{"protocolSection":{"identificationModule":{"nctId":"NCT00220701","orgStudyIdInfo":{"id":"LXP-MD-34"},"organization":{"fullName":"St. Luke's-Roosevelt Hospital Center","class":"OTHER"},"briefTitle":"Escitalopram in the Treatment of Dysthymic Disorder, Double Blind","officialTitle":"Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder"},"statusModule":{"statusVerifiedDate":"2007-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2002-06"},"primaryCompletionDateStruct":{"date":"2008-11","type":"ACTUAL"},"completionDateStruct":{"date":"2009-01","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-21","studyFirstSubmitQcDate":"2005-09-21","studyFirstPostDateStruct":{"date":"2005-09-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-11-19","resultsFirstSubmitQcDate":"2014-11-19","resultsFirstPostDateStruct":{"date":"2014-11-25","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-10-13","lastUpdatePostDateStruct":{"date":"2015-11-11","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"St. Luke's-Roosevelt Hospital Center","class":"OTHER"},"collaborators":[{"name":"Forest Laboratories","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.\n\nIt is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning.","detailedDescription":"This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of Dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.\n\nFlexible dosing to a maximum of 40 mg per day will be used. It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning. Blood cytokine levels will also be measured at weeks 0, 12, and 24 to determine their relationship to depressive symptoms and improvement."},"conditionsModule":{"conditions":["Dysthymic Disorder"],"keywords":["Dysthymic Disorder","Depression","Chronic Depression","Escitalopram"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":36,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"escitalopram","type":"EXPERIMENTAL","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.","interventionNames":["Drug: Lexapro (escitalopram)"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"inactive comparator","interventionNames":["Drug: Lexapro (escitalopram)"]}],"interventions":[{"type":"DRUG","name":"Lexapro (escitalopram)","description":"antidepressant drug selective serotonin reuptake inhibitor (SSRI)","armGroupLabels":["Placebo","escitalopram"],"otherNames":["lexapro","escitalopram","s-citalopram","d-citalopram"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton-Depression Rating Scale (HDRS-24 Items)","description":"Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\\>50% decrease) Remission (score\\<=7)","timeFrame":"Week 12"},{"measure":"Hamilton-Depression Rating Scale (HDRS-24 Items)","description":"Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\\>50% decrease) Remission (score\\<=7)","timeFrame":"Baseline"}],"secondaryOutcomes":[{"measure":"Clinical Global Impressions - Severity (CGI-S)","description":"Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)","timeFrame":"Week 12"},{"measure":"Beck Depression Inventory (BDI)","description":"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.","timeFrame":"Baseline"},{"measure":"Clinical Global Impressions - Severity (CGI-S)","description":"Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)","timeFrame":"Baseline"},{"measure":"Beck Depression Inventory (BDI)","description":"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.","timeFrame":"Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male and female outpatients 18-65 years of age.\n* Patients with a Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnosis of dysthymic disorder.\n* Subject must be considered reliable.\n* Patients will have a total of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.\n\nExclusion Criteria:\n\n* Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.\n* Patients who plan to produce a pregnancy within the next 6 months, or patients who are pregnant or nursing women.\n* Patients who have a history of non-response to two or more sufficient trials of antidepressant medication (as defined in Table 1).\n* Patients with a principal diagnosis meeting DSM-IV criteria for:\n\n  * Major Depressive Disorder, current\n  * Bipolar Disorder or cyclothymia .Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified.\n  * Anorexia Nervosa or Bulimia\n* Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol, excluding caffeine and tobacco.\n* Patients who have taken psychotropic medication or herbal preparations with putative psychotropic effects within 7 days prior to Visit 2. Patients taking a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) must have a washout period of 14 days prior to visit 2, and patients taking fluoxetine must have a washout period of at least 4 weeks prior to Visit 2.\n* Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:\n\n  * Report of having a specific plan for killing themselves\n  * A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors)\n  * A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of \\> 1 week's dose of medication.\n* Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic o neurologic disease, or any clinically significant laboratory abnormality.\n* Patients who lack the capacity to proved informed consent\n* 50% or greater decrease in HDRS total score from visit 2 to visit 3 or a CGI-Improvement score of 1 (\"very much improved\") or 2 (\"much improved\") at Visit 3\n* Patients receiving CGI Improvement scores of 6 (\"much worse\") or 7 (\"very much worse\") for two consecutive visits will be withdrawn from the study.\n* Patients who meet criteria for Major Depressive Disorder at any time during the course of the study will be withdrawn from the study.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"David J. Hellerstein, MD","affiliation":"St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center","city":"New York","state":"New York","zip":"10019","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]},"referencesModule":{"references":[{"pmid":"21811192","type":"RESULT","citation":"Hellerstein DJ, Batchelder ST, Hyler S, Arnaout B, Toba C, Benga I, Gangure D. Escitalopram versus placebo in the treatment of dysthymic disorder. Int Clin Psychopharmacol. 2010 May;25(3):143-8. doi: 10.1097/YIC.0b013e328333c35e."}],"seeAlsoLinks":[{"label":"For more information about our program and this study click here.","url":"http://www.DepressionNY.com"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"FG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"BG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"34"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.88","spread":"9.92"},{"groupId":"BG001","value":"43.59","spread":"11.33"},{"groupId":"BG002","value":"43.74","spread":"10.49"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"17"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"17"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton-Depression Rating Scale (HDRS-24 Items)","description":"Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\\>50% decrease) Remission (score\\<=7)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"OG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.88","spread":"5.83"},{"groupId":"OG001","value":"16.41","spread":"6.34"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.10","statisticalMethod":"Repeated Measures ANOVA","paramType":"F statistics","paramValue":"2.82","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Clinical Global Impressions - Severity (CGI-S)","description":"Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"OG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.35","spread":"0.93"},{"groupId":"OG001","value":"3.41","spread":"1.06"}]}]}]},{"type":"SECONDARY","title":"Beck Depression Inventory (BDI)","description":"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"OG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.00","spread":"5.21"},{"groupId":"OG001","value":"16.25","spread":"5.12"}]}]}]},{"type":"PRIMARY","title":"Hamilton-Depression Rating Scale (HDRS-24 Items)","description":"Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\\>50% decrease) Remission (score\\<=7)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"OG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.82","spread":"5.75"},{"groupId":"OG001","value":"24.41","spread":"6.25"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impressions - Severity (CGI-S)","description":"Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"OG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.06","spread":"0.24"},{"groupId":"OG001","value":"4.06","spread":"0.43"}]}]}]},{"type":"SECONDARY","title":"Beck Depression Inventory (BDI)","description":"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"},{"id":"OG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.76","spread":"4.91"},{"groupId":"OG001","value":"10.00","spread":"5.16"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)","seriousNumAffected":0,"seriousNumAtRisk":17,"otherNumAffected":15,"otherNumAtRisk":17},{"id":"EG001","title":"Placebo","description":"inactive comparator\n\nLexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)","seriousNumAffected":0,"seriousNumAtRisk":17,"otherNumAffected":14,"otherNumAtRisk":15}],"otherEvents":[{"term":"Upset stomach","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":17},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":15}]},{"term":"Decreased Libido","organSystem":"Reproductive system and breast disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":17},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":15}]},{"term":"Delayed Ejection","organSystem":"Reproductive system and breast disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":15}]},{"term":"Lightheadedness","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":17},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":15}]},{"term":"Other","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":17},{"groupId":"EG001","numEvents":10,"numAffected":10,"numAtRisk":15}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Small double blinded study with limited power."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"David Hellerstein MD","organization":"NY State Psychiatric Institute","email":"hellers@nyspi.columbia.edu","phone":"6467748000"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D019263","term":"Dysthymic Disorder"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"},{"id":"D003909","term":"Dexetimide"}],"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":"D010881","term":"Piperidones"},{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"}]}},"hasResults":true}