Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT00238758
Status:
UNKNOWN
Last Update Posted:
2006-09-13
First Post:
2005-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Omega-3 as a Treatment for Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019263', 'term': 'Dysthymic Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-09-11', 'studyFirstSubmitDate': '2005-10-11', 'studyFirstSubmitQcDate': '2005-10-11', 'lastUpdatePostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from pretreatment score on Depression Rating Scale at 6 weeks.'}], 'secondaryOutcomes': [{'measure': 'Weekly measure of depressive symptoms'}, {'measure': 'Weekly measure of anxiety symptoms'}, {'measure': 'Weekly measure of functional status'}]}, 'conditionsModule': {'keywords': ['Mood Disorder'], 'conditions': ['Major Depression', 'Dysthymia']}, 'referencesModule': {'references': [{'pmid': '15777365', 'type': 'BACKGROUND', 'citation': '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': '16741195', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.blackdoginstitute.org.au', 'label': 'Black Dog Institute website'}, {'url': 'http://psych.med.unsw.edu.au', 'label': 'University of NSW, school of psychiatry website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether omega-3 polyunsaturated fatty acids are effective as a monotherapy for depression.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must meet DSM IV criteria for non-psychotic major depression lasting at least 6 weeks or dysthymia.\n* Must be under the care of a mental health practitioner.\n* Must be able to give informed consent.\n* Must be able to attend the Black Dog Institute.\n\nExclusion Criteria:\n\n* Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically adequate doses and duration.\n* History of psychosis or mania/hypomania or personality disorder.\n* Non-English speaking or otherwise unable to provide historical information.\n* Having taken Omega-3 dietary supplements in the last 3 months.\n* Taking antidepressant medication for depression.\n* History of allergy to n-3 PUFA supplements, finfish or shellfish.\n* Pregnancy, breast feeding or planning to become pregnant during course of study.\n* Post-natal depression.\n* Current drug or alcohol abuse or dependence or history of abuse or dependence over the last 12 months.\n* Unstable thyroid function\n* Hepatic or renal impairment or other medical conditions that may interfere with the absorption and metabolism of omega-3 polyunsaturated fatty acids.\n* Coagulopathy or anticoagulant treatment.\n* 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."}, 'identificationModule': {'nctId': 'NCT00238758', 'briefTitle': 'A Study of Omega-3 as a Treatment for Major Depression', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo Controlled Trial of Omega-3 Polyunsaturated Fatty Acids as a Monotherapy for Major Depression', 'orgStudyIdInfo': {'id': '05157'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Omega-3 Polyunsaturated Fatty Acids', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Catherine Owen, Bsc (hons)', 'role': 'CONTACT', 'email': 'omega3study@unsw.edu.au', 'phone': '02 9382 4521'}], 'facility': 'The University of New South Wales/ Black Dog Institute', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'centralContacts': [{'name': 'Catherine Owen, Bsc (hons)', 'role': 'CONTACT', 'email': 'omega3study@unsw.edu.au', 'phone': '+ 61 2 9382 4521'}], 'overallOfficials': [{'name': 'Anne Marie Rees, BSc MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Research Fellow and Consultant Psychiatrist, School of Psychiatry, UNSW & Black Dog Institute'}, {'name': 'Gordon B Parker, Dsc MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor, School of Psychiatry UNSW and Executive Director, Black Dog Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'collaborators': [{'name': 'Your Health Inc.', 'class': 'OTHER'}, {'name': 'Sphere Healthcare', 'class': 'INDUSTRY'}, {'name': 'Ocean Nutrition', 'class': 'INDUSTRY'}]}}}