[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555446":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":48,"centralContacts":52,"locations":58,"responsibleParty":74,"collaborators":78,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":47,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":60,"whyStopped":47,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Vail Health Behavioral Health","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Psilocybin + taVNS","EXPERIMENTAL","Participants in this arm will receive a single 25 mg dose of psilocybin, followed by twice-daily sessions of taVNS for 7 consecutive days. Each taVNS session will be paired with music and prompts related to the participant's psilocybin experience.",[13,14],"Drug: Psilocybin","Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)",{"label":16,"type":17,"description":18,"interventionNames":19},"Group 2: Psilocybin + Sham taVNS","SHAM_COMPARATOR","Participants in this arm will receive a single 25 mg dose of psilocybin, followed by twice-daily sham taVNS sessions for 7 consecutive days. Each sham session will be paired with music and prompts related to the participant's psilocybin experience.",[13,20],"Device: Sham taVNS",{"label":22,"type":23,"description":24,"interventionNames":25},"Group 3: Psilocybin + No taVNS","ACTIVE_COMPARATOR","Participants in this arm will receive a single 25 mg dose of psilocybin, followed by no additional intervention. They will receive the standard psychological support related to their psilocybin experience, but no taVNS or sham device will be used.",[13],[27,36,43],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Psilocybin","The psilocybin used in this study is synthesized under Good Manufacturing Practice (GMP) guidelines and is provided in a capsule containing 25 mg of synthetic psilocybin.",[9,16,22],[33,34,35],"Psilocybine","Psilocibin","Usona Institute Psilocybin",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","Participants will be provided with a taVNS device and trained on its use. The device delivers gentle stimulation to the left ear.",[9],[42],"taVNS",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Sham taVNS","Participants will be provided with a taVNS device and trained on its use. The device delivers gentle stimulation to the left ear. In the sham condition, the device will simulate the sensations of active taVNS without delivering therapeutic stimulation.",[16],null,[49],{"name":50,"affiliation":5,"role":51},"Charles Raison, MD","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":47,"email":57},"Program Manager","CONTACT","(970) 855-7374","bhic@vailhealth.org",[59],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Edwards","Colorado","81632","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-106.5942,39.64499,{"lat":70,"lon":69},[73],{"name":54,"role":55,"phone":56,"phoneExt":47,"email":57},{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"SPONSOR_INVESTIGATOR","Charles Raison","Vail Health Behavioral Health Innovation Center Director",[79,81,83,85],{"name":80,"class":6},"Usona Institute",{"name":82,"class":6},"Tiny Blue Dot Foundation",{"name":84,"class":6},"Steadman Philippon Research Institute",{"name":86,"class":6},"Emory University","100555446","investigation-to-understand-and-optimize-psilocybin-100555446",false,"NCT06512194","Investigation to Understand and Optimize Psilocybin","An Investigation of Strategies to Understand and Optimize the Antidepressant Effects of Psilocybin (The OPTIMIZE Study)","OPTIMIZE","Inclusion Criteria:\n\nCurrent diagnosis of Major Depressive Disorder (MDD), with a depressive episode lasting ≥ 60 consecutive days at the time of screening, as confirmed by structured clinical interview\n\nMedically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject.\n\nExclusion Criteria:\n\nHistory or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results (e.g., bipolar disorder, psychosis, seizure disorder, or cardiovascular disease).\n\nKnown family history of a psychotic disorder (e.g., schizophrenia or schizoaffective disorder) in a first-degree relative (biological parent, full sibling, or child).\n\nCurrent active suicidal ideation with a specific plan within the prior 2 weeks, as assessed via clinical interview and validated instrument (e.g., C-SSRS).\n\nSuicide attempt within the prior 6 months, regardless of intent or lethality.\n\nCurrent diagnosis of a substance use disorder\n\nAbnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician).\n\nUnwilling or unable to discontinue prescription psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics, lithium, anticonvulsants, or mood stabilizers) for the duration of study participation, including any necessary washout period as determined by the investigator.\n\nAny condition, finding, or behavior (including suspected deception or noncompliance) that, in the opinion of the investigator, renders the participant unsuitable for the study or likely to interfere with the integrity of the data or safety of the subject.","ALL","18 Years","70 Years",{"count":99,"type":100},141,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.",[106],"Depression",[108,109,110,111,112,113,114,115,116,117],"depression","psilocybin","psychedelics","transcutaneous auricular vagus nerve stimulation","depressive symptoms","well-being","adverse events","ecological momentary assessment","electronically activated recorder","dynamical complexity assessment","2026-08-05",{"date":120,"type":121},"2026-08-10","ACTUAL",{"date":123,"type":121},"2025-05-13",{"date":125,"type":100},"2029-05",{"name":76,"class":6},1]