[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585149":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":46,"locations":51,"responsibleParty":67,"collaborators":28,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":28,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":53,"whyStopped":28,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Federal University of Latin American Integration","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Psilocybin + Fluoxetine","EXPERIMENTAL","2 preparation sessions for the psychedelic experience\n\n1. dosing session with 3g Psilocybe mushrooms (single oral dose), with psychotherapy assistance\n2. integration sessions Fluoxetine 20 mg\u002Fday for 4 weeks (started 2 weeks before dosing and continued 2 weeks after)",[13,14,15],"Drug: Psilocybin and Psilocyn","Behavioral: Psychotherapy-assisted session","Drug: Fluoxetine",{"label":17,"type":18,"description":19,"interventionNames":20},"Psilocybin + Placebo","PLACEBO_COMPARATOR","2 preparation sessions for the psychedelic experience\n\n1. dosing session with 3g Psilocybe mushrooms (single oral dose), with psychotherapy assistance\n2. integration sessions Pharmaceutical grade talc, matching placebo (identical capsules), daily for 4 weeks (started 2 weeks before dosing and continued 2 weeks after).",[13,21,14],"Drug: Placebo",[23,29,33,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Psilocybin and Psilocyn","Oral dose administered via Psilocybe mushrooms material batch-assayed by LC-MS to standardize psilocybin and psilocyn content.",[9,17],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Placebo","Matching capsules, once daily for 4 weeks (-14 to +14 days).",[17],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"BEHAVIORAL","Psychotherapy-assisted session","Same manualized procedures as Arm 1.",[9,17],{"type":24,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Fluoxetine","20 mg\u002Fday for 4 weeks (-14 to +14 days relative to dosing day).",[9],[43],{"name":44,"affiliation":5,"role":45},"Francisney P Nascimento, 1","STUDY_DIRECTOR",[47],{"name":44,"role":48,"phone":49,"phoneExt":28,"email":50},"CONTACT","+55 45 99933-3479","ensaios.clinicos.lcp@unila.edu.br",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Foz do Iguaçu","Paraná","85870-650","Brazil","BR",{"type":60,"coordinates":61},"Point",[62,63],-54.58806,-25.54778,{"lat":63,"lon":62},[66],{"name":44,"role":48,"phone":49,"phoneExt":28,"email":50},{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100585149","phase-1-psilocybe-cubensis-mushrooms-with-or-without-fluoxetine-for-refractory-depression-100585149",false,"NCT06898606","Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression","COGUNILA","Inclusion Criteria Age: ≥25 and \\\u003C65 years. Diagnosis: Current Major Depressive Disorder (MDD), moderate to severe, per DSM-5-TR, confirmed with SCID-5.\n\nBaseline severity: MADRS ≥20 at baseline (reassessed at the pre-dose visit to confirm ongoing eligibility).\n\nPartial Response in the current episode (PRD): ≥1 adequate antidepressant trial in this episode (therapeutic dose for ≥6-12 weeks, adherence ≥80%) with \\\u003C50% symptom reduction or clinically significant residual symptoms.\n\nClinical stability and ability to provide informed consent; willingness to comply with all study procedures (preparation, dosing session, integration, and follow-ups).\n\nContraception: For participants with reproductive potential, negative pregnancy test and agreement to use effective contraception during the study.\n\nExclusion Criteria Psychiatric disorders: Bipolar I\u002FII disorder, any psychotic disorder, or current MDD with psychotic features; first-degree family history of psychotic or bipolar disorder.\n\nSuicide risk: Acute suicidal risk, e.g., active suicidal ideation with intent or plan, recent attempt, or clinical judgment requiring urgent intervention.\n\nInteracting medications: Current use of serotonergic antidepressants (SSRI\u002FSNRI\u002FMAOI, clomipramine) or other pro-serotonergic agents (e.g., triptans, linezolid, lithium, tramadol, dextromethorphan) that cannot be discontinued per protocol-defined washout.\n\nOther psychotropics: Unstable doses of antipsychotics, mood stabilizers, or long-acting benzodiazepines within the last 2 weeks; need for medications that would compromise blinding on the dosing day.\n\nPsychotherapy changes: Initiation or major change in psychotherapy within 2 weeks prior to baseline (to preserve clinical stability).\n\nMedical conditions: Clinically significant or unstable medical illness (cardiovascular, neurological, hepatic, renal), prolonged QTc, known hypersensitivity\u002Fcontraindication to fluoxetine or study materials.\n\nPregnancy or breastfeeding. Substance use: Current substance use disorder (excluding nicotine\u002Fcaffeine) within the past 3 months; non-medical cannabis use that cannot meet the pre-dose abstinence window (e.g., ≥72 h).\n\nAny condition that, in the investigator's opinion, would make participation unsafe or interfere with the assessments.\n\nWashout note (to include in Procedures\u002FEligibility):\n\nSSRIs\u002FSNRIs: 7 days or ≥5 half-lives; prior fluoxetine: ≥6 weeks; MAOIs: ≥14 days before randomization\u002Fdosing. Participants must be willing and able to follow the washout schedule.",true,"ALL","25 Years","65 Years",{"count":81,"type":82},24,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a psychedelic-assisted psychotherapy session in adults with treatment-resistant major depressive disorder (TRD). Eligible participants (ages 25-64) have DSM-5-TR MDD, moderate-severe, MADRS ≥20, and partial response in the current episode (≥1 adequate antidepressant trial of 6-12 weeks with \\\u003C50% symptom reduction). All participants receive one dosing session with 3g of standardized Psilocybe mushrooms - with batch assay (e.g., LC-MS) to determine the amount of psilocybin and psilocin present in the sample - with manualized preparation and integration. Participants are randomized 1:1 to fluoxetine 20 mg\u002Fday or matching placebo for 4 weeks, started 2 weeks before the psychedelic session and continued 2 weeks after. Masking is quadruple (participant, care provider, investigator, outcomes assessor). The primary outcome is change in MADRS from Baseline to Week 4, assessed by a remote, blinded rater. Key secondary outcomes include response (≥50% MADRS reduction) and remission (MADRS ≤10) at Week 4, and durability at Week 6. Exploratory outcomes assess the psychedelic experience (5D-ASC, SOCQ), psychological flexibility (AAQ-10), and safety\u002Ftolerability (UKU and adverse events). Findings will be interpreted as estimates with 95% confidence intervals to inform the design of a subsequent confirmatory trial.",[89],"Depressive Disorder",[91,92,39,93,94],"Psilocybin","Depression","Treatment","Psychedelics","2026-03-23",{"date":97,"type":98},"2026-03-27","ACTUAL",{"date":100,"type":98},"2024-09-05",{"date":102,"type":82},"2026-11-20",{"name":5,"class":6},1]