| Last Updated: | September 11, 2006 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by The University of New South Wales:
|
Mood Disorder |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Dysthymic Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013