[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636169":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":43,"centralContacts":43,"locations":44,"responsibleParty":137,"collaborators":140,"id":143,"slug":43,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":144,"sex":150,"minAge":151,"maxAge":43,"enrollmentInfo":152,"targetDuration":43,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":99,"whyStopped":43,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"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,[45,67,82,97,121],{"facility":46,"status":47,"city":48,"state":49,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Hospital de Saúde Mental Professor Frota Pinto","NOT_YET_RECRUITING","Fortaleza","Ceará","Brazil","BR",{"type":53,"coordinates":54},"Point",[55,56],-38.54306,-3.71722,{"lat":56,"lon":55},[59,64],{"name":60,"role":61,"phone":62,"phoneExt":43,"email":63},"Jarbas de Sá Roriz-Filho, MD","CONTACT","+55 85 98206-0526","jarbasroriz@gmail.com",{"name":65,"role":66,"phone":43,"phoneExt":43,"email":43},"Jarbas de Sá Roriz-Filho, PhD","PRINCIPAL_INVESTIGATOR",{"facility":68,"status":47,"city":69,"state":70,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Complexo Hospitalar Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)","Salvador","Estado de Bahia",{"type":53,"coordinates":72},[73,74],-38.49096,-12.97563,{"lat":74,"lon":73},[77,81],{"name":78,"role":61,"phone":79,"phoneExt":43,"email":80},"Lucas Quarantini, PhD","+5571992767743","quarantini@gmail.com",{"name":78,"role":66,"phone":43,"phoneExt":43,"email":43},{"facility":83,"status":47,"city":84,"state":84,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB-UFRJ)","Rio de Janeiro",{"type":53,"coordinates":86},[87,88],-43.18223,-22.90642,{"lat":88,"lon":87},[91,95],{"name":92,"role":61,"phone":93,"phoneExt":43,"email":94},"Tiago Arruda Sanches, PhD","+55 21 98173-7000","tiago@medicina.ufrj.br",{"name":96,"role":66,"phone":43,"phoneExt":43,"email":43},"Thiago Arruda Sanches, PhD",{"facility":98,"status":99,"city":100,"state":101,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Hospital Universitário Onofre Lopes - HUOL - UFRN","RECRUITING","Natal","Rio Grande do Norte",{"type":53,"coordinates":103},[104,105],-35.20944,-5.795,{"lat":105,"lon":104},[108,112,116,118],{"name":109,"role":61,"phone":110,"phoneExt":43,"email":111},"Fernanda Palhano-Fontes, PhD","+5584999435830","fernandapalhano@neuro.ufrn.br",{"name":113,"role":61,"phone":114,"phoneExt":43,"email":115},"Dráulio Barros de Araújo, PhD","+5584991225987","draulio@neuro.ufrn.br",{"name":117,"role":66,"phone":43,"phoneExt":43,"email":43},"Marcelo Falchi-Carvalho, MD",{"name":119,"role":120,"phone":43,"phoneExt":43,"email":43},"Daniel Montanini, MD","SUB_INVESTIGATOR",{"facility":122,"status":47,"city":123,"state":123,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Instituto de Psiquiatria - Hospital das Clínicas - IPq - HC - USP","São Paulo",{"type":53,"coordinates":125},[126,127],-46.63611,-23.5475,{"lat":127,"lon":126},[130,134,136],{"name":131,"role":61,"phone":132,"phoneExt":43,"email":133},"Henrique Ribeiro, MD","+55 11 99712-3513","clinicahenriqueribeiro@gmail.com",{"name":135,"role":66,"phone":43,"phoneExt":43,"email":43},"Rodrigo Furlan Damiano, PhD",{"name":131,"role":120,"phone":43,"phoneExt":43,"email":43},{"type":66,"investigatorFullName":138,"investigatorTitle":139,"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)",[141],{"name":142,"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":153,"type":154},140,"ESTIMATED","INTERVENTIONAL",[157],"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.",[160,161,162,163,164],"MDD","Major Depressive Disorder (MDD)","Major Depression","Suicidal Ideation","Suicide",[36,166,35,167,168,169,170,171],"major depressive disorder","psychedelic therapy","inhaled DMT","vaporized DMT","suicidality","non invasive","2026-05-22",{"date":174,"type":175},"2026-05-28","ACTUAL",{"date":177,"type":154},"2026-08-01",{"date":179,"type":154},"2027-08-01",{"name":5,"class":6},5]