[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636169":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":43,"centralContacts":43,"locations":44,"responsibleParty":136,"collaborators":139,"id":142,"slug":43,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":143,"sex":149,"minAge":150,"maxAge":43,"enrollmentInfo":151,"targetDuration":43,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":164,"overallStatus":98,"whyStopped":43,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Universidade Federal do Rio Grande do Norte","OTHER",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"High-Dose DMT → Remitters (No Re-dosing)","EXPERIMENTAL","Participants randomized to the high-dose DMT group (15 mg followed by 60 mg on Day 0) who achieve remission at Day 7 (MADRS ≤10) receive no further dosing and enter long-term follow-up.",[13],"Drug: N,N-Dimethyltryptamine (15 mg + 60 mg)",{"label":15,"type":10,"description":16,"interventionNames":17},"High-Dose DMT → Non-Remitters (Open-Label Re-dosing)","Participants randomized to the high-dose DMT group (15 mg followed by 60 mg on Day 0) who do not achieve remission at Day 7 (MADRS \\>10) receive an additional open-label high-dose session (15 mg followed by 60 mg) on Day 14 (±3 days), followed by long-term follow-up.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Low-Dose DMT → Remitters (No Re-dosing)","ACTIVE_COMPARATOR","Participants randomized to the low-dose DMT group (1 mg followed by 4 mg on Day 0) who achieve remission at Day 7 (MADRS ≤10) receive no further dosing and enter long-term follow-up.",[23],"Drug: N,N-Dimethyltryptamine (1 mg + 4 mg)",{"label":25,"type":20,"description":26,"interventionNames":27},"Low-Dose DMT → Non-Remitters (Open-Label Re-dosing)","Participants randomized to the low-dose DMT group (1 mg followed by 4 mg on Day 0) who do not achieve remission at Day 7 (MADRS \\>10) receive an open-label high-dose session (15 mg followed by 60 mg) on Day 14 (±3 days), followed by long-term follow-up.",[13,23],[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","N,N-Dimethyltryptamine (15 mg + 60 mg)","Inhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a high-dose regimen (15 mg + 60 mg).",[15,9,25],[35,36],"N,N-dimethyltryptamine","DMT",{"type":30,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"N,N-Dimethyltryptamine (1 mg + 4 mg)","Inhaled N,N-dimethyltryptamine (DMT) administered via a Volcano Medic 2 vaporizer in two inhalations 1 hour apart, using a low-dose regimen (1 mg + 4 mg).",[25,19],[42,36],"N,N-Dimethyltryptamine",null,[45,66,81,96,120],{"facility":46,"status":47,"city":48,"state":49,"zip":43,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hospital de Saúde Mental Professor Frota Pinto","NOT_YET_RECRUITING","Fortaleza","Ceará","Brazil",{"type":52,"coordinates":53},"Point",[54,55],-38.54306,-3.71722,{"lat":55,"lon":54},[58,63],{"name":59,"role":60,"phone":61,"phoneExt":43,"email":62},"Jarbas de Sá Roriz-Filho, MD","CONTACT","+55 85 98206-0526","jarbasroriz@gmail.com",{"name":64,"role":65,"phone":43,"phoneExt":43,"email":43},"Jarbas de Sá Roriz-Filho, PhD","PRINCIPAL_INVESTIGATOR",{"facility":67,"status":47,"city":68,"state":69,"zip":43,"country":50,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)","Salvador","Estado de Bahia",{"type":52,"coordinates":71},[72,73],-38.49096,-12.97563,{"lat":73,"lon":72},[76,80],{"name":77,"role":60,"phone":78,"phoneExt":43,"email":79},"Lucas Quarantini, PhD","+5571992767743","quarantini@gmail.com",{"name":77,"role":65,"phone":43,"phoneExt":43,"email":43},{"facility":82,"status":47,"city":83,"state":83,"zip":43,"country":50,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ)","Rio de Janeiro",{"type":52,"coordinates":85},[86,87],-43.18223,-22.90642,{"lat":87,"lon":86},[90,94],{"name":91,"role":60,"phone":92,"phoneExt":43,"email":93},"Tiago Arruda Sanches, PhD","+55 21 98173-7000","tiago@medicina.ufrj.br",{"name":95,"role":65,"phone":43,"phoneExt":43,"email":43},"Thiago Arruda Sanches, PhD",{"facility":97,"status":98,"city":99,"state":100,"zip":43,"country":50,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Hospital Universitário Onofre Lopes - HUOL - UFRN","RECRUITING","Natal","Rio Grande do Norte",{"type":52,"coordinates":102},[103,104],-35.20944,-5.795,{"lat":104,"lon":103},[107,111,115,117],{"name":108,"role":60,"phone":109,"phoneExt":43,"email":110},"Fernanda Palhano-Fontes, PhD","+5584999435830","fernandapalhano@neuro.ufrn.br",{"name":112,"role":60,"phone":113,"phoneExt":43,"email":114},"Dráulio Barros de Araújo, PhD","+5584991225987","draulio@neuro.ufrn.br",{"name":116,"role":65,"phone":43,"phoneExt":43,"email":43},"Marcelo Falchi-Carvalho, MD",{"name":118,"role":119,"phone":43,"phoneExt":43,"email":43},"Daniel Montanini, MD","SUB_INVESTIGATOR",{"facility":121,"status":47,"city":122,"state":122,"zip":43,"country":50,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Instituto de Psiquiatria - Hospital das Clínicas - IPq - HC - USP","São Paulo",{"type":52,"coordinates":124},[125,126],-46.63611,-23.5475,{"lat":126,"lon":125},[129,133,135],{"name":130,"role":60,"phone":131,"phoneExt":43,"email":132},"Henrique Ribeiro, MD","+55 11 99712-3513","clinicahenriqueribeiro@gmail.com",{"name":134,"role":65,"phone":43,"phoneExt":43,"email":43},"Rodrigo Furlan Damiano, PhD",{"name":130,"role":119,"phone":43,"phoneExt":43,"email":43},{"type":65,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Draulio Barros de Araujo","PhD, Full Professor at Brain Institute (Instituto do Cérebro - ICe), Federal University of Rio Grande do Norte (UFRN)",[140],{"name":141,"class":6},"Financiadora de Estudos e Projetos","100636169",false,"NCT07562191","Inhaled DMT for Major Depressive Disorder","Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial of Inhaled N,N-Dimethyltryptamine (DMT) for Major Depressive Disorder","DMT-MDD","Inclusion Criteria:\n\n* 18 years or older, capable of making decisions, and able to provide informed consent.\n* Major Depressive Disorder (MDD) according to DSM-5 criteria\n* Current depressive episode of moderate to severe intensity\n* Episode duration of at least two weeks\n* Baseline MADRS score ≥ 20\n* No treatment changes (including antidepressants) in the 4 weeks prior to the study\n* Abstain from psychedelics ≥14 days before dosing (D0) and during the 12-month follow-up\n\nExclusion criteria:\n\n* Major cardiac, hepatic, or renal disease; unstable cardiovascular conditions\n* Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma\n* Severe obesity, uncontrolled diabetes, coagulopathy, thyroid disease, or glaucoma\n* Neurological risk (e.g., aneurysm, ↑ICP, epilepsy\u002Fseizures, severe disorders)\n* MAO deficiency or history of serotonin syndrome\n* Pregnant, breastfeeding, positive test, or no effective contraception\n* Secondary depression\n* Cluster B personality disorders (incl. borderline with ≥2 suicidal behaviors in past 12 months) or poor therapeutic rapport\n* Psychotic disorders, MDD with psychotic features, or first-degree family history of psychosis\u002Fbipolar disorder\n* Mania\u002Fhypomania (YMRS ≥8)\n* OCD, dissociative disorders, active PTSD, or decompensated eating disorders\n* Moderate-severe use disorder (past 6 months; except nicotine\u002Fcaffeine)\n* Lifetime ketamine, PCP, psychedelics, or MDMA use disorder\n* Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing\n* Psychedelic trial participation in past 12 months\n* Cognitive impairment affecting valid assessment","ALL","18 Years",{"count":152,"type":153},140,"ESTIMATED","INTERVENTIONAL",[156],"PHASE2","This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD).\n\nThe study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT.\n\nParticipants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.",[159,160,161,162,163],"MDD","Major Depressive Disorder (MDD)","Major Depression","Suicidal Ideation","Suicide",[36,165,35,166,167,168,169,170],"major depressive disorder","psychedelic therapy","inhaled DMT","vaporized DMT","suicidality","non invasive","2026-05-22",{"date":173,"type":174},"2026-05-28","ACTUAL",{"date":176,"type":153},"2026-08-01",{"date":178,"type":153},"2027-08-01",{"name":5,"class":6},5]