Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00057551
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2003-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Research Evaluating the Value of Augmenting Medication With Psychotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhk2002@med.cornell.edu', 'phone': '212-746-5913', 'title': 'James H. Kocsis, M.D.', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CBASP', 'description': 'Cognitive Behavioral Analysis System of Psychotherapy', 'otherNumAtRisk': 200, 'otherNumAffected': 28, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BriefSP', 'description': 'Supportive Therapy', 'otherNumAtRisk': 195, 'otherNumAffected': 23, 'seriousNumAtRisk': 195, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Medication', 'description': 'Sertraline\n\nEscitalopram\n\nBupropion SR or XL\n\nVenlafaxine XR\n\nMirtazapine', 'otherNumAtRisk': 96, 'otherNumAffected': 8, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'moderate burden', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FISER'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CBASP', 'description': 'Cognitive Behavioral Analysis System of Psychotherapy'}, {'id': 'OG001', 'title': 'Brief SP', 'description': 'Supportive Therapy'}, {'id': 'OG002', 'title': 'Medication Only', 'description': 'Sertraline\n\nEscitalopram\n\nBupropion SR or XL\n\nVenlafaxine XR\n\nMirtazapine'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '31.0', 'groupId': 'OG001'}, {'value': '39.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Hamilton Depression Scale (HAM-D)\\<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Refers to # of subjects who completed 12 weeks of treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBASP', 'description': 'Cognitive Behavioral Analysis System of Psychotherapy'}, {'id': 'FG001', 'title': 'BriefSP', 'description': 'Brief Supportive Psychotherapy'}, {'id': 'FG002', 'title': 'Medication Only', 'description': 'An algorithm including Sertraline, Escitalopram\n\nBupropion SR or XL\n\nVenlafaxine XR\n\nMirtazapine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '195'}, {'groupId': 'FG002', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '168'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '491', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CBASP', 'description': 'Cognitive Behavioral Analysis System of Psychotherapy'}, {'id': 'BG001', 'title': 'Brief Supportive P', 'description': 'Brief Supportive Psychotherapyherapy'}, {'id': 'BG002', 'title': 'Medication Only', 'description': 'Sertraline\n\nEscitalopram\n\nBupropion SR or XL\n\nVenlafaxine XR\n\nMirtazapine'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '46.4', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '11.9', 'groupId': 'BG002'}, {'value': '45.9', 'spread': '11.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '491', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hamilton Depression Scale', 'classes': [{'categories': [{'measurements': [{'value': '19.52', 'spread': '8.26', 'groupId': 'BG000'}, {'value': '19.44', 'spread': '8.31', 'groupId': 'BG001'}, {'value': '18.4', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '19.48', 'spread': '8.27', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 0-72 with higher scores indicating more severe depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 491}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-01', 'studyFirstSubmitDate': '2003-04-04', 'resultsFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2003-04-04', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-03', 'studyFirstPostDateStruct': {'date': '2003-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission', 'timeFrame': '12 weeks', 'description': 'Hamilton Depression Scale (HAM-D)\\<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression', 'Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '10816183', 'type': 'BACKGROUND', 'citation': 'Keller MB, McCullough JP, Klein DN, Arnow B, Dunner DL, Gelenberg AJ, Markowitz JC, Nemeroff CB, Russell JM, Thase ME, Trivedi MH, Zajecka J. A comparison of nefazodone, the cognitive behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression. N Engl J Med. 2000 May 18;342(20):1462-70. doi: 10.1056/NEJM200005183422001.'}, {'pmid': '9831997', 'type': 'BACKGROUND', 'citation': 'Keller MB, Kocsis JH, Thase ME, Gelenberg AJ, Rush AJ, Koran L, Schatzberg A, Russell J, Hirschfeld R, Klein D, McCullough JP, Fawcett JA, Kornstein S, LaVange L, Harrison W. Maintenance phase efficacy of sertraline for chronic depression: a randomized controlled trial. JAMA. 1998 Nov 18;280(19):1665-72. doi: 10.1001/jama.280.19.1665.'}, {'pmid': '12858425', 'type': 'BACKGROUND', 'citation': 'McCullough JP Jr. Treatment for chronic depression using Cognitive Behavioral Analysis System of Psychotherapy (CBASP). J Clin Psychol. 2003 Aug;59(8):833-46. doi: 10.1002/jclp.10176.'}, {'pmid': '28068460', 'type': 'DERIVED', 'citation': 'Shankman SA, Gorka SM, Katz AC, Klein DN, Markowitz JC, Arnow BA, Manber R, Rothbaum BO, Thase ME, Schatzberg AF, Keller MB, Trivedi MH, Kocsis JH. Side Effects to Antidepressant Treatment in Patients With Depression and Comorbid Panic Disorder. J Clin Psychiatry. 2017 Apr;78(4):433-440. doi: 10.4088/JCP.15m10370.'}, {'pmid': '23102821', 'type': 'DERIVED', 'citation': 'Shankman SA, Campbell ML, Klein DN, Leon AC, Arnow BA, Manber R, Keller MB, Markowitz JC, Rothbaum BO, Thase ME, Kocsis JH. Dysfunctional attitudes as a moderator of pharmacotherapy and psychotherapy for chronic depression. J Psychiatr Res. 2013 Jan;47(1):113-21. doi: 10.1016/j.jpsychires.2012.09.018. Epub 2012 Oct 25.'}, {'pmid': '21500885', 'type': 'DERIVED', 'citation': "Klein DN, Leon AC, Li C, D'Zurilla TJ, Black SR, Vivian D, Dowling F, Arnow BA, Manber R, Markowitz JC, Kocsis JH. Social problem solving and depressive symptoms over time: a randomized clinical trial of cognitive-behavioral analysis system of psychotherapy, brief supportive psychotherapy, and pharmacotherapy. J Consult Clin Psychol. 2011 Jun;79(3):342-52. doi: 10.1037/a0023208."}, {'pmid': '19884606', 'type': 'DERIVED', 'citation': 'Kocsis JH, Gelenberg AJ, Rothbaum BO, Klein DN, Trivedi MH, Manber R, Keller MB, Leon AC, Wisniewski SR, Arnow BA, Markowitz JC, Thase ME; REVAMP Investigators. Cognitive behavioral analysis system of psychotherapy and brief supportive psychotherapy for augmentation of antidepressant nonresponse in chronic depression: the REVAMP Trial. Arch Gen Psychiatry. 2009 Nov;66(11):1178-88. doi: 10.1001/archgenpsychiatry.2009.144.'}]}, 'descriptionModule': {'briefSummary': 'This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.', 'detailedDescription': 'Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication.\n\nParticipants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Major depressive episode\n* Depressive symptoms \\> 2 years without remission\n* Hamilton Depression Scale (HAM-D) score \\> 20\n* Fluent in English\n\nExclusion Criteria\n\n* Psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, or eating disorder\n* Serious, unstable, or terminal medical condition\n* Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder\n* Previous treatment with CBASP\n* Previous ineffective treatment with 4 of the medication treatments used in the study\n* Substance abuse\n* Pregnancy\n* Not willing to end other psychiatric treatment'}, 'identificationModule': {'nctId': 'NCT00057551', 'acronym': 'REVAMP', 'briefTitle': 'Research Evaluating the Value of Augmenting Medication With Psychotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'CBASP Augmentation for Treatment of Chronic Depression', 'orgStudyIdInfo': {'id': 'U01MH062475', 'link': 'https://reporter.nih.gov/quickSearch/U01MH062475', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01MH062475', 'link': 'https://reporter.nih.gov/quickSearch/U01MH062475', 'type': 'NIH'}, {'id': 'U01MH061504', 'link': 'https://reporter.nih.gov/quickSearch/U01MH061504', 'type': 'NIH'}, {'id': 'U01MH061562', 'link': 'https://reporter.nih.gov/quickSearch/U01MH061562', 'type': 'NIH'}, {'id': 'U01MH061587', 'link': 'https://reporter.nih.gov/quickSearch/U01MH061587', 'type': 'NIH'}, {'id': 'U01MH061590', 'link': 'https://reporter.nih.gov/quickSearch/U01MH061590', 'type': 'NIH'}, {'id': 'U01MH062465', 'link': 'https://reporter.nih.gov/quickSearch/U01MH062465', 'type': 'NIH'}, {'id': 'U01MH062491', 'link': 'https://reporter.nih.gov/quickSearch/U01MH062491', 'type': 'NIH'}, {'id': 'U01MH062546', 'link': 'https://reporter.nih.gov/quickSearch/U01MH062546', 'type': 'NIH'}, {'id': 'U01MH063481', 'link': 'https://reporter.nih.gov/quickSearch/U01MH063481', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBASP', 'description': 'Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)', 'interventionNames': ['Behavioral: CBASP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brief Supportive Psychotherapy', 'description': 'Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)', 'interventionNames': ['Behavioral: Brief Supportive Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medication Only', 'description': 'Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine', 'interventionNames': ['Drug: Medication Only']}], 'interventions': [{'name': 'Brief Supportive Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'brief supportive psychotherapy', 'armGroupLabels': ['Brief Supportive Psychotherapy']}, {'name': 'CBASP', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioral Analysis System of Psychotherapy'], 'description': 'psychotherapy developed for chronic depression', 'armGroupLabels': ['CBASP']}, {'name': 'Medication Only', 'type': 'DRUG', 'otherNames': ['one of five antidepressants'], 'description': 'antidepressant medication', 'armGroupLabels': ['Medication Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724-5002', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill-Cornell Medical College Payne Whitney Clinic', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY- Stony Brook', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '15213-2600', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'James H Kocsis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'weill cornell mc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}