Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT00177294
Status:
COMPLETED
Last Update Posted:
2012-01-12
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D000079062', 'term': 'Interpersonal Psychotherapy'}, {'id': 'D026661', 'term': 'Clinical Trials Data Monitoring Committees'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D011367', 'term': 'Professional Staff Committees'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reynoldscf@upmc.edu', 'phone': '412-246-6414', 'title': 'Charles F. Reynolds III, MD', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study design does not allow an inference about which specific intervention led to further improvement. Was it simply a dose increase of escitalopram from 10mg to 20mg? Is this intensive contact necessary for improvement?'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Escitalopram Plus Interpersonal Psychotherapy (IPT)', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Escitalopram Plus Depression Care Management (DCM)', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)', 'otherNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Escitalopram Plus Interpersonal Psychotherapy (IPT)', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)'}, {'id': 'OG001', 'title': 'Escitalopram Plus Depression Care Management (DCM)', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '71'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '58'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'We conducted Cox regreassion analyses of time to remission and logistic modeling for rates of remission. We tested group difference in Hamilton depession ratings over time via mixed-effects modeling.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Week 6 or 22', 'description': 'Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Escitalopram Plus Interpersonal Psychotherapy (IPT)', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)'}, {'id': 'FG001', 'title': 'Escitalopram Plus Depression Care Management (DCM)', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were recruited from primary care and specialty mental-health clinics. 377 participants signed consent; 319 started study treatment; 124 were randomized. Of the 124 participants, 60 were randomized to Interpersonal Psychotherapy (IPT) and 59 randomized to Depression Care Management(DCM) without IPT.', 'preAssignmentDetails': '67 enrolled participants were not randomized due to the following reasons: consent withdrawal (41); did not meet eligibility criteria (16); supervening medical problems that precluded participation (4); past history of non-reponse to escitalopram (1); side effects (1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Escitalopram Plus Interpersonal Psychotherapy (IPT)', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)'}, {'id': 'BG001', 'title': 'Escitalopram Plus Depression Care Management (DCM)', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)'}, {'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': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '73.4', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '72.27', 'spread': '7.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-10', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-18', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission', 'timeFrame': 'Measured at Week 6 or 22', 'description': 'Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Elderly', 'Remission', 'Escitalopram', 'Interpersonal Psychotherapy', 'Psychotherapy', 'Caregiving', 'Late-Life'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '20957693', 'type': 'RESULT', 'citation': 'Reynolds CF 3rd, Dew MA, Martire LM, Miller MD, Cyranowski JM, Lenze E, Whyte EM, Mulsant BH, Pollock BG, Karp JF, Gildengers A, Szanto K, Dombrovski AY, Andreescu C, Butters MA, Morse JQ, Houck PR, Bensasi S, Mazumdar S, Stack JA, Frank E. Treating depression to remission in older adults: a controlled evaluation of combined escitalopram with interpersonal psychotherapy versus escitalopram with depression care management. Int J Geriatr Psychiatry. 2010 Nov;25(11):1134-41. doi: 10.1002/gps.2443.'}, {'pmid': '24144505', 'type': 'DERIVED', 'citation': 'Andreescu C, Tudorascu DL, Butters MA, Tamburo E, Patel M, Price J, Karp JF, Reynolds CF 3rd, Aizenstein H. Resting state functional connectivity and treatment response in late-life depression. Psychiatry Res. 2013 Dec 30;214(3):313-21. doi: 10.1016/j.pscychresns.2013.08.007. Epub 2013 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.', 'detailedDescription': 'The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. Participation in the study will last up to 22 weeks.\n\nBecause fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. We will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. Patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus Interpersonal Psychotherapy (IPT, 16 sessions). Changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. This study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery.\n\nFor information on related studies, please follow these links:\n\nhttp://clinicaltrials.gov/show/NCT00178035\n\nhttp://clinicaltrials.gov/show/NCT00178074'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of unipolar major depression\n* Hamilton Rating Scale for Depression (HRSD) (17 item) score of 15 or higher\n* Speaks English\n* Willing to discontinue other psychotropic medications\n* Availability of family member or other caregiver\n* Hearing capacity adequate to respond to a raised conversational voice\n\nExclusion Criteria:\n\n* Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any psychotic disorder\n* Folstein Mini-Mental Status Exam (MMSE) of 17 or lower\n* Suicidal\n* History of treatment non-adherence in other Center protocols\n* History of documented non-response to citalopram in other Center protocols\n* History of non-tolerance to escitalopram therapy'}, 'identificationModule': {'nctId': 'NCT00177294', 'briefTitle': 'Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Geriatric Depression: Getting Better, Getting Well', 'orgStudyIdInfo': {'id': 'R01MH037869-01', 'link': 'https://reporter.nih.gov/quickSearch/R01MH037869-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH037869', 'link': 'https://reporter.nih.gov/quickSearch/R01MH037869', 'type': 'NIH'}, {'id': '0404007'}, {'id': 'DATR A4-GPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)', 'interventionNames': ['Drug: Escitalopram', 'Behavioral: Interpersonal Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management(DCM) without interpersonal psychotherapy (IPT)', 'interventionNames': ['Drug: Escitalopram', 'Behavioral: Clinical Monitoring']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro'], 'description': 'Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.', 'armGroupLabels': ['1', '2']}, {'name': 'Interpersonal Psychotherapy', 'type': 'BEHAVIORAL', 'otherNames': ['IPT'], 'description': '16 sessions of interpersonal psychotherapy (IPT)', 'armGroupLabels': ['1']}, {'name': 'Clinical Monitoring', 'type': 'BEHAVIORAL', 'description': '16 weeks of depression care management(DCM). No psychotherapy will be provided.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Charles F. Reynolds III, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}