{"protocolSection":{"identificationModule":{"nctId":"NCT01103180","orgStudyIdInfo":{"id":"MH084904"},"organization":{"fullName":"University of Chicago","class":"OTHER"},"briefTitle":"Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder","officialTitle":"SSRIs and Self-harm in Borderline Personality Disorder"},"statusModule":{"statusVerifiedDate":"2019-06","overallStatus":"TERMINATED","whyStopped":"Funding withdrawn due to inability to accrue","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-09"},"primaryCompletionDateStruct":{"date":"2014-11","type":"ACTUAL"},"completionDateStruct":{"date":"2014-11","type":"ACTUAL"},"studyFirstSubmitDate":"2010-04-12","studyFirstSubmitQcDate":"2010-04-13","studyFirstPostDateStruct":{"date":"2010-04-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-07-24","resultsFirstSubmitQcDate":"2019-06-12","resultsFirstPostDateStruct":{"date":"2019-06-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-06-12","lastUpdatePostDateStruct":{"date":"2019-06-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Chicago","class":"OTHER"},"collaborators":[{"name":"Temple University","class":"OTHER"},{"name":"Northwestern University","class":"OTHER"},{"name":"University of Southern Mississippi","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The goal of this study is to examine the effectiveness the selective serotonin reuptake inhibitor (SSRI) escitalopram (also known by the trade name \"Lexapro\") in reducing desire to self-harm and actual self-harming among young adults with borderline personality disorder who are also currently depressed. Subjects will receive either escitalopram or placebo for eight weeks. During this time subjects will be make weekly visits to see the psychiatrist and record their thoughts and feelings several times each day using an electronic diary."},"conditionsModule":{"conditions":["Borderline Personality Disorder"],"keywords":["Selective Serotonin Reuptake Inhibitor","Escitalopram","Borderline Personality Disorder","Major Depressive Disorder","Self-harm"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":70,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)","interventionNames":["Drug: Escitalopram"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Inert placebo (sugar pill) taken daily for eight weeks","interventionNames":["Drug: Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)","armGroupLabels":["Escitalopram","Placebo"],"otherNames":["Lexapro"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Self-harm Ideation","description":"Self-harm ideation was measured by electronic diaries (EMA) up to four times a day. Each time a person completed an EMA diary they were asked to rate their urge to hurt themselves on a 5 point scale ( 0 to 4) pad where 0 is not at all, 2 is moderately and 4 is extremely strong.","timeFrame":"pre-treatment (week 0) to post-treatment (end of week 8)"}],"secondaryOutcomes":[{"measure":"Depressive Symptoms","description":"Depressive symptoms was assessed via (a) electronic diary (i.e. sum of eight POMS-D items: sad, unhappy, blue, hopeless, discouraged, miserable, helpless and worthless rated using 0-4 scale above) and (b) weekly interview(Hamilton depression rating)","timeFrame":"baseline (week 0) and post treatment (week 8)."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of Borderline Personality Disorder\n* Current Major Depression\n\nExclusion Criteria:\n\n* Past 2 months SSRI use\n* Past 6 months non-SSRI antidepressant use\n* Past 2 months initiation of psychotherapy\n* Lifetime bipolar disorder, organic disorder, psychotic disorder\n* Current alcohol or drug dependence\n* Current severe suicidal / homicidal ideation necessitating immediate medical intervention\n* Currently pregnancy or nursing\n* Unable or unwilling to cooperate with study protocol","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"40 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Michael S McCloskey, Ph.D","affiliation":"Temple University (primary) / University of Chicago","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Emil F Coccaro, M.D.","affiliation":"University of Chicago","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"The University of Chicago Hospitals","city":"Chicago","state":"Illinois","zip":"60637","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}}]},"referencesModule":{"references":[{"pmid":"36375174","type":"DERIVED","citation":"Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Escitalopram","description":"10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"},{"id":"FG001","title":"Placebo","description":"Inert placebo (sugar pill) taken daily for eight weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"35"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"14"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"21"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"},{"id":"BG001","title":"Placebo","description":"Inert placebo (sugar pill) taken daily for eight weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"70"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"30.4","spread":"9.9"},{"groupId":"BG001","value":"27.3","spread":"8.8"},{"groupId":"BG002","value":"28.9","spread":"9.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"52"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"18"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Self-harm Ideation","description":"Self-harm ideation was measured by electronic diaries (EMA) up to four times a day. Each time a person completed an EMA diary they were asked to rate their urge to hurt themselves on a 5 point scale ( 0 to 4) pad where 0 is not at all, 2 is moderately and 4 is extremely strong.","populationDescription":"Data was not collected because the study was terminated.","reportingStatus":"POSTED","timeFrame":"pre-treatment (week 0) to post-treatment (end of week 8)","groups":[{"id":"OG000","title":"Escitalopram","description":"10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)\n\nEscitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"},{"id":"OG001","title":"Placebo","description":"Inert placebo (sugar pill) taken daily for eight weeks\n\nEscitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Depressive Symptoms","description":"Depressive symptoms was assessed via (a) electronic diary (i.e. sum of eight POMS-D items: sad, unhappy, blue, hopeless, discouraged, miserable, helpless and worthless rated using 0-4 scale above) and (b) weekly interview(Hamilton depression rating)","populationDescription":"Data was not collected because the study was terminated.","reportingStatus":"POSTED","timeFrame":"baseline (week 0) and post treatment (week 8).","groups":[{"id":"OG000","title":"Escitalopram","description":"10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)\n\nEscitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"},{"id":"OG001","title":"Placebo","description":"Inert placebo (sugar pill) taken daily for eight weeks\n\nEscitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)\n\nEscitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)","seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":0,"otherNumAtRisk":13},{"id":"EG001","title":"Placebo","description":"Inert placebo (sugar pill) taken daily for eight weeks\n\nEscitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)","seriousNumAffected":0,"seriousNumAtRisk":14,"otherNumAffected":0,"otherNumAtRisk":14}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Early study termination due to recruitment difficulties leading to none of subjects analyzed"},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Emil Coccaro","organization":"University of Chicago","email":"ecoccaro@yoda.bsd.uchicago.edu","phone":"773-834-4083"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001883","term":"Borderline Personality Disorder"},{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D016728","term":"Self-Injurious Behavior"}],"ancestors":[{"id":"D010554","term":"Personality Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"}],"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"}]}},"hasResults":true}