NCT00238758

Brief Summary

The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ 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

October 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

October 11, 2005

Last Update Submit

September 11, 2006

Conditions

Major DepressionDysthymia

Keywords

Mood Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from pretreatment score on Depression Rating Scale at 6 weeks.

Secondary Outcomes (3)

  • Weekly measure of depressive symptoms

  • Weekly measure of anxiety symptoms

  • Weekly measure of functional status

Interventions

Omega-3 Polyunsaturated Fatty AcidsDRUG

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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 (2)

  • 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

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDysthymic DisorderMood 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

  • Anne Marie Rees, BSc MBBS

    Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute

    PRINCIPAL INVESTIGATOR

  • Gordon B Parker, Dsc MD PhD

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

    STUDY DIRECTOR

Central Study Contacts

Catherine Owen, Bsc (hons)

CONTACT

+ 61 2 9382 4521omega3study@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

October 11, 2005

First Posted

October 13, 2005

Study Start

October 1, 2005

Last Updated

September 13, 2006

Record last verified: 2006-09

Locations

AU(1)