[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628893":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":43,"armGroups":39,"interventions":44,"overallOfficials":39,"centralContacts":49,"locations":56,"responsibleParty":120,"collaborators":122,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":39,"enrollmentInfo":135,"targetDuration":39,"studyType":138,"phases":39,"briefSummary":139,"conditions":140,"keywords":39,"overallStatus":71,"whyStopped":39,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":39},[9,13,16,20,23],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8","The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety.","Week 24",{"measure":14,"description":15,"timeFrame":12},"Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8","The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of depression.",{"measure":17,"description":18,"timeFrame":19},"Change from Baseline in HADS Total Score.","The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and\u002For depression.","Baseline to up to Week 24",{"measure":21,"description":22,"timeFrame":12},"Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score","The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.",{"measure":24,"description":25,"timeFrame":19},"Change from Baseline in POEM Total Score.","The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.",[27,31,33,36],{"measure":28,"description":29,"timeFrame":30},"Change from Baseline in Dermatology Life Quality Index (DLQI)\u002FChildren's DLQI total score.","DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to \\[≥\\] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.","Baseline to week 24",{"measure":32,"description":29,"timeFrame":12},"Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI\u002FCDLQI Minimal Clinically Important Difference (MCID)",{"measure":34,"description":35,"timeFrame":19},"Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p)","DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).",{"measure":37,"description":35,"timeFrame":38},"Proportion of Participants with Impacted Professional Life\u002FEducation Status using DermCLCI-p","At Baseline and Week 24.",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":42,"maskingInfo":39},"COHORT","PROSPECTIVE","The study will recruit participants from AD patients who are already receiving dupilumab treatment (Dupixent®) (within 30 days of enrolment) at the start of the study or for whom the investigator has decided to initiate dupilumab therapy (Dupixent®) independently from the study entry. Eligible patients include those who started dupilumab treatment up to 30 days before enrollment and have a baseline Hospital Anxiety and Depression Scale (HADS-A and\u002For HADS-D) score of more than (≥) 8 (±3 days from treatment initiation). Each enrolled participant will undergo a 6-month observational study period",[45],{"type":46,"name":47,"description":48,"armGroupLabels":39,"otherNames":39},"DRUG","Dupilumab","This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.",[50],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[57,69,81,86,96,104,112],{"facility":58,"status":59,"city":60,"state":39,"zip":39,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":39},"Investigational Site: Hamad Medical Corporation","ACTIVE_NOT_RECRUITING","Doha","Qatar","QA",{"type":64,"coordinates":65},"Point",[66,67],51.53096,25.28545,{"lat":67,"lon":66},{"facility":70,"status":71,"city":72,"state":39,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":39},"Investigational Site: Saudi Medical Services (Medical Fakeeh)","RECRUITING","Jeddah","21331","Saudi Arabia","SA",{"type":64,"coordinates":77},[78,79],39.18624,21.49012,{"lat":79,"lon":78},{"facility":82,"status":59,"city":72,"state":39,"zip":39,"country":74,"countryCode":75,"cosmosGeoPoint":83,"geoPoint":85,"contacts":39},"Investigational Site: King Faisal Specialist Hospital",{"type":64,"coordinates":84},[78,79],{"lat":79,"lon":78},{"facility":87,"status":71,"city":88,"state":39,"zip":39,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":39},"Investigational Site: NMC Specialty Hospital LTD","Abu Dhabi","United Arab Emirates","AE",{"type":64,"coordinates":92},[93,94],54.39696,24.45118,{"lat":94,"lon":93},{"facility":97,"status":71,"city":98,"state":39,"zip":39,"country":89,"countryCode":90,"cosmosGeoPoint":99,"geoPoint":103,"contacts":39},"Investigational Site: Dibba Hospital","Fujairah",{"type":64,"coordinates":100},[101,102],56.34141,25.11641,{"lat":102,"lon":101},{"facility":105,"status":71,"city":106,"state":39,"zip":39,"country":89,"countryCode":90,"cosmosGeoPoint":107,"geoPoint":111,"contacts":39},"Investigational Site: Ibrahem Bin Hamad Hospital","Ras al-Khaimah",{"type":64,"coordinates":108},[109,110],55.9432,25.78953,{"lat":110,"lon":109},{"facility":113,"status":59,"city":114,"state":39,"zip":39,"country":89,"countryCode":90,"cosmosGeoPoint":115,"geoPoint":119,"contacts":39},"Investigational Site: Al Qassimi Hospital","Sharjah city",{"type":64,"coordinates":116},[117,118],55.41221,25.3342,{"lat":118,"lon":117},{"type":121,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[123],{"name":124,"class":6},"Regeneron Pharmaceuticals","100628893","the-impact-of-dupilumab-treatment-on-anxiety-and-depression-symptoms-in-patients-with-moderate-to-severe-atopic-dermatitis-100628893",false,"NCT07467564","The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis","The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries","DERMIND-AD","Inclusion Criteria:\n\n* Participants who have moderate to severe AD with signs and symptoms of anxiety and\u002For depression.\n* Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation\n* Participants and\u002For their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.\n\nExclusion Criteria:\n\n* Females who are pregnant, lactating, or planning\u002Fintending to be pregnant in the next 6 months.\n* Participants who are participating in another trial.\n* Participants with active chronic or acute infection requiring systemic treatment.\n* Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.\n* Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.\n* Participants on antidepressants\u002Fanti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants\u002Fanti-anxiety. In addition, those who will use antidepressants\u002Fanti-anxiety medications throughout the study will be excluded from the analysis.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","12 Years",{"count":136,"type":137},184,"ESTIMATED","OBSERVATIONAL","This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.",[141],"Atopic Dermatitis","2026-07-27",{"date":144,"type":145},"2026-07-28","ACTUAL",{"date":147,"type":145},"2026-02-24",{"date":149,"type":137},"2027-05-24",{"name":5,"class":6},7]