[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06605105":3,"trial-entities:NCT06605105":316,"trial-summary:NCT06605105":320},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":67,"locations":70,"central_contacts":309,"overall_officials":310,"references":314,"see_also_links":315},"NCT06605105","CYB003-004","Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)","A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)","ENROLLING_BY_INVITATION","2028-03-15","2026-07","2026-07-13","2025-07-18","Cybin IRL Limited","INDUSTRY",false,"This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.",null,[19],"Major Depressive Disorder",[19,21,22,23,24,25,26,27,28],"MDD","Psilocybin","Psychedelic","CYB003","Depression","CYB003-002","Long-Term Extension","CYB003-003","INTERVENTIONAL","TREATMENT",[32],"PHASE3",{"count":34,"type":35},468,"ESTIMATED",[37],{"type":38,"name":24,"description":39,"armGroupLabels":40},"DRUG","CYB003 is a deuterated psilocin analog",[24],[42],{"measure":43,"description":44,"timeFrame":45},"Montgomery-Asberg Depression Rating Scale (MADRS)","The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity. The scale consists of ten items rated on a scale from 0 to 6, resulting in a total score ranging from 0 (normal \u002F symptom absent) to 60 (severe depression).","Baseline, Day 28, Day 56, Day 84, Day 112, Day 140, Day 168, Day 196, Day 244, Day 252, Day 280, Day 301; additional assessments at Day -15, Day -1, Day 2, Day 10, Day 17, Day 21, Day 23, Day 31, Day 42 if non-response or relapse criteria met",[],"ALL","18 Years","85 Years",{"inclusion":51,"exclusion":58,"raw_text":66},[52,53,54,55,56,57],"Has successfully completed either CYB003-002 APPROACH or CYB003-003 EMBRACE and received both dose administrations of trial medication","Has continued the same antidepressant medication at the stable dose\u002Fday throughout CYB003-002 APPROACH or CYB003-003 EMBRACE","Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form","Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant's final dose of IP","Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP","Female participants must have a negative pregnancy test at Baseline (the end of trial \\[EOT\\] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day",[59,60,61,62,63,64,65],"newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial","Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Baseline OR has experienced an adverse event (AE) of suicide ideation\u002Fattempt or self-harm in CYB003-002 APPROACH OR has had a \\>1 point change in item 1 or 2 of the C-SSRS from Screening in CYB003-002 APPROACH","Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial","Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND","Sensitivity or suspected sensitivity to CYB003 noted in the APPROACH or EMBRACE trial","Positive urine test for drugs of abuse, or alcohol breath test prior to dosing.","Unwilling to consent to audio and video recording of psychological support and dosing sessions","Inclusion Criteria:\n\n* Has successfully completed either CYB003-002 APPROACH or CYB003-003 EMBRACE and received both dose administrations of trial medication\n* Has continued the same antidepressant medication at the stable dose\u002Fday throughout CYB003-002 APPROACH or CYB003-003 EMBRACE\n* Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form\n* Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant's final dose of IP\n* Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP\n* Female participants must have a negative pregnancy test at Baseline (the end of trial \\[EOT\\] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day\n\nExclusion Criteria:\n\n* newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial\n* Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Baseline OR has experienced an adverse event (AE) of suicide ideation\u002Fattempt or self-harm in CYB003-002 APPROACH OR has had a \\>1 point change in item 1 or 2 of the C-SSRS from Screening in CYB003-002 APPROACH\n* Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial\n* Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND\n* Sensitivity or suspected sensitivity to CYB003 noted in the APPROACH or EMBRACE trial\n* Positive urine test for drugs of abuse, or alcohol breath test prior to dosing.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions",[68,69],"ADULT","OLDER_ADULT",[71,80,88,95,103,110,118,125,132,138,145,149,157,161,168,176,183,186,194,202,209,217,224,231,239,247,255,262,270,279,287,295,302],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"Combined Research Orlando","Phoenix","Arizona","85022","United States",{"lat":78,"lon":79},33.44838,-112.07404,{"facility":81,"city":82,"state":83,"zip":84,"country":76,"geoPoint":85},"Open Mind Collective \u002F UCSF Medical Center - Mount Zion","San Francisco","California","94114",{"lat":86,"lon":87},37.77493,-122.41942,{"facility":89,"city":90,"state":83,"zip":91,"country":76,"geoPoint":92},"Inland Psychiatric Medical Group Inc (IPMG Research)","San Juan Capistrano","92675",{"lat":93,"lon":94},33.50169,-117.66255,{"facility":96,"city":97,"state":98,"zip":99,"country":76,"geoPoint":100},"Mountain View Clinical Research","Denver","Colorado","80209",{"lat":101,"lon":102},39.73915,-104.9847,{"facility":104,"city":105,"state":98,"zip":106,"country":76,"geoPoint":107},"Starlight Clinical Research","Evergreen","80439",{"lat":108,"lon":109},39.63332,-105.31721,{"facility":111,"city":112,"state":113,"zip":114,"country":76,"geoPoint":115},"Research Centers of America","Hollywood","Florida","33024",{"lat":116,"lon":117},26.0112,-80.14949,{"facility":119,"city":120,"state":113,"zip":121,"country":76,"geoPoint":122},"K2 Medical Research","Lady Lake","32159",{"lat":123,"lon":124},28.91749,-81.92286,{"facility":126,"city":127,"state":113,"zip":128,"country":76,"geoPoint":129},"Segal Trials Center for Psychedelic Research","Lauderhill","33319",{"lat":130,"lon":131},26.14036,-80.21338,{"facility":119,"city":133,"state":113,"zip":134,"country":76,"geoPoint":135},"Maitland","32751",{"lat":136,"lon":137},28.62778,-81.36312,{"facility":139,"city":140,"state":113,"zip":141,"country":76,"geoPoint":142},"Clinical Neuroscience Solutions, Inc","Orlando","32801",{"lat":143,"lon":144},28.53834,-81.37924,{"facility":146,"city":140,"state":113,"zip":147,"country":76,"geoPoint":148},"Charter Research","32803",{"lat":143,"lon":144},{"facility":150,"city":151,"state":152,"zip":153,"country":76,"geoPoint":154},"Cenexel iResearcvh Atlanta, LLC","Atlanta","Georgia","30030",{"lat":155,"lon":156},33.749,-84.38798,{"facility":158,"city":151,"state":152,"zip":159,"country":76,"geoPoint":160},"Atlanta Center For Medical Research","30331",{"lat":155,"lon":156},{"facility":162,"city":163,"state":152,"zip":164,"country":76,"geoPoint":165},"CenExel iResearch","Savannah","31405",{"lat":166,"lon":167},32.08354,-81.09983,{"facility":169,"city":170,"state":171,"zip":172,"country":76,"geoPoint":173},"Uptown Research Institute","Chicago","Illinois","60640",{"lat":174,"lon":175},41.85003,-87.65005,{"facility":177,"city":178,"state":171,"zip":179,"country":76,"geoPoint":180},"Psychiatric Medicine Associates, LLC","Skokie","60076",{"lat":181,"lon":182},42.03336,-87.73339,{"facility":184,"city":178,"state":171,"zip":179,"country":76,"geoPoint":185},"Psychiatric Medicine Associates",{"lat":181,"lon":182},{"facility":187,"city":188,"state":189,"zip":190,"country":76,"geoPoint":191},"Sunstone Medical, PC","Rockville","Maryland","20850",{"lat":192,"lon":193},39.084,-77.15276,{"facility":195,"city":196,"state":197,"zip":198,"country":76,"geoPoint":199},"Adams Clinical Boston","Boston","Massachusetts","02116",{"lat":200,"lon":201},42.35843,-71.05977,{"facility":203,"city":204,"state":197,"zip":205,"country":76,"geoPoint":206},"Adams Clinical","Watertown","02472",{"lat":207,"lon":208},42.37093,-71.18283,{"facility":210,"city":211,"state":212,"zip":213,"country":76,"geoPoint":214},"Redbird Research","Las Vegas","Nevada","89119",{"lat":215,"lon":216},36.17497,-115.13722,{"facility":218,"city":219,"state":219,"zip":220,"country":76,"geoPoint":221},"Adams Clinical Harlem","New York","10029",{"lat":222,"lon":223},40.71427,-74.00597,{"facility":225,"city":226,"state":219,"zip":227,"country":76,"geoPoint":228},"Adams Clinical Bronx","The Bronx","10461",{"lat":229,"lon":230},40.84985,-73.86641,{"facility":232,"city":233,"state":234,"zip":235,"country":76,"geoPoint":236},"Neurobehavioral Clinical Research","Canton","Ohio","44720",{"lat":237,"lon":238},40.79895,-81.37845,{"facility":240,"city":241,"state":242,"zip":243,"country":76,"geoPoint":244},"Clinical Neuroscience Solutions, CNS Healthcare","Memphis","Tennessee","38119",{"lat":245,"lon":246},35.14953,-90.04898,{"facility":248,"city":249,"state":250,"zip":251,"country":76,"geoPoint":252},"InSite Clinical Research, LLC","DeSoto","Texas","75115",{"lat":253,"lon":254},32.58986,-96.85695,{"facility":256,"city":257,"state":250,"zip":258,"country":76,"geoPoint":259},"Zillan Clinical Research","Houston","77082",{"lat":260,"lon":261},29.76328,-95.36327,{"facility":263,"city":264,"state":265,"zip":266,"country":76,"geoPoint":267},"Cedar Clinical Research","Draper","Utah","84020",{"lat":268,"lon":269},40.52467,-111.86382,{"facility":271,"city":272,"state":273,"zip":274,"country":275,"geoPoint":276},"Sydney Local Health District","Camperdown","New South Wales","2050","Australia",{"lat":277,"lon":278},-33.88965,151.17642,{"facility":280,"city":281,"state":282,"zip":283,"country":275,"geoPoint":284},"Thompson Brain & Mind Healthcare","Maroochydore","Queensland","4558",{"lat":285,"lon":286},-26.66008,153.09953,{"facility":288,"city":289,"state":290,"zip":291,"country":275,"geoPoint":292},"Neurocentrix Research","Carlton","Victoria","3053",{"lat":293,"lon":294},-37.8,144.96667,{"facility":296,"city":297,"state":290,"zip":298,"country":275,"geoPoint":299},"Ramsay Clinic","Melbourne","3004",{"lat":300,"lon":301},-37.814,144.96332,{"facility":303,"city":304,"state":290,"zip":305,"country":275,"geoPoint":306},"Monash University - Notting Hill","Notting Hill","3168",{"lat":307,"lon":308},-37.905,145.1427,[],[311],{"name":312,"affiliation":13,"role":313},"Clinical Development","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":317,"biomarkers":319},[318],"Unipolar Depression",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]