{"ctNumber":"2025-523346-27-00","ctStatus":"Authorised","startDateEU":"2026-08-15","decisionDate":"2026-08-14T22:00:55.068","publishDate":"2026-08-17T03:30:50.171576331","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":137732,"rowSubjectCount":0,"products":[{"id":573474,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"13916996","productPharmForm":"GOCCE ORALI, SOLUZIONE","euMpNumber":"PRD1612893","marketingAuthNumber":"022323099","prodAuthStatus":2,"prodName":"TRITTICO 60 mg/ml gocce orali, soluzione","pharmForm":"ORAL DROPS, SOLUTION","activeSubstanceName":"TRAZODONE HYDROCHLORIDE","euSubstNumber":"SUB15596MIG","authorisationCountryCode":"IT","nameOrg":"ANGELINI PHARMA S.P.A.","productSubstances":[{"productPk":"13916996","substancePk":"421421","nameOrg":"ANGELINI PHARMA S.P.A.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"TRAZODONE HYDROCHLORIDE","substanceEvCode":"SUB15596MIG"}],"atcCode":"N06AX05","atcName":"TRAZODONE","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"75","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"75","productChangedRelationMA":false,"maxTreatmentPeriod":1,"timeUnitCode":"1","evCode":"PRD1612893","devices":[],"characteristics":[],"routes":["ORAL"],"allSubstancesChemicals":true,"productName":"TRITTICO 60 mg/ml gocce orali, soluzione","jsonActiveSubstanceNames":"trazodone hydrochloride","pharmaceuticalFormDisplay":"ORAL DROPS, SOLUTION"},{"id":573473,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11834253","productPharmForm":"CAPSULE","euMpNumber":"PRD11829228","prodAuthStatus":1,"prodName":"PEX010 Psilocybin Capsules (25mg psilocybin)","pharmForm":"CAPSULE","sponsorProductCode":"PEX010","activeSubstanceName":"DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: METHANOL","euSubstNumber":"SUB267722","nameOrg":"UNIVERSITA' DEGLI STUDI G. 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The primary objectives include evaluating the safety, tolerability, pharmacokinetics, and dose-finding of trazodone in combination with psilocybin, as well as exploring its potential to modulate psilocybin’s consciousness-altering effects. These aims reflect an exploratory therapeutic objective rather than early-phase pharmaceutical development or post-marketing use. The trial design, which involves small patient cohorts, dose escalation, and a sentinel safety strategy, aligns with the characteristics of early therapeutic exploratory research. It is not a Phase I bioequivalence or pharmacology study, nor a large-scale confirmatory or post-authorisation trial, which excludes Categories 1 and 3. Therefore, based on its phase, objectives, and study population, the trial fits appropriately into Category 2 – Therapeutic exploratory and confirmatory clinical trials.","trialCategoryId":127198},"medicalCondition":{"partIMedicalConditions":[{"id":144150,"medicalCondition":"Treatment-Resistant Depression","medicalConditionTranslations":[{"id":11593892,"uuid":"f145f789-e6a7-464e-b30d-d97f225c3e15","attributeTranslation":"Depressione Resistente al Trattamento","language":14,"languageDescription":"Italian"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":200000031165,"version":"26.0","level":"LLT","termName":"Treatment resistant depression","classificationCode":"10088521","organClass":100000004848,"active":false}]},"trialObjective":{"trialScopes":[{"code":"9","trialScopeId":418527},{"code":"4","trialScopeId":418529},{"code":"6","trialScopeId":418528}],"mainObjective":"To evaluate the safety, tolerability, and feasibility of escalating doses of trazodone administered prior to a fixed dose of psilocybin in individuals with TRD.","mainObjectiveTranslations":[{"id":11593895,"uuid":"0bb7ecdd-c865-489d-981e-577092bb91a8","attributeTranslation":"Valutare la sicurezza e tollerabilità di diverse dosi e formulazioni di trazodone somministrate in combinazione con una dose fissa di psilocibina (25 mg) in individui con depressione resistente al trattamento.","language":14,"languageDescription":"Italian"}],"secondaryObjectives":[{"id":491363,"number":1,"secondaryObjective":"1) To explore preliminary attenuation-related signals of psilocybin-induced subjective effects using validated psychometric tools used in previous clinical trials with psilocybin and other psychedelics. These data will be interpreted as descriptive and hypothesis-generating only, due to the open-label, non-controlled design and the potential influence of expectation bias. 2) To characterize the PK profiles of psilocybin, its metabolite psilocin, trazodone, and its metabolite mCPP following the co-administration of trazodone and psilocybin. 3) To obtain preliminary information regarding a candidate trazodone dose/formulation associated with potential attenuation of psilocybin-induced subjective effects and acceptable safety and tolerability, to inform the design of a subsequent randomized, double-blind, placebo-controlled trial.","secondaryObjectiveTranslations":[{"id":11593897,"uuid":"9d1a7fc4-f23d-40e5-9f3b-cabe075de77d","attributeTranslation":"-Ottenere informazioni preliminari riguardo la dose minima efficace e la formulazione di trazodone che attenua gli effetti soggettivi psichedelici della psilocibina.\n\n-Caratterizzare i profili farmacocinetici (PK) della psilocibina, il suo metabolite psilocina, trazodone, il suo metabolita mCPP dopo la co-somministrazione di trazodone e psilocibina.\n\n-Ottenere informazioni preliminari sulla dose/formulazione ottimale di trazodone in grado di determinare la maggiore attenuazione degli effetti psichedelici della psilocibina con la più bassa incidenza di eventi avversi (AE) ed eventi avversi emergenti dal trattamento (TEAE).","language":14,"languageDescription":"Italian"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":936603,"number":1,"principalInclusionCriteria":"Age: Individuals aged between 18 and 65 years","principalInclusionCriteriaTranslations":[]},{"id":936604,"number":10,"principalInclusionCriteria":"Fluency in language: Participants must be fluent in the language in which study assessments are administered (Italian)","principalInclusionCriteriaTranslations":[]},{"id":936605,"number":11,"principalInclusionCriteria":"Compliance: Participants must be willing and able to comply with all study procedures, including five study visits, blood and urine sampling, pregnancy and toxicological screening, and completion of psychometric assessments","principalInclusionCriteriaTranslations":[]},{"id":936606,"number":2,"principalInclusionCriteria":"Diagnosis of TRD: Participants must have a diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria. Additionally, subjects should be non-responders to at least two antidepressant medications at adequate doses (i.e., SSRIs, SNRIs, or equivalent) administered for a duration of 4-6 weeks.","principalInclusionCriteriaTranslations":[]},{"id":936607,"number":3,"principalInclusionCriteria":"Hospitalization Status: Hospitalized patients or those receiving outpatient care, as assessed by the investigator’s clinical judgment, may be included if they meet other inclusion criteria","principalInclusionCriteriaTranslations":[]},{"id":936608,"number":4,"principalInclusionCriteria":"Informed Consent: Patients must be able and willing to provide written informed consent to participate in the study","principalInclusionCriteriaTranslations":[]},{"id":936609,"number":5,"principalInclusionCriteria":"Agreement to Use Highly Effective Contraception Methods: For patients of childbearing potential, agreement to use adequate contraception methods during the course of the study and for a defined period after study completion (see section “CONTRACEPTION REQUIREMENTS”)","principalInclusionCriteriaTranslations":[]},{"id":936610,"number":6,"principalInclusionCriteria":"No Major Substance Abuse: Participants should not have a history of severe substance use disorder within the past year (e.g., alcohol, illicit drugs) that might interfere with the study protocol or outcomes","principalInclusionCriteriaTranslations":[]},{"id":936611,"number":7,"principalInclusionCriteria":"Antidepressants discontinuation: Patients have discontinued any monoaminergic psychiatric medication (i.e. SSRIs, SNRIs) for at least 2 weeks (fluoxetine: 5 weeks) before the first dosing session. Patients who are still on any monoaminergic psychiatric medication at screening must agree to down-titrate over an individualized down-titration schedule in close supervision by their out-patient psychiatrist and the study team. The treating psychiatrist must agree to supervise and monitor the down-titration and to collaborate with the study team","principalInclusionCriteriaTranslations":[]},{"id":936612,"number":8,"principalInclusionCriteria":"Current use of monoamine oxidase inhibitors (MAOIs). Patients can be enrolled if the MAOI treatment will be completely discontinued following tapering at least 2 weeks prior to baseline visiit","principalInclusionCriteriaTranslations":[]},{"id":936613,"number":9,"principalInclusionCriteria":"BMI and body weight: Participants must have a body mass index (BMI) between 18.0 and 30.0 kg/m² and weigh at least 45 kg at screening","principalInclusionCriteriaTranslations":[]}],"principalExclusionCriteria":[{"id":1600529,"number":1,"principalExclusionCriteria":"Current comorbidity with, or a previous diagnosis of, any of the following DSM-5 disorders: Major depressive disorder with psychotic features (ICD- 10: F32.3). Schizophrenia spectrum and other psychotic disorders, including schizotypal (personality) disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition (ICD-10: F20–F29). Bipolar and related disorders (ICD-10: F30/F31). Cluster A personality disorders (paranoid, schizoid, schizotypal) and/or borderline personality disorder; screening for these disorders will be performed using the SCID-5-PD. Post-traumatic stress disorder (PTSD; ICD-10: F43.1)","principalExclusionCriteriaTranslations":[{"id":11593893,"uuid":"fd61d744-74ec-4072-9068-18cac4da2d14","attributeTranslation":"Comorbidità attuale o diagnosi pregressa di uno dei seguenti disturbi secondo DSM-5:\n\nDisturbo depressivo maggiore con caratteristiche psicotiche (ICD-10: F32.3).\n\nDisturbi dello spettro della schizofrenia e altri disturbi psicotici, inclusi disturbo schizotipico (di personalità), disturbo delirante, disturbo psicotico breve, disturbo schizofreniforme, disturbo schizoaffettivo, disturbo psicotico indotto da sostanze/farmaci o disturbo psicotico dovuto a altra condizione medica (ICD-10: F20–F29).\n\nDisturbi bipolari e correlati (ICD-10: F30/F31).\n\nDisturbi di personalità Cluster A (paranoide, schizoid, schizotipico) e/o disturbo borderline di personalità; lo screening sarà effettuato tramite SCID-5-PD.\n\nDisturbo da stress post-traumatico (PTSD; ICD-10: F43.1).\n\nStoria familiare di psicosi e/o disturbo bipolare in un parente di primo grado.\n\nIdeazione suicidaria clinicamente significativa attuale o recente (ultimi 6 mesi), corrispondente a un punteggio di 4 (ideazione attiva con qualche intenzione di agire, senza piano specifico) o 5 (ideazione attiva con piano e intenzione specifica) sulla Columbia–Suicide Severity Rating Scale (C-SSRS), o storia di comportamento suicidario nell’ultimo anno, valutata durante lo screening con C-SSRS.\n\nI soggetti con un tentativo di suicidio precedente o ideazione/piano serio avvenuto più di 6 mesi fa saranno sottoposti a screening accurato e potranno essere inclusi solo a discrezione dell’investigatore.\n\nPresenza di disturbo da uso di sostanze attuale o recente (ultimi 12 mesi), esclusi disturbi correlati a tabacco o caffeina.\n\nUso di psichedelici classici (LSD, psilocibina, mescalina, dimetiltriptamina) nell’ultimo anno, o più di cinque usi nella vita.\n\nAlto rischio cardiovascolare secondo gli algoritmi SCORE2.\n\nIpertensione intracranica, ipertensione polmonare, ipertensione arteriosa non corretta (PA >150/100 mmHg).\n\nStoria di ictus o infarto miocardico negli ultimi 6 mesi.\n\nInsufficienza cardiaca.\n\nAltre malattie somatiche gravi o condizioni in cui un aumento significativo della pressione arteriosa comporterebbe un serio rischio per la salute (da valutare dal medico dello studio).\n\nGlaucoma.\n\nDiagnosi consolidata di epilessia o storia familiare positiva di disturbi epilettici.\n\nIncapacità di stabilire un adeguato rapporto terapeutico con entrambi i terapisti dello studio, come determinato dopo le prime due sessioni preparatorie.\n\nGravidanza o allattamento, o pianificazione di gravidanza entro i prossimi 3 mesi.\n\nAllergia a uno qualsiasi dei componenti dei farmaci dello studio.\n\nDisturbi endocrini o metabolici non controllati, inclusi:\n\nIpertiroidismo non trattato o scompensato.\n\nGrave insufficienza respiratoria o depressione respiratoria acuta.\n\nCondizioni neurologiche, inclusi:\n\nDiagnosi consolidata di epilessia o storia familiare nota di crisi epilettiche.\n\nGrave malattia somatica o qualsiasi condizione che, a giudizio dell’investigatore, aumenterebbe il rischio o interferirebbe con il protocollo dello studio.\n\nAllergia nota o ipersensibilità a psilocibina, trazodone o eccipienti dei farmaci dello studio.\n\nUso di farmaci o sostanze proibite, salvo che sia stato completato un appropriato periodo di washout (minimo 7–14 giorni) prima della somministrazione.","language":14,"languageDescription":"Italian"}]},{"id":1600530,"number":10,"principalExclusionCriteria":"Inability to establish sufficient therapeutic rapport with both study therapists, as determined after the first two preparatory sessions","principalExclusionCriteriaTranslations":[]},{"id":1600531,"number":11,"principalExclusionCriteria":"Pregnancy or breast-feeding or plan to become pregnant within the next 3 months","principalExclusionCriteriaTranslations":[]},{"id":1600532,"number":12,"principalExclusionCriteria":"Allergy to any of the components of study drugs","principalExclusionCriteriaTranslations":[]},{"id":1600533,"number":13,"principalExclusionCriteria":"Uncontrolled endocrine or metabolic disorders, including: Untreated or decompensated hyperthyroidism Severe respiratory failure or acute respiratory depression Neurological conditions, including: Established diagnosis of epilepsy or a known family history of epileptic seizures","principalExclusionCriteriaTranslations":[]},{"id":1600534,"number":14,"principalExclusionCriteria":"Severe somatic illness or any condition that, in the investigator's opinion, would increase risk or interfere with the study protocol","principalExclusionCriteriaTranslations":[]},{"id":1600535,"number":15,"principalExclusionCriteria":"Known allergy or hypersensitivity to psilocybin, trazodone, or any excipients in the study drugs","principalExclusionCriteriaTranslations":[]},{"id":1600536,"number":16,"principalExclusionCriteria":"Use of prohibited medications or substances, unless an appropriate washout period (minimum 7–14 days) is completed prior to dosing.","principalExclusionCriteriaTranslations":[]},{"id":1600537,"number":2,"principalExclusionCriteria":"A family history of psychosis and/or bipolar disorder in a first-degree relative","principalExclusionCriteriaTranslations":[]},{"id":1600538,"number":3,"principalExclusionCriteria":"Current or recent history (within the past 6 months) of clinically significant suicidal ideation, corresponding to a score of 4 (active suicidal ideation with some intent to act, without a specific plan) or 5 (active suicidal ideation with specific plan and intent) on the Columbia–Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as assessed during screening using the C-SSRS. Subjects with a prior suicide attempt or serious suicidal ideation/plan occurring more than 6 months ago should undergo careful screening and may only be included at the investigator’s discretion","principalExclusionCriteriaTranslations":[]},{"id":1600539,"number":4,"principalExclusionCriteria":"Presence of a current comorbid substance use disorder within the past 12 months (excluding tobacco- or caffeine-related disorders)","principalExclusionCriteriaTranslations":[]},{"id":1600540,"number":5,"principalExclusionCriteria":"Use of classical psychedelics (LSD, psilocybin, mescaline, dimethyltryptamine) within the past year, or more than five lifetime uses of classical psychedelics","principalExclusionCriteriaTranslations":[]},{"id":1600541,"number":6,"principalExclusionCriteria":"High cardiovascular risk according to the SCORE2 risk prediction algorithms. Intracranial hypertension, pulmonary hypertension, uncorrected arterial hypertension (BP> 150/100 mmHg). History of stroke or myocardial infarction within the last 6 months Heart failure","principalExclusionCriteriaTranslations":[]},{"id":1600542,"number":7,"principalExclusionCriteria":"Pulmonary or intracranial hypertension","principalExclusionCriteriaTranslations":[]},{"id":1600543,"number":8,"principalExclusionCriteria":"Other serious somatic diseases or any other circumstance in which a significant increase in blood pressure would pose a serious threat to health (to be assessed by the study clinician)","principalExclusionCriteriaTranslations":[]},{"id":1600544,"number":9,"principalExclusionCriteria":"Established diagnosis of epilepsy or a positive familial history of epileptic disorders","principalExclusionCriteriaTranslations":[]}]},"endPoint":{"primaryEndPoints":[{"id":1094402,"number":1,"endPoint":"Safety and tolerability of trazodone administered prior to psilocybin, evaluated through: -Incidence, severity, and relationship of treatment-emergent adverse events from dosing through Day 30. -Occurrence of dose-limiting toxicities within 24 hours after psilocybin-trazodone co/administration. - Clinically significant changes in vital signs, ECG, and laboratory parameters. -Emergence or worsening of suicidal ideation or behavior assessed using the Columbia–Suicide Severity Rating Scale (C-SSRS)","isPrimary":true,"endPointTranslations":[]}],"secondaryEndPoints":[{"id":1094403,"number":1,"endPoint":"Exploratory assessment of psilocybin-induced subjective effects and preliminary attenuation-related signals, assessed using validated psychometric questionnaires, including the 5D-ASC and EBI. These endpoints will be interpreted as descriptive and hypothesis-generating only.","isPrimary":false,"endPointTranslations":[]},{"id":1094404,"number":2,"endPoint":"Pharmacokinetic characterization of psilocybin, psilocin, trazodone, and mCPP following co-administration.","isPrimary":false,"endPointTranslations":[]},{"id":1094405,"number":3,"endPoint":"Identification of a candidate trazodone dose/formulation for further controlled evaluation, based on the integrated assessment of safety, tolerability, PK data, and exploratory subjective pharmacodynamic outcomes.","isPrimary":false,"endPointTranslations":[]}]},"trialDuration":{"estimatedEndDate":"2026-12-31","estimatedRecruitmentStartDate":"2026-05-01"},"sourceOfMonetarySupport":[{"id":101270,"organisationName":"Italian Ministry of Health, funded by the European Union “NextGenerationEU” 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