{"protocolSection":{"identificationModule":{"nctId":"NCT00215137","orgStudyIdInfo":{"id":"Pro00013150"},"secondaryIdInfos":[{"id":"5731-04-4R0","type":"OTHER","domain":"Duke legacy protocol number"}],"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder","officialTitle":"Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder"},"statusModule":{"statusVerifiedDate":"2013-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-10"},"primaryCompletionDateStruct":{"date":"2009-01","type":"ACTUAL"},"completionDateStruct":{"date":"2009-03","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-20","studyFirstSubmitQcDate":"2005-09-20","studyFirstPostDateStruct":{"date":"2005-09-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-04-15","resultsFirstSubmitQcDate":"2013-08-22","resultsFirstPostDateStruct":{"date":"2013-10-29","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-07-14","lastUpdatePostDateStruct":{"date":"2014-07-23","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Duke University","class":"OTHER"},"collaborators":[{"name":"Forest Laboratories","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.","detailedDescription":"OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(SSRI) drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients.\n\nThis study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2."},"conditionsModule":{"conditions":["OCD"],"keywords":["OCD","SSRI","escitalopram","relapse"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":14,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Open Label Escitalopram 10-20 mg/daily","type":"EXPERIMENTAL","description":"Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.","interventionNames":["Drug: escitalopram"]},{"label":"Randomizationn Placebo 10-20 mg daily","type":"PLACEBO_COMPARATOR","description":"Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \\< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).","interventionNames":["Drug: Placebo ( sugar pill)"]},{"label":"Randomization Escitalopram 10-20 mg/daily","type":"ACTIVE_COMPARATOR","description":"Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \\< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).","interventionNames":["Drug: escitalopram"]}],"interventions":[{"type":"DRUG","name":"escitalopram","description":"Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.","armGroupLabels":["Open Label Escitalopram 10-20 mg/daily","Randomization Escitalopram 10-20 mg/daily"],"otherNames":["Lexapro"]},{"type":"DRUG","name":"Placebo ( sugar pill)","description":"Placebo Comparator in double.blind phase.","armGroupLabels":["Randomizationn Placebo 10-20 mg daily"],"otherNames":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Yale Brown Obsessive Compulsive Scale","description":"The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.","timeFrame":"Open Label Phase Baseline,Randomization Phase Baseline or Beginning"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of OCD\n* A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits\n\nExclusion Criteria:\n\n* Lifetime history of psychosis or cognitive dysfunction due to a general medical condition or substance use\n* A primary diagnosis of another Axis I psychiatric disorder\n* Alcohol or other substance abuse or dependence within the last 6 months\n* Unstable medical condition\n* Clinically significant laboratory abnormality\n* Failure of a previous 10-week trial of citalopram of at least 40 mg/day or escitalopram 20 mg/day\n* Active suicidality\n* History of violent behavior in the past year or current risk of serious violence\n* A history of sensitivity to citalopram or escitalopram\n* Use of other investigational drugs within 30 days of baseline or other psychotropic drugs or herbs within 14 days of baseline (28 days for fluoxetine)\n* Need for concurrent psychotherapeutic intervention\n* Pregnant or lactating females.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Wei M. Zhang, MD, PhD","affiliation":"Duke University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","zip":"27710","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}}]},"referencesModule":{"references":[{"type":"RESULT","citation":"C. Joseph Wang, M.D., Ph.D.; Jonathan R. Davidson, M.D.; Kathryn M. Connor, M.D.;Weihui Li1, M.D.,Ph.D. and Wei Zhang, M.D., Ph.D. Unpublished Manuscript"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Open Label Escitalopram","description":"Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects."},{"id":"FG001","title":"Randomization Placebo","description":"Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \\< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7)."},{"id":"FG002","title":"Randomization Escitalopram","description":"Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \\< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7)."}],"periods":[{"title":"Open Label Escitalopram","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Randomization Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Only the open label treatment phase is being reported per reviewer's instructions. The other arms are for the second phase of the study.","groups":[{"id":"BG000","title":"Open Label Escitalopram","description":"Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"14"}]}],"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":"14"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.14","spread":"13.27"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"5"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"14"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Yale Brown Obsessive Compulsive Scale","description":"The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Open Label Phase Baseline,Randomization Phase Baseline or Beginning","groups":[{"id":"OG000","title":"Open Label Escitalopram","description":"Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post baseline sample."},{"id":"OG001","title":"Randomization Placebo","description":"Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \\< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post beginning of the study phase sample."},{"id":"OG002","title":"Randomization Escitalopram","description":"Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \\< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from beginning of the study phase sample."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"Beginning of Study Phase","categories":[{"measurements":[{"groupId":"OG000","value":"24.79","spread":"4.48"},{"groupId":"OG001","value":"12.71","spread":"6.13"},{"groupId":"OG002","value":"16.00","spread":"6.96"}]}]},{"title":"End of Study Phase","categories":[{"measurements":[{"groupId":"OG000","value":"15.36","spread":"7"},{"groupId":"OG001","value":"20.17","spread":"11.57"},{"groupId":"OG002","value":"15.8","spread":"7.79"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0002","statisticalMethod":"Wilcoxon (Mann-Whitney)","ciPctValue":"95","ciNumSides":"TWO_SIDED"},{"groupIds":["OG001","OG002"],"groupDescription":"A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".0417","statisticalMethod":"Wilcoxon Rank Sum Test","ciPctValue":"95","ciNumSides":"TWO_SIDED"}]}]},"adverseEventsModule":{"frequencyThreshold":"1","eventGroups":[{"id":"EG000","title":"Open Label Escitalopram","description":"Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.","seriousNumAffected":0,"seriousNumAtRisk":14,"otherNumAffected":0,"otherNumAtRisk":14},{"id":"EG001","title":"Randomization Placebo","description":"Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \\< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).","seriousNumAffected":0,"seriousNumAtRisk":7,"otherNumAffected":0,"otherNumAtRisk":7},{"id":"EG002","title":"Randomization Escitalopram","description":"Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \\< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).","seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":0,"otherNumAtRisk":5}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Wei Zhang MD","organization":"Duke University Medical Center Dept of Psychiatry","email":"wei.zhang@duke.edu","phone":"919 684 5645"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D012008","term":"Recurrence"}],"ancestors":[{"id":"D020969","term":"Disease Attributes"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"},{"id":"D000073893","term":"Sugars"}],"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":"D002241","term":"Carbohydrates"}]}},"hasResults":true}