Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 11:29 PM
Study NCT ID:
NCT00116857
Status:
COMPLETED
Last Update Posted:
2012-09-12
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carneyr@bmc.wustl.edu', 'phone': '314-286-1313', 'title': 'Robert M. Carney, Ph.D.', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sertraline Plus Omega-3 Supplement', 'description': 'Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sertraline/Corn Oil', 'description': 'Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Beck Depression Inventory-II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline Plus Omega-3 Supplement', 'description': 'Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.'}, {'id': 'OG001', 'title': 'Sertraline/Corn Oil', 'description': 'Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and 10 weeks', 'description': 'Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sertraline Plus Omega-3 Supplement', 'description': 'Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday.'}, {'id': 'FG001', 'title': 'Sertraline/Corn Oil', 'description': 'Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sertraline Plus Omega-3 Supplement', 'description': 'Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.'}, {'id': 'BG001', 'title': 'Sertraline/Corn Oil', 'description': 'Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-11', 'studyFirstSubmitDate': '2005-06-30', 'resultsFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2005-06-30', 'lastUpdatePostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-11', 'studyFirstPostDateStruct': {'date': '2005-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory-II', 'timeFrame': 'Measured at Baseline and 10 weeks', 'description': 'Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Depression', 'Heart Diseases', 'Myocardial Infarction', 'Angina, Unstable']}, 'referencesModule': {'references': [{'pmid': '19843899', 'type': 'RESULT', 'citation': 'Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Harris WS. Omega-3 augmentation of sertraline in treatment of depression in patients with coronary heart disease: a randomized controlled trial. JAMA. 2009 Oct 21;302(15):1651-7. doi: 10.1001/jama.2009.1487.'}, {'pmid': '34817851', 'type': 'DERIVED', 'citation': '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': '26930527', 'type': 'DERIVED', 'citation': 'Carney RM, Steinmeyer BC, Freedland KE, Rubin EH, Rich MW, Harris WS. Baseline blood levels of omega-3 and depression remission: a secondary analysis of data from a placebo-controlled trial of omega-3 supplements. J Clin Psychiatry. 2016 Feb;77(2):e138-43. doi: 10.4088/JCP.14m09660.'}, {'pmid': '21665007', 'type': 'DERIVED', 'citation': 'Bot M, Carney RM, Freedland KE, Rubin EH, Rich MW, Steinmeyer BC, Mann DL. Inflammation and treatment response to sertraline in patients with coronary heart disease and comorbid major depression. J Psychosom Res. 2011 Jul;71(1):13-7. doi: 10.1016/j.jpsychores.2010.11.006. Epub 2011 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).', 'detailedDescription': 'BACKGROUND:\n\nDepression is a risk factor for morbidity and mortality following an acute MI and unstable angina. Two recent studies (sertraline versus placebo and sertraline plus cognitive therapy versus usual care) reported only modest reductions in depression following an acute MI or unstable angina, and many treated patients remained depressed. Neither study reported better medical outcomes in the treated patients. Earlier studies found that even subclinical depression increases the risk of mortality in cardiac patients. Thus, more effective treatments are needed to eliminate depression and improve medical outcomes in patients following an acute MI or unstable angina. Omega-3 FAs have been shown to augment the efficacy of antidepressants for major depression and to improve several cardiac risk factors. However, these findings have been shown in separate lines of research. No previous study has investigated whether omega-3 FAs can simultaneously improve depression and reduce cardiovascular risk factors in post-MI patients.\n\nDESIGN NARRATIVE:\n\nOne hundred fifty patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a current major depressive episode and who score 15 or higher on the Beck Depression Inventory II with a history of acute MI, unstable angina, or other cardiac event will be enrolled in a randomized, double-blind, placebo-controlled trial of omega-3 augmentation of sertraline. The participants will be randomly assigned to receive either sertraline plus omega-3 or sertraline plus placebo for 10 weeks. At baseline and again after ten weeks, the subjects will complete the following: 1) assessments of depression and psychosocial functioning; 2) 24-hour electrocardiogram monitoring for heart rate variability analysis; and 3) blood draws to measure procoagulant and proinflammatory markers, and plasma levels of sertraline and omega-3. If this study shows that omega-3 reduces depression and improves cardiovascular disease markers, there will be a basis for proposing a larger clinical trial to determine whether it can also improve survival after hospitalization for acute MI or unstable angina.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets the DSM-IV criteria for a current major depressive episode\n* Score of 15 or higher on the Beck Depression Inventory II\n* History of acute myocardial infarction, unstable angina, or documented coronary disease\n\nExclusion Criteria:\n\n* Physician or patient refusal\n* Lives far away from study site\n* Current alcohol or drug abuse\n* Psychosis, dementia, or bipolar disorder\n* Already taking Omega-3\n* Medically ill or disabled such that patient is unable to participate\n* Comorbid illness likely to be fatal within 1 year of study entry\n* Seizure disorder or takes anticonvulsants\n* Pregnant or breast feeding\n* Liver or kidney disease\n* Severe hypertriglyceridemia (greater than 400 mg/dL)\n* Bleeding or clotting disorder\n* Type 2 diabetes with a hemoglobin A1c (HbA1c) level greater than 10\n* Taking lithium or monoamine oxidase inhibitor (MAO-I)'}, 'identificationModule': {'nctId': 'NCT00116857', 'briefTitle': 'Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Omega-3 for Depression and Other Cardiac Risk Factors', 'orgStudyIdInfo': {'id': '186'}, 'secondaryIdInfos': [{'id': 'R01HL076808', 'link': 'https://reporter.nih.gov/quickSearch/R01HL076808', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sertraline/omega-3 supplement', 'interventionNames': ['Drug: Sertraline/omega-3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sertraline/corn oil', 'interventionNames': ['Drug: Sertraline/Corn Oil']}], 'interventions': [{'name': 'Sertraline/omega-3', 'type': 'DRUG', 'description': 'Sertraline (50 mgs) plus omega-3 (2 grams)', 'armGroupLabels': ['Sertraline/omega-3 supplement']}, {'name': 'Sertraline/Corn Oil', 'type': 'DRUG', 'description': 'Sertraline (50 mgs) plus corn oil (2 grams) (placebo)', 'armGroupLabels': ['Sertraline/corn oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Robert M. Carney, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Carney', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}