{"protocolSection":{"identificationModule":{"nctId":"NCT00887679","orgStudyIdInfo":{"id":"Pro00011288"},"secondaryIdInfos":[{"id":"LXP-MD-0148"}],"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS","officialTitle":"Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder, Adherence to Antiretroviral Therapy,Cognition, and Immune Status Among Patients With HIV and AIDS: A 6-week Open-label, Prospective, Pilot Trial."},"statusModule":{"statusVerifiedDate":"2014-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-05"},"primaryCompletionDateStruct":{"date":"2009-09","type":"ACTUAL"},"completionDateStruct":{"date":"2010-09","type":"ACTUAL"},"studyFirstSubmitDate":"2009-04-23","studyFirstSubmitQcDate":"2009-04-23","studyFirstPostDateStruct":{"date":"2009-04-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-11-19","resultsFirstSubmitQcDate":"2014-03-07","resultsFirstPostDateStruct":{"date":"2014-03-10","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-10-23","lastUpdatePostDateStruct":{"date":"2014-10-31","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Duke University","class":"OTHER"},"collaborators":[{"name":"Forest Laboratories","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder.","detailedDescription":"Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders; Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the most frequent. Non-adherence to anti-retroviral medications is commonly seen in patients with HIV with GAD.The role of specific selective serotonin reuptake (SSRIs) in the treatment of HIV-patients with GAD is unclear. Escitalopram has been used in the treatment of GAD in the general population. It has been shown to be safe in HIV-patients with a tolerable side-effect profile. However, whether it can improve GAD in HIV-infected patients has not yet been investigated."},"conditionsModule":{"conditions":["Anxiety Disorders","HIV Infections"],"keywords":["Escitalopram","Anxiety Disorder","HIV and AIDS","treatment experienced"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Open label, rater-blinded, prospective, 6-week trial of escitalopram.Subjects received escitalopram 10-20mg. Escitalopram was started at 10mg per day and augmented weekly in 10mg per day increments, the maximum dose being 20mg per day.","interventionNames":["Drug: Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.","armGroupLabels":["Escitalopram"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)","description":"The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.","timeFrame":"baseline and 7 weeks"},{"measure":"Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory","description":"Scoring\n\nThe BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows:\n\n(0) I do not feel sad.\n\n1. I feel sad.\n2. I am sad all the time and I can't snap out of it.\n3. I am so sad or unhappy that I can't stand it.\n\nA value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:\\[6\\] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.\n\nHigher total scores indicate more severe depressive symptoms.","timeFrame":"baseline and 7 weeks"}],"secondaryOutcomes":[{"measure":"Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)","description":"Scale for scoring:\n\nClinical Global Impression(CGI-S)\n\n1. = Normal, no symptoms\n2. = Borderline ill\n3. = Mildly ill\n4. = Moderately ill\n5. = Markedly ill\n6. = Severely ill\n7. = Most extremely ill\n\nClinical Global Impression(CGI-I)-improvement since treatment\n\n1. very much improved\n2. much improved\n3. minimally improved\n4. no change from baseline\n5. minimally worse\n6. much worse\n7. very much worse","timeFrame":"baseline and 7 weeks"},{"measure":"Change From Randomization to End of Treatment for Trail Making Tet (TMT)","description":"Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment.\n\nAverage =29 seconds, Deficient \\> 78 seconds","timeFrame":"baseline to 7 weeks"},{"measure":"Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)","description":"Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30.","timeFrame":"baseline and 7 weeks"},{"measure":"Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)","description":"Scoring:\n\nParticipants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant.","timeFrame":"baseline and 7 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* age 18 to 65 years,\n* DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for Generalized Anxiety Disorder\n* confirmed stable HIV disease and attending a HIV treatment program\n* stable dose of highly active anti-retroviral therapy for a minimum of 4 weeks\n* ability to give informed consent\n\nExclusion Criteria:\n\n* bipolar disorders, any psychotic disorder\n* current major depression\n* substance dependence (except nicotine dependence) in the previous 3 months\n* currently suicidal or high suicide risk, serious or unstable medical disorders (e.g. uncontrolled hypertension or diabetes)\n* any hospitalization for HIV-related illness in the previous 3 months\n* any active CNS (central nervous system) CNS opportunistic infection or CNS malignancies related to HIV\n* current active treatment for opportunistic infections related to HIV\n* any psychotropic drug treatment in the previous 2 weeks before screening\n* history of hypersensitivity to escitalopram and/or citalopram\n* admission BDI 23\n* seizure disorder, traumatic brain injury\n* pregnant, nursing mother or planning to get pregnant.\n* Concomitant mediations: At least 2-week washout of antidepressant (4 weeks for fluoxetine) or antipsychotic or anti-anxiety medications.\n* In the opinion of the investigator the clinical condition precludes participation in the trial.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ashwin A Patkar, MD","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":[{"pmid":"16639343","type":"BACKGROUND","citation":"Pence BW, Miller WC, Whetten K, Eron JJ, Gaynes BN. Prevalence of DSM-IV-defined mood, anxiety, and substance use disorders in an HIV clinic in the Southeastern United States. J Acquir Immune Defic Syndr. 2006 Jul;42(3):298-306. doi: 10.1097/01.qai.0000219773.82055.aa."},{"pmid":"14534388","type":"BACKGROUND","citation":"Tucker JS, Kanouse DE, Miu A, Koegel P, Sullivan G. HIV risk behaviors and their correlates among HIV-positive adults with serious mental illness. AIDS Behav. 2003 Mar;7(1):29-40. doi: 10.1023/a:1022557222690."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Anxiety disorders in HIV-infected patients from the general population","groups":[{"id":"FG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"20 subjects completed the study.","numSubjects":"20"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS."}],"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":"43.6","spread":"8.12"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"20"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"30"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)","description":"The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.","populationDescription":"3 patients dropped out, 4 patients did not met the criteria, and 3 patients did not show up.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on an anxiety scale","timeFrame":"baseline and 7 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Subjects received escitalopram 10-20mg. Escitalopram was started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.23","spread":"2.57"}]}]}]},{"type":"PRIMARY","title":"Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory","description":"Scoring\n\nThe BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows:\n\n(0) I do not feel sad.\n\n1. I feel sad.\n2. I am sad all the time and I can't snap out of it.\n3. I am so sad or unhappy that I can't stand it.\n\nA value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:\\[6\\] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.\n\nHigher total scores indicate more severe depressive symptoms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"baseline and 7 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.8","spread":"7.89"}]}]}]},{"type":"SECONDARY","title":"Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)","description":"Scale for scoring:\n\nClinical Global Impression(CGI-S)\n\n1. = Normal, no symptoms\n2. = Borderline ill\n3. = Mildly ill\n4. = Moderately ill\n5. = Markedly ill\n6. = Severely ill\n7. = Most extremely ill\n\nClinical Global Impression(CGI-I)-improvement since treatment\n\n1. very much improved\n2. much improved\n3. minimally improved\n4. no change from baseline\n5. minimally worse\n6. much worse\n7. very much worse","populationDescription":"3 patients dropped out, 4 patients did not meet criteria, and 3 patients did not show up.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"baseline and 7 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"title":"Clinical Global Impression (CGI-I)","categories":[{"measurements":[{"groupId":"OG000","value":"1","spread":"0.0"}]}]},{"title":"Clinical Global Impression (CGI-S)","categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change From Randomization to End of Treatment for Trail Making Tet (TMT)","description":"Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment.\n\nAverage =29 seconds, Deficient \\> 78 seconds","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"seconds","timeFrame":"baseline to 7 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29.2","spread":"11.23"}]}]}]},{"type":"SECONDARY","title":"Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)","description":"Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"baseline and 7 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"}]}]}]},{"type":"SECONDARY","title":"Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)","description":"Scoring:\n\nParticipants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"baseline and 7 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"3","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.","seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":21,"otherNumAtRisk":30}],"otherEvents":[{"term":"nause","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":30}]},{"term":"dizziness","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30}]},{"term":"diarrhea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}]},{"term":"dry mouth","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30}]},{"term":"headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}]},{"term":"constipation","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Ashwin A Patkar Associate Professor","organization":"Duke University Medical Center","email":"ashwin.patkar@duke.edu","phone":"919-668-3626"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001008","term":"Anxiety Disorders"},{"id":"D015658","term":"HIV Infections"},{"id":"D000163","term":"Acquired Immunodeficiency Syndrome"}],"ancestors":[{"id":"D001523","term":"Mental Disorders"},{"id":"D000086982","term":"Blood-Borne Infections"},{"id":"D003141","term":"Communicable Diseases"},{"id":"D007239","term":"Infections"},{"id":"D015229","term":"Sexually Transmitted Diseases, Viral"},{"id":"D012749","term":"Sexually Transmitted Diseases"},{"id":"D016180","term":"Lentivirus Infections"},{"id":"D012192","term":"Retroviridae Infections"},{"id":"D012327","term":"RNA Virus Infections"},{"id":"D014777","term":"Virus Diseases"},{"id":"D000091662","term":"Genital Diseases"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D007153","term":"Immunologic Deficiency Syndromes"},{"id":"D007154","term":"Immune System Diseases"},{"id":"D012897","term":"Slow Virus Diseases"}]},"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}