{"protocolSection":{"identificationModule":{"nctId":"NCT00918684","orgStudyIdInfo":{"id":"0204005523"},"secondaryIdInfos":[{"id":"R01MH065653-01A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH065653-01A1"}],"organization":{"fullName":"Weill Medical College of Cornell University","class":"OTHER"},"briefTitle":"Aging Brain Changes, Executive Dysfunction and Depression","officialTitle":"Aging White Matter Changes, Executive Dysfunction and Depression","acronym":"FA"},"statusModule":{"statusVerifiedDate":"2017-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2002-12","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2010-05","type":"ACTUAL"},"completionDateStruct":{"date":"2010-05","type":"ACTUAL"},"studyFirstSubmitDate":"2009-06-09","studyFirstSubmitQcDate":"2009-06-10","studyFirstPostDateStruct":{"date":"2009-06-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-02-17","resultsFirstSubmitQcDate":"2017-04-04","resultsFirstPostDateStruct":{"date":"2017-05-12","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-04-04","lastUpdatePostDateStruct":{"date":"2017-05-12","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Weill Medical College of Cornell University","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"},{"name":"Forest Laboratories","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.","detailedDescription":"Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction."},"conditionsModule":{"conditions":["Depression"],"keywords":["Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":116,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"12-week open label with 2 week placebo period (14 weeks total)","interventionNames":["Drug: Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"10mg tab daily","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton Depression Rating Scale.","description":"A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.","timeFrame":"14 weeks (12th week of treatment)"},{"measure":"WHODAS-II Disability Scale","description":"A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.","timeFrame":"14 weeks (12th week of treatment)"},{"measure":"Stroop Color-Word Test","description":"A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.","timeFrame":"14 weeks (12th week of treatment)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).\n2. Diagnosis: Major depression, unipolar (by DSM-IV criteria); or, for control subjects, no diagnosis of major depression, no history of depression or other psychiatric conditions.\n3. Severity of depression: A 24-Item HDRS above 19; Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores below and above 24 (1 SD below the median of our normal elderly sample).\n\nExclusion Criteria:\n\n1. Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS; 51).\n2. High suicide risk, i.e. intent or plan to attempt suicide in near future.\n3. Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.\n4. Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).\n5. History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).\n6. Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.\n7. Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids.\n8. Failure to respond to an adequate trial of escitalopram (10 mg/day or more for 6 weeks or longer) during the current or previous depressive episodes.\n9. Current involvement in psychotherapy.\n10. History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.\n11. Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion.\n12. Inability to speak English.\n13. Aphasia.\n14. Residence outside a 45-minute drive from Cornell's clinical facilities.\n15. Patients taking MAOI's and Fluoxetine will be excluded.","healthyVolunteers":false,"sex":"ALL","minimumAge":"60 Years","maximumAge":"85 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"George S Alexopoulos, MD","affiliation":"Weill Medical College of Cornell University","role":"PRINCIPAL_INVESTIGATOR"}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"116 participants were consented and enrolled. 10 of these subjects did not participate in the washout/placebo phase.","recruitmentDetails":"Participant Flow of the Overall Study","groups":[{"id":"FG000","title":"Escitalopram","description":"12-week open label with 2 week placebo period (14 weeks total)\n\nEscitalopram: 10mg tab daily"}],"periods":[{"title":"Two Week Drug Washout and Placebo Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"106"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"90"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Placebo Reponder","reasons":[{"groupId":"FG000","numSubjects":"16"}]}]},{"title":"Treatment Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"90"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"65"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"}]}],"dropWithdraws":[{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"8"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All subjects who entered the treatment phase","groups":[{"id":"BG000","title":"Escitalopram","description":"12-week open label with 2 week placebo period (14 weeks total)\n\nEscitalopram: 10mg tab daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"90"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"21"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"69"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"70.82","spread":"6.76"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"51"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"39"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"89"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"12"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"75"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"90"}]}]}]},{"title":"Hamilton Scale for Depression","description":"The Hamilton Scale for Depression 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"21.21","spread":"4.51"}]}]}]},{"title":"Mini Mental Status Examination (MMSE)","description":"MMSE total scores range from 0-30. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.08","spread":"1.64"}]}]}]},{"title":"WHODAS-II Disability Score","description":"WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34.64","spread":"10.56"}]}]}]},{"title":"Stroop Color-Word Test","description":"Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.77","spread":"10.63"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton Depression Rating Scale.","description":"A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"14 weeks (12th week of treatment)","groups":[{"id":"OG000","title":"Escitalopram","description":"12-week open label with 2 week placebo period (14 weeks total)\n\nEscitalopram: 10mg tab daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.09","spread":"5.93"}]}]}]},{"type":"PRIMARY","title":"WHODAS-II Disability Scale","description":"A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"14 weeks (12th week of treatment)","groups":[{"id":"OG000","title":"Escitalopram","description":"12-week open label with 2 week placebo period (14 weeks total)\n\nEscitalopram: 10mg tab daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"31.43","spread":"9.14"}]}]}]},{"type":"PRIMARY","title":"Stroop Color-Word Test","description":"A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"14 weeks (12th week of treatment)","groups":[{"id":"OG000","title":"Escitalopram","description":"12-week open label with 2 week placebo period (14 weeks total)\n\nEscitalopram: 10mg tab daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"90"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.63","spread":"10.2"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"1","timeFrame":"Up to 14 weeks","description":"Clinicaltrials.gov definitions apply.","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"12-week open label with 2 week placebo period (14 weeks total)\n\nEscitalopram: 10mg tab daily","deathsNumAffected":0,"deathsNumAtRisk":90,"seriousNumAffected":6,"seriousNumAtRisk":90,"otherNumAffected":55,"otherNumAtRisk":90}],"seriousEvents":[{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90}]},{"term":"Wheezing","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90}]},{"term":"Colonic hemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":90}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90}]}],"otherEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":90}]},{"term":"Anorgasmia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 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12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90}]},{"term":"Nasal congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":90}]},{"term":"Cyst","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.1","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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