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A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00289484
Recruitment Status : Unknown
Verified September 2006 by The University of New South Wales.
Recruitment status was:  Recruiting
First Posted : February 9, 2006
Last Update Posted : September 13, 2006
Sponsor:
Collaborators:
Your Health Inc.
Sphere Healthcare
Ocean Nutrition
Information provided by:
The University of New South Wales

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 9, 2006
Last Update Posted Date September 13, 2006
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
Change form pretreatment score on Depression Rating scale at 4 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
  • Daily mood rating
  • Weekly measure of depression
  • Weekly measure of anxiety
  • Weekly measure of functional status
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression
Official Title  ICMJE A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acid as an Augmentor of Antidepressant Medication for Major Depression.
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
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE Drug: Omega-3 Polyunsaturated Fatty Acids
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: February 7, 2006)
52
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00289484
Other Study ID Numbers  ICMJE 05156
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE
  • Your Health Inc.
  • Sphere Healthcare
  • Ocean Nutrition
Investigators  ICMJE
Principal Investigator: Gordon B Parker, Dsc MD PhD Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute
PRS Account The University of New South Wales
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP