[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Federal University of Latin American Integration\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"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":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25,26],"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.",[29],"Depressive Disorder",[31,32,33,34,35],"Psilocybin","Depression","Fluoxetine","Treatment","Psychedelics","RECRUITING","2026-03-23",{"date":39,"type":40},"2026-03-27","ACTUAL",{"date":42,"type":40},"2024-09-05",{"date":44,"type":22},"2026-11-20",{"name":46,"class":47},"Federal University of Latin American Integration","OTHER",""]