A Study of Omega-3 as an Augmentor of Antidepressant 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:
NCT00289484
First received: February 7, 2006
Last updated: September 11, 2006
Last verified: September 2006
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression |
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 Acid as an Augmentor of Antidepressant Medication for Major Depression. |
Resource links provided by NLM:
Further study details as provided by The University of New South Wales:
Primary Outcome Measures:
- Change form pretreatment score on Depression Rating scale at 4 weeks
Secondary Outcome Measures:
- Daily mood rating
- Weekly measure of depression
- Weekly measure of anxiety
- Weekly measure of functional status
| Estimated Enrollment: | 52 |
| Study Start Date: | February 2006 |
The study will be a 4 week, parallel-group double blind randomised control trial of the efficacy pf Omega-3 as an augmentor of antidepressant treatment for depression. People aged between 18 and 65 with a first or new episode of depression warranting treatment with antidepressant medication will be recruited. In addition to their antidepressant medication, participants will be randomly allocated to receive either Omega-3 (fish oil) or placebo (paraffin oil)for 4 weeks. Participants will commence treatment with the antidepressant and Omega-3/placebo simultaneously. Participants will be followed up at 1,3 and 4 weeks and will be asked to rate their mood daily for the 4 week study period. Blood samples will be taken pre and post treatment to measure change in Omega-3 levels.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289484
Contacts
| Contact: Catherine Owen, Bsc (hons) | (02) 9382 3717 | cath.owen@unsw.edu.au |
Locations
| Australia, New South Wales | |
| The University of New South Wales/Black Dog Institute | Recruiting |
| Sydney, New South Wales, Australia, 2031 | |
| Sub-Investigator: Anne-Marie Rees, BSc MBBS | |
| Principal Investigator: Gordon B Parker, Dsc MD PhD | |
| Sub-Investigator: Catherine Owen, Bsc (hons) | |
| Sub-Investigator: Lucy Tully, BA (hons) | |
| Sub-Investigator: Heather Brotchie, MBBS | |
Sponsors and Collaborators
The University of New South Wales
Your Health
Sphere Healthcare
Ocean Nutrition
Investigators
| Principal Investigator: | Gordon B Parker, Dsc MD PhD | Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00289484 History of Changes |
| Other Study ID Numbers: | 05156 |
| Study First Received: | February 7, 2006 |
| 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 Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013