{"protocolSection":{"identificationModule":{"nctId":"NCT00902226","orgStudyIdInfo":{"id":"12133A"},"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Escitalopram in Patients With Social Anxiety Disorder","officialTitle":"Efficacy and Safety of Escitalopram in Patients With Social Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia"},"statusModule":{"statusVerifiedDate":"2011-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-03"},"primaryCompletionDateStruct":{"date":"2009-12","type":"ACTUAL"},"completionDateStruct":{"date":"2010-03","type":"ACTUAL"},"studyFirstSubmitDate":"2009-05-14","studyFirstSubmitQcDate":"2009-05-14","studyFirstPostDateStruct":{"date":"2009-05-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-03-24","resultsFirstSubmitQcDate":"2011-05-11","resultsFirstPostDateStruct":{"date":"2011-06-10","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-05-11","lastUpdatePostDateStruct":{"date":"2011-06-10","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"H. Lundbeck A/S","oldOrganization":"H. Lundbeck A/S"},"leadSponsor":{"name":"H. Lundbeck A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.","detailedDescription":"The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 12 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC)."},"conditionsModule":{"conditions":["Social Anxiety Disorder"],"keywords":["Social Anxiety Disorder","SAD","Antidepressant","Anxiolytic"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","interventionNames":["Drug: Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"Flexible-dosed (5 to 20 mg Oral Tablets Daily)","armGroupLabels":["Escitalopram"],"otherNames":["Cipralex, Lexapro"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)","description":"The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).","timeFrame":"baseline and 12 weeks"}],"secondaryOutcomes":[{"measure":"Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)","description":"The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).","timeFrame":"baseline and 12 weeks"},{"measure":"Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2","description":"The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).","timeFrame":"baseline and 12 weeks"},{"measure":"Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2","description":"The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).","timeFrame":"baseline and 12 weeks"},{"measure":"Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","timeFrame":"baseline and 12 weeks"},{"measure":"Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","timeFrame":"baseline and 12 weeks"},{"measure":"Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","timeFrame":"baseline and 12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* The patient suffers from SAD, diagnosed according to ICD-10 (International Classification of Diseases)\n* The patient meets criteria set in the national SPC for escitalopram\n* The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs\n\nExclusion Criteria:\n\n* The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10\n* The patient has contraindications to escitalopram\n* The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram\n* The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance\n* The patient is pregnant or breast-feeding\n* The patient, if a woman of childbearing potential, is not using adequate contraception","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Email contact viaH. Lundbeck A/S viaH. Lundbeck A/S","affiliation":"LundbeckClinicalTrials@lundbeck.com","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"RU001","city":"Moscow","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"30"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"}]}],"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":"30"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.3","spread":"12.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"24"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"6"}]}]}]},{"title":"CGI Severity Score","description":"The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.3","spread":"1.0"}]}]}]},{"title":"Sheehan Disability Scale (SDS) Work","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.9","spread":"1.5"}]}]}]},{"title":"Sheehan Disability Scale (SDS) Family","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.3","spread":"2.1"}]}]}]},{"title":"Sheehan Disability Scale (SDS) Social","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.0","spread":"1.5"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)","description":"The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"baseline and 12 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"0.8"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)","description":"The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"baseline and 12 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.6","spread":"0.9"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2","description":"The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"baseline and 12 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"80"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2","description":"The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"baseline and 12 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","populationDescription":"Due to data being unavailable, 22 participants were analysed for this outcome, in contrast with 30 participants for the other outcomes.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"baseline and 12 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.8","spread":"1.9"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"baseline and 12 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"2.1"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social","description":"The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"baseline and 12 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.5","spread":"2.1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)","seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":16,"otherNumAtRisk":30}],"otherEvents":[{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]},{"term":"Muscle spasticity","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"No results can be made public before appropriate steps by Lundbeck to secure patents / intellectual property rights. The Investigator shall send any manuscript / public presentation to Lundbeck at least 1 month before submission for publication. If Lundbeck finds matters requiring patents or the like, the Investigator shall delay publication / public presentation for an additional 3 months."},"pointOfContact":{"title":"Study Director","organization":"H. Lundbeck A/S","email":"LundbeckClinicalTrials@lundbeck.com","phone":"email contact via","phoneExt":"Lundbeck"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D000072861","term":"Phobia, Social"}],"ancestors":[{"id":"D010698","term":"Phobic Disorders"},{"id":"D001008","term":"Anxiety Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"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}