NCT00289484

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

February 7, 2006

Last Update Submit

September 11, 2006

Conditions

Major Depression

Keywords

Mood disorder

Outcome Measures

Primary Outcomes (1)

  • Change form pretreatment score on Depression Rating scale at 4 weeks

Secondary Outcomes (4)

  • Daily mood rating

  • Weekly measure of depression

  • Weekly measure of anxiety

  • Weekly measure of functional status

Interventions

Omega-3 Polyunsaturated Fatty AcidsDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of New South Wales/Black Dog Institute

Sydney, New South Wales, 2031, Australia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15777365BACKGROUND

  • Parker 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.

    PMID: 16741195BACKGROUND

  • Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.

    PMID: 34817851DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorMood Disorders

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Depressive DisorderMental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Gordon B Parker, Dsc MD PhD

    Professor, School of Psychiatry UNSW and Exectutive Director, Black Dog Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Owen, Bsc (hons)

CONTACT

(02) 9382 3717cath.owen@unsw.edu.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 9, 2006

Study Start

February 1, 2006

Last Updated

September 13, 2006

Record last verified: 2006-09

Locations

AU(1)