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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
Sponsor:
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

October 11, 2005
September 11, 2006
October 2005
Not Provided
Change from pretreatment score on Depression Rating Scale at 6 weeks.
Same as current
Complete list of historical versions of study NCT00238758 on ClinicalTrials.gov Archive Site
  • Weekly measure of depressive symptoms
  • Weekly measure of anxiety symptoms
  • Weekly measure of functional status
  • Weekly measure of depressive symtoms
  • Weekly measure of anxiety symtoms
  • Weekly measure of functional status
Not Provided
Not Provided
 
A Study of Omega-3 as a Treatment for Major Depression
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Major Depression
  • Dysthymia
Drug: Omega-3 Polyunsaturated Fatty Acids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
Not Provided
Not Provided

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.
Both
21 Years to 65 Years
No
Contact: Catherine Owen, Bsc (hons) + 61 2 9382 4521 omega3study@unsw.edu.au
Australia
 
NCT00238758
05157
Not Provided
Not Provided
The University of New South Wales
  • Your Health
  • Sphere Healthcare
  • Ocean Nutrition
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
The University of New South Wales
September 2006

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