{"protocolSection":{"identificationModule":{"nctId":"NCT00965497","orgStudyIdInfo":{"id":"Pro00003013"},"organization":{"fullName":"University of South Carolina","class":"OTHER"},"briefTitle":"Escitalopram (Lexapro) for Depression MS or ALS","officialTitle":"An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis"},"statusModule":{"statusVerifiedDate":"2011-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-07"},"primaryCompletionDateStruct":{"date":"2010-03","type":"ACTUAL"},"completionDateStruct":{"date":"2010-03","type":"ACTUAL"},"studyFirstSubmitDate":"2009-08-07","studyFirstSubmitQcDate":"2009-08-24","studyFirstPostDateStruct":{"date":"2009-08-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-04-19","resultsFirstSubmitQcDate":"2011-08-04","resultsFirstPostDateStruct":{"date":"2011-09-07","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-04-17","lastUpdatePostDateStruct":{"date":"2019-05-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Meera Narasimhan","investigatorTitle":"Professor","investigatorAffiliation":"University of South Carolina"},"leadSponsor":{"name":"University of South Carolina","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.","detailedDescription":"This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS."},"conditionsModule":{"conditions":["Major Depression","Multiple Sclerosis","Amyotrophic Lateral Sclerosis"],"keywords":["Amyotrophic Lateral Sclerosis","ALS","Multiple Sclerosis","MS","Major Depression","Depression","Major Depressive Disorder","antidepressants","Escitalopram","Lexapro"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":13,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"All patients will receive escitalopram 20 mg daily.","interventionNames":["Drug: escitalopram"]}],"interventions":[{"type":"DRUG","name":"escitalopram","description":"After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton Depression Scale (HAM-D 17).","description":"Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.","timeFrame":"8 weeks"}],"secondaryOutcomes":[{"measure":"McGill Quality of Life Scale (MQOL)","description":"McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).","timeFrame":"8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients between 18 and 70 years of age with documented ALS or MS,\n* DSM-IV episode of non-psychotic Major Depression,\n* ≥14 score on the 17-item HAM-D,\n* Ability to give informed consent.\n\nExclusion Criteria:\n\n* History of psychotic disorders,\n* Psychotic depression,\n* Bipolar depression,\n* Suicide risk,\n* History of substance abuse in the previous 6 months,\n* History of unstable medical disorders,\n* Pregnancy or planning for pregnancy,\n* Severity of ALS or MS that limits participating in the study protocol.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Meera Narasimhan, MD","affiliation":"University of South Carolina School of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of South Carolina School of Medicine","city":"Columbia","state":"South Carolina","zip":"20203","country":"United States","geoPoint":{"lat":34.00071,"lon":-81.03481}}]},"referencesModule":{"references":[{"pmid":"7582177","type":"BACKGROUND","citation":"Cohen SR, Mount BM, Strobel MG, Bui F. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med. 1995 Jul;9(3):207-19. doi: 10.1177/026921639500900306."},{"pmid":"10227631","type":"BACKGROUND","citation":"Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40. doi: 10.1212/wnl.52.7.1434."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients switched from another antidepressant to escitalopram were either cross-titrated to escitalopram over 1 week or went through 3 day washout before starting escitalopram. Subjects with uncontrolled medical conditions (i.e., uncontrolled hypertension)were excluded.","recruitmentDetails":"Recruited through local neurology groups and ALS and MS support groups. No subjects with ALS were recruited.","groups":[{"id":"FG000","title":"Open-label, Single Arm","description":"All patients will receive the intervention"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"14"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Open-label, Single Arm","description":"All patients will receive the intervention"}],"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":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"12"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"14"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton Depression Scale (HAM-D 17).","description":"Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.","populationDescription":"Intention to Treat","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Standard Deviation","unitOfMeasure":"depression severity","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"One-arm study of escitalopram 20 mg daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15","spread":"7"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.01","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"95","ciPctValue":"95","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"McGill Quality of Life Scale (MQOL)","description":"McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Full Range","unitOfMeasure":"quality of life","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Escitalopram","description":"One-arm study of escitalopram 20 mg daily"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5","lowerLimit":"0","upperLimit":"10"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Open-label, Single Arm","description":"All patients will receive the intervention","seriousNumAffected":0,"seriousNumAtRisk":14,"otherNumAffected":5,"otherNumAtRisk":14}],"otherEvents":[{"term":"Nausea vomiting and diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":14}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Meera Narasimhan, MD","organization":"University of South Carolina School of Medicine","email":"shardeman@uscmed.sc.edu","phone":"803-434-1100"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D009103","term":"Multiple Sclerosis"},{"id":"D000690","term":"Amyotrophic Lateral Sclerosis"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D020278","term":"Demyelinating Autoimmune Diseases, CNS"},{"id":"D020274","term":"Autoimmune Diseases of the Nervous System"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D003711","term":"Demyelinating Diseases"},{"id":"D001327","term":"Autoimmune Diseases"},{"id":"D007154","term":"Immune System Diseases"},{"id":"D013118","term":"Spinal Cord Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D016472","term":"Motor Neuron Disease"},{"id":"D019636","term":"Neurodegenerative Diseases"},{"id":"D057177","term":"TDP-43 Proteinopathies"},{"id":"D009468","term":"Neuromuscular Diseases"},{"id":"D057165","term":"Proteostasis Deficiencies"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"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}