{"protocolSection":{"identificationModule":{"nctId":"NCT00105586","orgStudyIdInfo":{"id":"R01MH070547","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH070547"},"secondaryIdInfos":[{"id":"R01MH070547","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH070547"}],"organization":{"fullName":"University of Pittsburgh","class":"OTHER"},"briefTitle":"Drug Therapy for Generalized Anxiety Disorder Among the Elderly","officialTitle":"Pharmacotherapy of Late-Life Generalized Anxiety Disorder"},"statusModule":{"statusVerifiedDate":"2017-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-12"},"primaryCompletionDateStruct":{"date":"2008-01","type":"ACTUAL"},"completionDateStruct":{"date":"2008-04","type":"ACTUAL"},"studyFirstSubmitDate":"2005-03-15","studyFirstSubmitQcDate":"2005-03-15","studyFirstPostDateStruct":{"date":"2005-03-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-08-03","resultsFirstSubmitQcDate":"2017-05-04","resultsFirstPostDateStruct":{"date":"2017-05-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-05-04","lastUpdatePostDateStruct":{"date":"2017-05-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Eric Lenze","investigatorTitle":"Professor of Psychiatry","investigatorAffiliation":"University of Pittsburgh"},"leadSponsor":{"name":"University of Pittsburgh","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD in elderly individuals.","detailedDescription":"GAD is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. GAD is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. Serotonin is a neurotransmitter that helps regulate mood and emotions; increased levels of serotonin have been shown to reduce anxiety. Standard treatment for GAD typically involves selective serotonin reuptake inhibitors (SSRIs), drugs that reduce serotonin re-entry into nerve cells. Escitalopram is an SSRI that is well tolerated and highly specific for the serotonin transporter (SERT). The primary aim of this study is to examine the efficacy of escitalopram in reducing anxiety symptoms among elderly GAD patients. Additional aims include examining the efficacy of escitalopram for improving function, quality of life, and neuropsychological functioning, and examining whether genetic variation in the SERT gene influences these participants' response to treatment.\n\nParticipants will be randomly assigned to receive either escitalopram or placebo for 12 weeks (there is also a 12 week open label extension in which all participants will receive escitalopram). Participants will have weekly/biweekly study visits; during these visits, participants will complete self-report questionnaires on functional ability and anxiety symptoms. Blood collection and cognitive testing through various tasks will also occur."},"conditionsModule":{"conditions":["Anxiety Disorders","Generalized Anxiety Disorder"],"keywords":["Anxiety","Elderly","Aged","Serotonin Reuptake Inhibitors","SSRI","SERT"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":177,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram (1)","type":"EXPERIMENTAL","description":"Escitalopram","interventionNames":["Drug: Escitalopram"]},{"label":"Placebo (2)","type":"PLACEBO_COMPARATOR","description":"Placebo","interventionNames":["Drug: Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram.","armGroupLabels":["Escitalopram (1)","Placebo (2)"],"otherNames":["Lexapro"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Response Using Clinical Global Impressions-Improvement Scale (CGI-I)","description":"Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).","timeFrame":"Measured at Weeks 1-12"}],"secondaryOutcomes":[{"measure":"Quality of Life","description":"Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).","timeFrame":"Measured at Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of at least moderately severe generalized anxiety disorder (GAD)\n\nExclusion Criteria:\n\n* Serious suicide risk or psychiatric instability that would affect study participation\n* Dementia\n* Substance abuse, such as alcoholism, within 6 months prior to study entry\n* Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder\n* Unstable medical conditions that would preclude the use of escitalopram\n* Use of certain psychotropics that can not be safely tapered or discontinued for at least 2 weeks prior to and during the study\n* Use of neuroleptics that are absorbed over a prolonged period of time within 6 weeks prior to study entry","healthyVolunteers":false,"sex":"ALL","minimumAge":"60 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Eric J. Lenze, MD","affiliation":"University of Pittsburgh Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","zip":"15213","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}}]},"referencesModule":{"references":[{"pmid":"19155456","type":"RESULT","citation":"Lenze EJ, Rollman BL, Shear MK, Dew MA, Pollock BG, Ciliberti C, Costantino M, Snyder S, Shi P, Spitznagel E, Andreescu C, Butters MA, Reynolds CF 3rd. Escitalopram for older adults with generalized anxiety disorder: a randomized controlled trial. JAMA. 2009 Jan 21;301(3):295-303. doi: 10.1001/jama.2008.977."},{"pmid":"21727232","type":"RESULT","citation":"Butters MA, Bhalla RK, Andreescu C, Wetherell JL, Mantella R, Begley AE, Lenze EJ. Changes in neuropsychological functioning following treatment for late-life generalised anxiety disorder. Br J Psychiatry. 2011 Sep;199(3):211-8. doi: 10.1192/bjp.bp.110.090217. Epub 2011 Jul 4."},{"pmid":"32991792","type":"DERIVED","citation":"Altmann H, Stahl ST, Gebara MA, Lenze EJ, Mulsant BH, Blumberger DM, Reynolds CF 3rd, Karp JF. Coprescribed Benzodiazepines in Older Adults Receiving Antidepressants for Anxiety and Depressive Disorders: Association With Treatment Outcomes. J Clin Psychiatry. 2020 Sep 29;81(6):20m13283. doi: 10.4088/JCP.20m13283."},{"pmid":"21105279","type":"DERIVED","citation":"Lenze EJ, Goate AM, Nowotny P, Dixon D, Shi P, Bies RR, Lotrich FK, Rollman BL, Shear MK, Thompson PA, Andreescu C, Pollock BG. Relation of serotonin transporter genetic variation to efficacy of escitalopram for generalized anxiety disorder in older adults. J Clin Psychopharmacol. 2010 Dec;30(6):672-7. doi: 10.1097/jcp.0b013e3181fc2bef."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"interested investigators should contact the PI directly via email."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"78 excluded from randomization due to ineligibility and/or refusal; 2 excluded after randomization but did not start treatment","recruitmentDetails":"257 subjects consented (177 randomized and received treatment)","groups":[{"id":"FG000","title":"Placebo","description":"Participants will receive a placebo."},{"id":"FG001","title":"Escitalopram","description":"Participants will receive escitalopram."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"85"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"75"},{"groupId":"FG001","numSubjects":"69"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"13"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Participants will receive a placebo."},{"id":"BG001","title":"Escitalopram","description":"Participants will receive escitalopram."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"177"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"177"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"72.2","spread":"8.2"},{"groupId":"BG001","value":"71.1","spread":"7.4"},{"groupId":"BG002","value":"71.6","spread":"9.9999"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"119"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"58"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"177.0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Response Using Clinical Global Impressions-Improvement Scale (CGI-I)","description":"Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Measured at Weeks 1-12","groups":[{"id":"OG000","title":"Placebo","description":"Participants will receive a placebo."},{"id":"OG001","title":"Escitalopram","description":"Participants will receive escitalopram."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"69"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"69"}]}]}]},{"type":"SECONDARY","title":"Quality of Life","description":"Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).","populationDescription":"Quality of Life scales were collected on all participants randomized to Escitalopram and placebo","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Measured at Week 12","groups":[{"id":"OG000","title":"Escitalopram (1)","description":"Escitalopram\n\nEscitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."},{"id":"OG001","title":"Placebo (2)","description":"Placebo\n\nEscitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"92"}]}],"classes":[{"title":"Week 0 SF-36 Role-Emotional Impairment","categories":[{"measurements":[{"groupId":"OG000","value":"42.19","spread":"36.72"},{"groupId":"OG001","value":"53.42","spread":"38.39"}]}]},{"title":"Week 12 SF-36 Role-Emotional Impairment","categories":[{"measurements":[{"groupId":"OG000","value":"62.50","spread":"37.80"},{"groupId":"OG001","value":"56.16","spread":"38.83"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"3 months","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants will receive a placebo.","seriousNumAffected":0,"seriousNumAtRisk":92,"otherNumAffected":59,"otherNumAtRisk":92},{"id":"EG001","title":"Escitalopram","description":"Participants will receive escitalopram.","seriousNumAffected":0,"seriousNumAtRisk":85,"otherNumAffected":65,"otherNumAtRisk":85}],"otherEvents":[{"term":"Fatigue or somnolence","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":92},{"groupId":"EG001","numAffected":25,"numAtRisk":85}]},{"term":"Gastrointestinal upset","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":92},{"groupId":"EG001","numAffected":22,"numAtRisk":85}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":92},{"groupId":"EG001","numAffected":13,"numAtRisk":85}]},{"term":"Sleep disturbance","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":92},{"groupId":"EG001","numAffected":12,"numAtRisk":85}]},{"term":"Sweating","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":92},{"groupId":"EG001","numAffected":11,"numAtRisk":85}]},{"term":"Urinary symptoms","organSystem":"Renal and urinary disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"increased or decreased frequency and urgency","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":8,"numAtRisk":85}]},{"term":"Increased anxiety or depression","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":92},{"groupId":"EG001","numAffected":7,"numAtRisk":85}]},{"term":"Light-headedness","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":92},{"groupId":"EG001","numAffected":7,"numAtRisk":85}]},{"term":"Tremor","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":92},{"groupId":"EG001","numAffected":7,"numAtRisk":85}]},{"term":"Aches","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":92},{"groupId":"EG001","numAffected":5,"numAtRisk":85}]},{"term":"Rash or pruritus","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":92},{"groupId":"EG001","numAffected":5,"numAtRisk":85}]},{"term":"Sexual","organSystem":"Reproductive system and breast disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":92},{"groupId":"EG001","numAffected":9,"numAtRisk":85}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"LTE60","restrictiveAgreement":true},"pointOfContact":{"title":"Eric Lenze","organization":"Washington University in St. Louis","email":"lenzee@wustl.edu","phone":"314-362-1671"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001008","term":"Anxiety Disorders"},{"id":"D000098647","term":"Generalized Anxiety Disorder"}],"ancestors":[{"id":"D001523","term":"Mental Disorders"}]},"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}