{"protocolSection":{"identificationModule":{"nctId":"NCT00902564","orgStudyIdInfo":{"id":"12132A"},"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Escitalopram in Patients With Generalized Anxiety Disorder","officialTitle":"Efficacy and Safety of Escitalopram in Patients With Generalized 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":"2011-03-14","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 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), 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 8 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":["Generalized Anxiety Disorder"],"keywords":["Generalized Anxiety Disorder","GAD","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 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)","description":"The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.","timeFrame":"baseline and 8 weeks"}],"secondaryOutcomes":[{"measure":"Effect of Escitalopram After 8 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 8 weeks"},{"measure":"Effect of Escitalopram After 8 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 8 weeks"},{"measure":"Percentage of Patients Who Responded to Escitalopram After 8 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 8 weeks"},{"measure":"Percentage of Patients Who Achieved Remission After 8 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 8 weeks"},{"measure":"Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment.","timeFrame":"baseline and 8 weeks"},{"measure":"Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment.","timeFrame":"baseline and 8 weeks"},{"measure":"Effect of Escitalopram After 8 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 scale, on which 0 = normal functioning and 10 = severe functional impairment.","timeFrame":"baseline and 8 weeks"},{"measure":"Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score","description":"The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.","timeFrame":"baseline and 8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* The patient suffers from GAD, diagnosed according to ICD-10 (International Classification of Diseases)\n* The patient meets criteria as set out 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 via H. 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":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"}]}]}]},"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":"37.3","spread":"12"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"19"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"}]}]}]},{"title":"Hamilton Anxiety Scale (HAMA)","description":"The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31.1","spread":"5.3"}]}]}]},{"title":"Clinical Global Impression Severity (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).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.5","spread":"0.6"}]}]}]},{"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 scale, 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":"6.8","spread":"1.6"}]}]}]},{"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 scale, 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":"6.1","spread":"2.0"}]}]}]},{"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 scale, 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":"6.8","spread":"2.5"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)","description":"The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"baseline and 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.1","spread":"6.2"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 8 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 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.2","spread":"0.4"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 8 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 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.9","spread":"0.7"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Who Responded to Escitalopram After 8 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 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Who Achieved Remission After 8 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 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"85.7"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 8 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 scale, 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 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"2.0"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 8 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 scale, 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 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.2","spread":"1.9"}]}]}]},{"type":"SECONDARY","title":"Effect of Escitalopram After 8 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 scale, 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 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"2.4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score","description":"The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.","populationDescription":"Observed Cases (OC)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"baseline and 8 weeks","groups":[{"id":"OG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67.9"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"8 weeks","eventGroups":[{"id":"EG000","title":"Escitalopram (5 to 20 mg Oral Tablets Daily)","seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":13,"otherNumAtRisk":30}],"otherEvents":[{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.1)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.1)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.1)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.1)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]},{"term":"Hyperhidrosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.1)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"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 and/or intellectual property rights. The Investigator shall send any manuscript and/or 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 and/or 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":"D000098647","term":"Generalized Anxiety Disorder"}],"ancestors":[{"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}