[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440593":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":260,"collaborators":263,"id":283,"slug":284,"hasResults":285,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":290,"sex":291,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":51,"studyType":297,"phases":298,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":59,"whyStopped":51,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},{"fullName":5,"class":6},"Nova Scotia Health Authority","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Allocation by Predictive Biomarker Algorithm; Escitalopram + Brexpiprazole","ACTIVE_COMPARATOR","Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted as non-responders to escitalopram monotherapy will receive open-label escitalopram (10-20 mg\u002Fd) and blinded brexpiprazole (0.5-2 mg\u002Fd) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.",[13,14],"Drug: Escitalopram","Drug: Brexpiprazole",{"label":16,"type":17,"description":18,"interventionNames":19},"Allocation by Predictive Biomarker Algorithm; Placebo","PLACEBO_COMPARATOR","Patients are randomly assigned to the Allocation by Predictive Biomarker Algorithm group. Based on the outcome result from the personalized predictive biomarker algorithm, patients predicted to respond to escitalopram monotherapy will receive open-label escitalopram (10-20 mg\u002Fd) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.",[13],{"label":21,"type":10,"description":22,"interventionNames":23},"Random Allocation; Escitalopram + Brexpiprazole","Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg\u002Fd) and blinded brexpiprazole (0.5-2 mg\u002Fd) for the first 8 weeks of the study. For the final 4 weeks of the study, patients will continue to receive both medications but the brexpiprazole will no longer be blinded.",[13,14],{"label":25,"type":17,"description":26,"interventionNames":27},"Random Allocation; Placebo","Patients are randomly assigned to the Random Allocation group and then randomly assigned to receive open-label escitalopram (10-20 mg\u002Fd) and blinded placebo for the first 8 weeks of the study. For the final 4 weeks of the study, responders will continue to receive open-label escitalopram without the placebo and non-responders will receive a combination of open-label escitalopram and open-label brexpiprazole.",[13],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Escitalopram","All patients will receive open-label escitalopram (10-20 mg\u002Fd) for the entire study duration (12 weeks).",[9,16,21,25],[35],"Cipralex",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Brexpiprazole","Depending on the initial randomization process, patients will either receive blinded brexpiprazole (0.5-2 mg\u002Fd) for the entire study duration (12 weeks) or for the last 4 weeks of the study if they received the placebo during the first 8 weeks of the study and were non-responders.",[9,21],[41],"Rexulti",[43],{"name":44,"affiliation":5,"role":45},"Rudolf Uher, MD, PhD","PRINCIPAL_INVESTIGATOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Jessica B Toombs, MSc","CONTACT","9024735313",null,"Jessica.Toombs@NSHealth.ca",{"name":54,"role":49,"phone":50,"phoneExt":51,"email":55},"Nicole M Stinson, BSc","Nicole.Stinson@NSHealth.ca",[57,82,103,119,141,162,183,204,222,243],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"University of Calgary","RECRUITING","Calgary","Alberta","T2N 2T9","Canada","CA",{"type":66,"coordinates":67},"Point",[68,69],-114.08529,51.05011,{"lat":69,"lon":68},[72,76,80],{"name":73,"role":49,"phone":74,"phoneExt":51,"email":75},"Maddie Kelly","403-210-7445","Madison.Kelly@ucalgary.ca",{"name":77,"role":49,"phone":78,"phoneExt":51,"email":79},"Alex Du","403-220-6533","mi.du@ucalgary.ca",{"name":81,"role":45,"phone":51,"phoneExt":51,"email":51},"Valerie H Taylor, MD, PhD",{"facility":83,"status":59,"city":84,"state":85,"zip":86,"country":63,"countryCode":64,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University of British Columbia","Vancouver","British Columbia","V6T2A1",{"type":66,"coordinates":88},[89,90],-123.11934,49.24966,{"lat":90,"lon":89},[93,97,101],{"name":94,"role":49,"phone":95,"phoneExt":51,"email":96},"Sara Lee","604-822-0332","Sara.Lee@ubc.ca",{"name":98,"role":49,"phone":99,"phoneExt":51,"email":100},"Jennifer Tong","604-822-8012","Jennifer.Tong@ubc.ca",{"name":102,"role":45,"phone":51,"phoneExt":51,"email":51},"Raymond W Lam, MD",{"facility":5,"status":59,"city":104,"state":105,"zip":106,"country":63,"countryCode":64,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Halifax","Nova Scotia","B3H 2E2",{"type":66,"coordinates":108},[109,110],-63.57688,44.64269,{"lat":110,"lon":109},[113,116,118],{"name":114,"role":49,"phone":115,"phoneExt":51,"email":52},"Jessica Toombs, MSc","902-473-5313",{"name":117,"role":49,"phone":115,"phoneExt":51,"email":55},"Nicole Stinson, BSc",{"name":44,"role":45,"phone":51,"phoneExt":51,"email":51},{"facility":120,"status":59,"city":121,"state":122,"zip":123,"country":63,"countryCode":64,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"McMaster University","Hamilton","Ontario","L8P3B6",{"type":66,"coordinates":125},[126,127],-79.84963,43.25011,{"lat":127,"lon":126},[130,135,139],{"name":131,"role":49,"phone":132,"phoneExt":133,"email":134},"Elizabeth Hewitson","905-522-1155","39178","ehewitso@stjoes.ca",{"name":136,"role":49,"phone":132,"phoneExt":137,"email":138},"Saba Khoshroo","36462","skhoshro@stjoes.ca",{"name":140,"role":45,"phone":51,"phoneExt":51,"email":51},"Benicio N Frey, MD, PhD",{"facility":142,"status":59,"city":143,"state":122,"zip":144,"country":63,"countryCode":64,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Queen's University","Kingston","K7L4X3",{"type":66,"coordinates":146},[147,148],-76.48098,44.22976,{"lat":148,"lon":147},[151,156,160],{"name":152,"role":49,"phone":153,"phoneExt":154,"email":155},"Caroline Côté","613-544-4900","52212","c.cote@queensu.ca",{"name":157,"role":49,"phone":153,"phoneExt":158,"email":159},"Rida Khan","53354","khanr@providencecare.ca",{"name":161,"role":45,"phone":51,"phoneExt":51,"email":51},"Roumen Milev, MD, PhD",{"facility":163,"status":59,"city":164,"state":122,"zip":165,"country":63,"countryCode":64,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"The Royal Ottawa Mental Health Centre","Ottawa","K1Z 7K4",{"type":66,"coordinates":167},[168,169],-75.69812,45.41117,{"lat":169,"lon":168},[172,177,181],{"name":173,"role":49,"phone":174,"phoneExt":175,"email":176},"Dikshpreet Kaur","613-722-6521","6856","Dikshpreet.Kaur@theroyal.ca",{"name":178,"role":49,"phone":174,"phoneExt":179,"email":180},"Yamini Singh","6405","Yamini.Singh@theroyal.ca",{"name":182,"role":45,"phone":51,"phoneExt":51,"email":51},"Pierre Blier, MD, PhD",{"facility":184,"status":59,"city":185,"state":122,"zip":186,"country":63,"countryCode":64,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"University Health Network","Toronto","M5T2S8",{"type":66,"coordinates":188},[189,190],-79.39864,43.70643,{"lat":190,"lon":189},[193,198,202],{"name":194,"role":49,"phone":195,"phoneExt":196,"email":197},"Yudi Kang","416-603-5800","6094","Yudi.Kang@uhn.ca",{"name":199,"role":49,"phone":195,"phoneExt":200,"email":201},"Franca Placenza, PhD","8839","Franca.Placenza@uhn.ca",{"name":203,"role":45,"phone":51,"phoneExt":51,"email":51},"Joshua Rosenblat, MD, MSc",{"facility":205,"status":59,"city":185,"state":122,"zip":206,"country":63,"countryCode":64,"cosmosGeoPoint":207,"geoPoint":209,"contacts":210},"Centre for Addiction and Mental Health","M6J1H4",{"type":66,"coordinates":208},[189,190],{"lat":190,"lon":189},[211,216,220],{"name":212,"role":49,"phone":213,"phoneExt":214,"email":215},"Victoria Herbert","416-535-8501","30186","Victoria.Herbert@camh.ca",{"name":217,"role":49,"phone":213,"phoneExt":218,"email":219},"Dima Alkaed","39019","Dima.Alkaed@camh.ca",{"name":221,"role":45,"phone":51,"phoneExt":51,"email":51},"Stefan J Kloiber, MD, PhD",{"facility":223,"status":59,"city":224,"state":122,"zip":225,"country":63,"countryCode":64,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Ontario Shores Centre for Mental Health Sciences","Whitby","L1N 0H7",{"type":66,"coordinates":227},[228,229],-78.93287,43.88342,{"lat":229,"lon":228},[232,237,241],{"name":233,"role":49,"phone":234,"phoneExt":235,"email":236},"Houra Parsinejad","905-430-4055","6134","parsinejadh@ontarioshores.ca",{"name":238,"role":49,"phone":234,"phoneExt":239,"email":240},"Emily Vernum","6081","vernume@ontarioshores.ca",{"name":242,"role":45,"phone":51,"phoneExt":51,"email":51},"Daniel Müeller, MD, PhD",{"facility":244,"status":59,"city":245,"state":246,"zip":247,"country":63,"countryCode":64,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"University of Saskatchewan","Saskatoon","Saskatchewan","S7N 0W8",{"type":66,"coordinates":249},[250,251],-106.66892,52.13238,{"lat":251,"lon":250},[254,258],{"name":255,"role":49,"phone":256,"phoneExt":51,"email":257},"Quentin Greba","306-371-7987","qmg131@usask.ca",{"name":259,"role":45,"phone":51,"phoneExt":51,"email":51},"AG (Adekunle Garba) Ahmed, MBBS, MSc",{"type":45,"investigatorFullName":261,"investigatorTitle":262,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Rudolf Uher","Staff Psychiatrist, Independent Investigator, Professor",[264,266,267,268,269,271,272,273,275,277,279,281,282],{"name":265,"class":6},"Unity Health Toronto",{"name":205,"class":6},{"name":120,"class":6},{"name":142,"class":6},{"name":270,"class":6},"University of Ottawa",{"name":83,"class":6},{"name":58,"class":6},{"name":274,"class":6},"McGill University",{"name":276,"class":6},"Dalhousie University",{"name":278,"class":6},"University of Michigan",{"name":280,"class":6},"Simon Fraser University",{"name":223,"class":6},{"name":244,"class":6},"100440593","phase-4-optimized-predictive-treatment-in-medications-for-unipolar-major-depression-optimum-d-100440593",false,"NCT05017311","Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)","CAN-BIND-17","Patients\n\nInclusion Criteria:\n\n* Outpatients 18 to 65 years of age.\n* Meet DSM-5 criteria for MDE in MDD as determined by SCID-5.\n* Free of psychotropic medications for at least 5 half-lives (e.g. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1 (exceptions: stable use of hypnotics; stable use of stimulants for attention-deficit\u002Fhyperactive disorder).\n* MADRS score ≥ 24.\n* Fluency in English, sufficient to complete the interviews and self-report questionnaires.\n\nExclusion Criteria:\n\n* Any diagnosis, other than MDD, that is considered the primary diagnosis.\n* Bipolar I or Bipolar-II diagnosis.\n* Presence of a significant Axis II diagnosis (borderline, antisocial).\n* High suicidal risk, defined by clinician judgment.\n* Substance dependence\u002Fabuse in the past 6 months.\n* Presence of significant neurological disorders, head trauma, or other unstable medical conditions.\n* Pregnant or breastfeeding.\n* Failure of 4 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form).\n* Started psychological treatment within the past 3 months with the intent of continuing treatment.\n* Patients who have previously failed escitalopram or showed intolerance to escitalopram or brexpiprazole, and patients at risk for hypomanic switch (i.e. with a history of antidepressant induced hypomania).\n\nHealthy Comparison (HC) Participants\n\nInclusion Criteria:\n\n* 18 to 65 years of age.\n* No history of psychiatric disorders (as determined by SCID-5) or significant physical conditions (e.g. arthritis, fibromyalgia).\n* Fluency in English, sufficient to complete the interviews and self-report questionnaires.",true,"ALL","18 Years","65 Years",{"count":295,"type":296},400,"ESTIMATED","INTERVENTIONAL",[299],"PHASE4","This is a study that will test a predictive biomarker algorithm based on results from a previous study. The goal of this study is to integrate clinical, imaging, EEG, and molecular data across 8 sites to predict treatment outcome for patients experiencing a major depressive episode (MDE).",[302],"Major Depressive Disorder",[304,305,306,307,308,309,310,311,312],"major depression","major depressive disorder","MDD","escitalopram","brexpiprazole","neuroimaging","genomics","proteomics","metabolomics","2026-06-09",{"date":315,"type":316},"2026-06-11","ACTUAL",{"date":318,"type":316},"2023-01-20",{"date":320,"type":296},"2029-04-30",{"name":5,"class":6},10]