{"ctNumber":"2024-519270-40-00","ctStatus":"Authorised","startDateEU":"2025-10-30","decisionDate":"2025-08-05T10:40:47.033","publishDate":"2026-11-07T02:39:11.443338358","ctPublicStatusCode":5,"authorizedApplication":{"authorizedPartI":{"id":145536,"rowSubjectCount":189,"rowCountriesInfo":[{"eutctId":100000000556,"name":"United Kingdom","isoNumber":826,"isoAlpha2Code":"GB","isoAlpha3Code":"GBR","current":true},{"eutctId":100000000354,"name":"Canada","isoNumber":124,"isoAlpha2Code":"CA","isoAlpha3Code":"CAN","current":true},{"eutctId":100000000329,"name":"Australia","isoNumber":36,"isoAlpha2Code":"AU","isoAlpha3Code":"AUS","current":true},{"eutctId":100000000557,"name":"United States","isoNumber":840,"isoAlpha2Code":"US","isoAlpha3Code":"USA","current":true}],"products":[{"id":608377,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12374756","productPharmForm":"CAPSULE","euMpNumber":"PRD12118023","prodAuthStatus":1,"prodName":"CYB003","pharmForm":"CAPSULE","sponsorProductCode":"CYB003","activeSubstanceName":"DEUPSILOCIN BESILATE","euSubstNumber":"SUB370808","productOtherName":"deupsilocin","nameOrg":"CYBIN IRL LIMITED","productSubstances":[{"productPk":"12374756","substancePk":"409339","nameOrg":"CYBIN IRL LIMITED","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"DEUPSILOCIN BESILATE","substanceEvCode":"SUB370808"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"8","doseUomTotal":"mg 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BESILATE","substanceEvCode":"SUB370808"}],"atcCode":"NOTASSIGN","atcName":"-","atcTermLevel":"","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"16","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"32","maxTreatmentPeriod":3,"timeUnitCode":"2","evCode":"PRD11770196","sponsorProductCodeEdit":"CYB003","miaNumber":"The same for 8mg, 16mg CYB003 and matching placebo (uploaded under CYB003 8mg)","devices":[],"characteristics":["2"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"CYB003","jsonActiveSubstanceNames":"deupsilocin besilate","pharmaceuticalFormDisplay":"CAPSULE"},{"id":608378,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPharmForm":"N/A","euMpNumber":"N/A","marketingAuthNumber":"N/A","prodName":"Placebo","pharmForm":"N/A","activeSubstanceName":"N/A","euSubstNumber":"N/A","productOtherName":"N/A","authorisationCountryCode":"IS","nameOrg":"N/A","sponsorSubstanceCode":"N/A","atcCode":"N/A","atcName":"N/A","atcTermLevel":"N/A","activeSubstanceOtherDescriptiveName":"N/A"},"isPaediatricFormulation":false,"mpRoleInTrial":"3","orphanDrugEdit":false,"timeUnitCode":"2","evCode":"N/A","miaNumber":"Same for 8mg, 16mg CYB003 and matching placebo (uploaded under CYB003 8mg)","devices":[],"characteristics":[],"routes":[],"allSubstancesChemicals":false,"productName":"Placebo","jsonActiveSubstanceNames":"n/a","pharmaceuticalFormDisplay":"N/A"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants with Major Depressive Disorder (EMBRACE)","fullTitleTranslations":[{"id":12394153,"uuid":"53bf8bd5-e6ee-415a-8066-2f244f57acf9","attributeTranslation":"Multicentrické, dvojitě zaslepené, randomizované kontrolované klinické hodnocení fáze III porovnávající účinnost a bezpečnost 2 účinných dávek přípravku CYB003 a placeba u vhodných účastníků s depresivní poruchou (EMBRACE)","language":2,"languageDescription":"Czech"},{"id":12394154,"uuid":"53bf8bd5-e6ee-415a-8066-2f244f57acf9","attributeTranslation":"Πολυκεντρική, διπλά τυφλή, τυχαιοποιημένη και ελεγχόμενη μελέτη φάσης III για αξιολόγηση της αποτελεσματικότητας και της ασφάλειας, η οποία συγκρίνει δύο δραστικές δόσεις του CYB003 με εικονικό φάρμακο σε συμμετέχοντες με μείζονα καταθλιπτική διαταραχή που πληρούν τα κριτήρια (EMBRACE)","language":32,"languageDescription":"Greek (Greece)"},{"id":12394152,"uuid":"53bf8bd5-e6ee-415a-8066-2f244f57acf9","attributeTranslation":"Wieloośrodkowe, prowadzone metodą podwójnie ślepej próby z grupą kontrolną, randomizowane badanie fazy III dotyczące skuteczności i bezpieczeństwa stosowania, porównujące 2 aktywne dawki CYB003 i placebo u kwalifikujących się uczestników z ciężkim zaburzeniem depresyjnym (EMBRACE).","language":19,"languageDescription":"Polish"},{"id":12394151,"uuid":"53bf8bd5-e6ee-415a-8066-2f244f57acf9","attributeTranslation":"Eine multizentrische, doppelblinde, randomisierte, kontrollierte Wirksamkeits- und Sicherheitsstudie der Phase III zum Vergleich von 2 aktiven CYB003-Dosen und Placebo bei geeigneten Teilnehmern mit schwerer depressiver Störung (EMBRACE)","language":4,"languageDescription":"German"}],"publicTitle":"A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder","publicTitleTranslations":[{"id":12394184,"uuid":"c8058b0b-0c10-4248-b846-718c2ac05505","attributeTranslation":"Δοκιμή φάσης 3 για αξιολόγηση του CYB003 στη μείζονα καταθλιπτική διαταραχή","language":32,"languageDescription":"Greek (Greece)"},{"id":12394186,"uuid":"c8058b0b-0c10-4248-b846-718c2ac05505","attributeTranslation":"Klinické hodnocení fáze 3 k posouzení přípravku CYB003 u velké depresivní poruchy","language":2,"languageDescription":"Czech"},{"id":12394185,"uuid":"c8058b0b-0c10-4248-b846-718c2ac05505","attributeTranslation":"Eine Phase-III-Prüfung zur Bewertung von CYB003 bei schwerer depressiver Störung","language":4,"languageDescription":"German"},{"id":12394183,"uuid":"c8058b0b-0c10-4248-b846-718c2ac05505","attributeTranslation":"Badanie fazy III mające na celu ocenę stosowania CYB003 w dużym zaburzeniu depresyjnym","language":19,"languageDescription":"Polish"}],"shortTitle":"CYB003-003","secondaryIdentifyingNumbers":{"nctNumber":{"id":584441,"number":"NCT06793397"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"This is a Phase III, Double-Blind, Randomized Controlled Study","trialCategoryId":134795},"medicalCondition":{"partIMedicalConditions":[{"id":152724,"medicalCondition":"Major Depressive Disorder","medicalConditionTranslations":[{"id":12394063,"uuid":"3040645b-b282-40dc-9c39-3b01ec467b3b","attributeTranslation":"Μείζονα Καταθλιπτική Διαταραχή","language":32,"languageDescription":"Greek (Greece)"},{"id":12394064,"uuid":"3040645b-b282-40dc-9c39-3b01ec467b3b","attributeTranslation":"Ciężkie zaburzenie depresyjne","language":19,"languageDescription":"Polish"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":200000009016,"version":"21.1","level":"LLT","termName":"Major depressive disorder","classificationCode":"10081270","organClass":10037175,"active":false}]},"trialObjective":{"trialScopes":[{"code":"4","trialScopeId":443207},{"code":"9","trialScopeId":443206},{"code":"5","trialScopeId":443205}],"mainObjective":"To assess the efficacy of 2 administrations of IP compared to placebo in treating symptoms of MDD in adult participants.","mainObjectiveTranslations":[{"id":12394181,"uuid":"c7f9fa0c-410e-40a2-865e-c15ac4044119","attributeTranslation":"Ocena skuteczności 2 podań badanego produktu (IP) w porównaniu z placebo w leczeniu objawów MDD u dorosłych uczestników","language":19,"languageDescription":"Polish"},{"id":12394182,"uuid":"c7f9fa0c-410e-40a2-865e-c15ac4044119","attributeTranslation":"Για την αξιολόγηση της αποτελεσματικότητας 2 χορηγήσεων του ΥΕΠ σε σύγκριση με εικονικό φάρμακο στη θεραπεία των συμπτωμάτων της ΜΚΔ σε ενήλικες συμμετέχοντες","language":32,"languageDescription":"Greek (Greece)"}],"secondaryObjectives":[{"id":522773,"number":1,"secondaryObjective":"To assess longer-term efficacy of 2 administrations of IP compared to placebo in treating symptoms of MDD in adult participants.","secondaryObjectiveTranslations":[{"id":12394188,"uuid":"fb27933e-f476-4aa0-9568-a145a5b16244","attributeTranslation":"Για την αξιολόγηση της μακροπρόθεσμης αποτελεσματικότητας 2 χορηγήσεων του ΥΕΠ σε σύγκριση με εικονικό φάρμακο στη θεραπεία των συμπτωμάτων της ΜΚΔ σε ενήλικες συμμετέχοντες","language":32,"languageDescription":"Greek (Greece)"},{"id":12394187,"uuid":"fb27933e-f476-4aa0-9568-a145a5b16244","attributeTranslation":"Ocena długoterminowej skuteczności 2 podań IP w porównaniu z placebo w leczeniu objawów MDD u dorosłych uczestników","language":19,"languageDescription":"Polish"}]},{"id":522774,"number":2,"secondaryObjective":"To further assess the efficacy of IP compared to placebo.","secondaryObjectiveTranslations":[{"id":12394189,"uuid":"5a40aa29-2814-4baa-a61a-7704d9e65829","attributeTranslation":"Για περαιτέρω αξιολόγηση της αποτελεσματικότητας του ΥΕΠ σε σύγκριση με εικονικό φάρμακο","language":32,"languageDescription":"Greek (Greece)"},{"id":12394190,"uuid":"5a40aa29-2814-4baa-a61a-7704d9e65829","attributeTranslation":"Dalsza ocena skuteczności IP w porównaniu z placebo","language":19,"languageDescription":"Polish"}]},{"id":522775,"number":3,"secondaryObjective":"To determine the effect of 2 administrations of IP compared to placebo on symptoms of depression, as assessed by participants; global disease severity, anxiety, and quality of life.","secondaryObjectiveTranslations":[{"id":12394192,"uuid":"42ddfb7d-e1a3-4337-a2f0-6844ae50e6df","attributeTranslation":"Για τον προσδιορισμό της επίδρασης 2 χορηγήσεων του ΥΕΠ σε σύγκριση με εικονικό φάρμακο στα συμπτώματα της κατάθλιψης, όπως αξιολογήθηκαν από τους συμμετέχοντες: γενική βαρύτητα της νόσου, άγχος και ποιότητα ζωής","language":32,"languageDescription":"Greek (Greece)"},{"id":12394191,"uuid":"42ddfb7d-e1a3-4337-a2f0-6844ae50e6df","attributeTranslation":"Określenie wpływu 2 podań IP w porównaniu z placebo na objawy depresji, oceniane przez uczestników, ogólne nasilenie choroby, lęk i jakość życia","language":19,"languageDescription":"Polish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":993464,"number":1,"principalInclusionCriteria":"Aged 18 to 85 years inclusive, at Screening.","principalInclusionCriteriaTranslations":[{"id":12394156,"uuid":"ffc3a43b-41ba-44b7-90d3-4936b3858cc0","attributeTranslation":"Być w wieku od 18 do 85 lat włącznie, podczas badań przesiewowych.","language":19,"languageDescription":"Polish"},{"id":12394155,"uuid":"ffc3a43b-41ba-44b7-90d3-4936b3858cc0","attributeTranslation":"Είναι ηλικίας από 18 έως και 85 ετών κατά τη διαλογή.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":993465,"number":10,"principalInclusionCriteria":"If the participant is engaged and planning to remain in a psychotherapeutic relationship, it must be stable and consistent for at least 4 weeks prior to Screening. Minor adjustments in frequency or setting are permissible, provided they do not represent a substantial change in the therapeutic modality.","principalInclusionCriteriaTranslations":[{"id":12394157,"uuid":"476c41e8-aa45-4e1f-a90b-74de2d6d98bc","attributeTranslation":"Jeśli uczestnik pozostaje w relacji psychoterapeutycznej, musi ona być stabilna i stała przez co najmniej 12 tygodni przed badaniem przesiewowym. Przez cały okres trwania badania nie należy dokonywać żadnych zmian częstotliwości ani ustawień.","language":19,"languageDescription":"Polish"},{"id":12394158,"uuid":"476c41e8-aa45-4e1f-a90b-74de2d6d98bc","attributeTranslation":"Αν κάνουν ψυχοθεραπεία και σκοπεύουν να τη συνεχίσουν, αυτή πρέπει να είναι σταθερή και συνεπής για τουλάχιστον 4 εβδομάδες πριν από τη διαλογή. Μικρές προσαρμογές ως προς τη συχνότητα ή το πλαίσιο επιτρέπονται, υπό την προϋπόθεση ότι δεν συνιστούν ουσιώδη αλλαγή στη θεραπευτική προσέγγιση.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":993466,"number":11,"principalInclusionCriteria":"Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening.","principalInclusionCriteriaTranslations":[{"id":12394159,"uuid":"2ba4d42e-a385-4ba2-8951-3c544aad9e68","attributeTranslation":"Έχουν δείκτη μάζας σώματος (ΔΜΣ) το πολύ 40 kg/m2 (ΔΜΣ ≤ 40 kg/m2), κατά τη διαλογή.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394160,"uuid":"2ba4d42e-a385-4ba2-8951-3c544aad9e68","attributeTranslation":"Wskaźnik masy ciała (BMI) uczestnika musi wynosić 40 kg/m2 lub poniżej (BMI ≤40 kg/m2), włącznie, w badaniu przesiewowym.","language":19,"languageDescription":"Polish"}]},{"id":993467,"number":12,"principalInclusionCriteria":"Participant is able to refrain from nicotine use during the dosing session (up to 8 hours), as determined by a score of ≤4 on the Fagerström Test for Nicotine Dependence.","principalInclusionCriteriaTranslations":[{"id":12394162,"uuid":"930e348b-ea5b-40e8-bca2-b7ce17199415","attributeTranslation":"Uczestnik jest w stanie powstrzymać się od używania nikotyny w trakcie sesji dawkowania (do 8 godzin), co ustala się na podstawie wyniku ≤4 w Teście Fagerströma sprawdzającym uzależnienie od nikotyny.","language":19,"languageDescription":"Polish"},{"id":12394161,"uuid":"930e348b-ea5b-40e8-bca2-b7ce17199415","attributeTranslation":"Μπορούν να απέχουν από τη χρήση νικοτίνης κατά τη συνεδρία χορήγησης δόσης (έως οκτώ ώρες), βάσει μιας βαθμολογίας ≤ 4 στο Fagerström Test for Nicotine Dependence (τεστ Fagerström για την εξάρτηση από τη νικοτίνη).","language":32,"languageDescription":"Greek (Greece)"}]},{"id":993468,"number":13,"principalInclusionCriteria":"Registered with a healthcare professional who can confirm the diagnosis and previous treatments received by the participant. Confirmation may be noted in the form of email, telephone contact, written report, or pharmacy records.","principalInclusionCriteriaTranslations":[{"id":12394164,"uuid":"cf30fc72-866c-4d48-891c-49e3c5c863c8","attributeTranslation":"Είναι καταγεγραμμένοι σε επαγγελματία υγείας που μπορεί να επιβεβαιώσει τη διάγνωση και τις προηγούμενες θεραπείες που έχουν λάβει. Η επιβεβαίωση ενδέχεται να γίνει μέσω email, τηλεφωνικής επικοινωνίας, γραπτής αναφοράς ή αρχείων φαρμακείου","language":32,"languageDescription":"Greek (Greece)"},{"id":12394163,"uuid":"cf30fc72-866c-4d48-891c-49e3c5c863c8","attributeTranslation":"Uczestnik musi być zarejestrowany przez pracownika służby zdrowia, który jest w stanie potwierdzić diagnozę i wcześniejsze metody leczenia stosowane przez uczestnika. Potwierdzenie może zostać dokonane w formie wiadomości e-mail, kontaktu telefonicznego, pisemnego raportu lub dokumentacji farmaceutycznej.","language":19,"languageDescription":"Polish"}]},{"id":993469,"number":14,"principalInclusionCriteria":"For Czech Republic only: The subject must have a designated caregiver who will accompany the participant to trial visits on Day 1 and Day 22 and escort the participant home after trial medication administration. The caregiver must be available throughout the trial to report on the participant’s symptoms or any worsening, maintain personal contact with the participant at least 3 days per week, and be willing to provide informed consent.","principalInclusionCriteriaTranslations":[]},{"id":993470,"number":2,"principalInclusionCriteria":"Male participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial starting at Screening (from signing of informed consent) and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential (POCBP).","principalInclusionCriteriaTranslations":[{"id":12394166,"uuid":"fe0cdd4b-46c6-43eb-8c13-d07a6b090832","attributeTranslation":"Uczestnicy zdolni do wytwarzania nasienia muszą stosować prezerwatywę ze środkiem plemnikobójczym (jeśli publicznie dostępne) w trakcie badania oraz przez 12 tygodni po przyjęciu przez nich ostatniej dawki badanego leku, jeśli ich partnerka jest w wieku rozrodczym.","language":19,"languageDescription":"Polish"},{"id":12394165,"uuid":"fe0cdd4b-46c6-43eb-8c13-d07a6b090832","attributeTranslation":"10.\tΟι συμμετέχοντες που είναι ικανοί να παράγουν σπέρμα πρέπει να χρησιμοποιούν προφυλακτικό και σπερματοκτόνο (όπου είναι διαθέσιμο στο κοινό) κατά τη διάρκεια της δοκιμής και για 12 εβδομάδες μετά την τελευταία δόση του φαρμάκου δοκιμής, εάν η σύντροφός τους είναι άτομο με αναπαραγωγική ικανότητα.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":993471,"number":3,"principalInclusionCriteria":"Female participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly [see Appendix 14.1]) during the trial, starting at Screening (from signing of informed consent), and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.","principalInclusionCriteriaTranslations":[{"id":12394167,"uuid":"88beff9a-a67f-4df9-905b-6b66f2e55123","attributeTranslation":"11.\tΟι συμμετέχουσες με αναπαραγωγική ικανότητα που έχουν σύντροφο ικανό να παράγει σπέρμα πρέπει να συμφωνήσουν να χρησιμοποιήσουν μια μέθοδο αντισύλληψης υψηλής αποτελεσματικότητας [δηλαδή, με ποσοστό αποτυχίας μικρότερο του 1%, όταν χρησιμοποιείται με συνέπεια και σωστά (βλ. Παράρτημα 14.1)] κατά τη διάρκεια της δοκιμής και για 12 εβδομάδες μετά την τελευταία δόση του φαρμάκου της δοκιμής. Οι εν λόγω συμμετέχουσες πρέπει να έχουν αρνητικό τεστ εγκυμοσύνης κατά τη διαλογή και την ημέρα –1 πριν από τη χορήγηση δόσης.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394168,"uuid":"88beff9a-a67f-4df9-905b-6b66f2e55123","attributeTranslation":"Uczestniczki w wieku rozrodczym, których partnerzy są zdolni wytwarzać nasienie, muszą wyrazić zgodę na stosowanie wysoce skutecznej metody antykoncepcji (tj. o wskaźniku niepowodzeń poniżej 1% przy konsekwentnym i prawidłowym stosowaniu [patrz załącznik 14.1]) podczas badania oraz przez 12 tygodni po przyjęciu ostatniej dawki badanego leku. Uczestniczki muszą mieć negatywny wynik testu ciążowego wykonanego podczas badania przesiewowego oraz w dniu -1. przed podaniem dawki.","language":19,"languageDescription":"Polish"}]},{"id":993472,"number":4,"principalInclusionCriteria":"Female participants who were capable of producing eggs (ova), must agree that the only exclusion from the requirement for contraception during the trial is to be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Tubal ligation does not count as permanent sterilization. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle-stimulating hormone level in the menopausal range (refer to ACM Lab Ranges), unless the participant is taking hormone replacement therapy or is using hormonal contraception.","principalInclusionCriteriaTranslations":[{"id":12394169,"uuid":"77bb508e-92a3-416e-b627-ec804d013ed4","attributeTranslation":"Οι συμμετέχουσες που ήταν ικανές να παράγουν ωάρια πρέπει να συμφωνήσουν ότι η μόνη εξαίρεση από την απαίτηση για αντισύλληψη κατά τη διάρκεια της δοκιμής είναι να είναι μετεμμηνοπαυσιακές ή μόνιμα στείρες κατόπιν υστερεκτομής, αμφοτερόπλευρης σαλπιγγεκτομής ή αμφοτερόπλευρης ωοθηκεκτομής. Ως μετεμμηνοπαυσιακή ορίζεται η φυσική αμηνόρροια για τουλάχιστον 12 μήνες και το επίπεδο ωοθυλακιοτρόπου ορμόνης στον ορό εντός του εύρους της εμμηνόπαυσης (σύμφωνα με τα φυσιολογικά όρια των εργαστηρίων ACM), εκτός αν η συμμετέχουσα λαμβάνει θεραπεία ορμονικής υποκατάστασης ή χρησιμοποιεί ορμονική αντισύλληψη.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394170,"uuid":"77bb508e-92a3-416e-b627-ec804d013ed4","attributeTranslation":"Uczestniczki zdolne do produkcji komórek jajowych (jajeczek) zgadzają się, że jedynym wyłączeniem z wymogu stosowania antykoncepcji podczas badania jest stan pomenopauzalny lub trwała bezpłodność po histerektomii, obustronnej salpingektomii lub obustronnym wycięciem jajników. Okres pomenopauzalny definiuje się jako spontaniczny brak miesiączki przez co najmniej 12 miesięcy oraz poziom hormonu folikulotropowego w surowicy w zakresie menopauzalnym (patrz zakresy laboratoryjne ACM), chyba że uczestniczka stosuje hormonalną terapię zastępczą lub antykoncepcję hormonalną.","language":19,"languageDescription":"Polish"}]},{"id":993473,"number":5,"principalInclusionCriteria":"Participant has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.","principalInclusionCriteriaTranslations":[{"id":12394171,"uuid":"73493297-5f7f-4867-b3d6-a4e3517b331c","attributeTranslation":"Έχουν παράσχει γραπτή συναίνεση κατόπιν ενημέρωσης, η οποία περιλαμβάνει τη συμμόρφωση με τις απαιτήσεις και τους περιορισμούς που αναφέρονται στο έντυπο συναίνεσης κατόπιν ενημέρωσης","language":32,"languageDescription":"Greek (Greece)"},{"id":12394172,"uuid":"73493297-5f7f-4867-b3d6-a4e3517b331c","attributeTranslation":"Uczestnik udzielił pisemnej świadomej zgody, co obejmuje przestrzeganie wymagań i ograniczeń wymienionych w formularzu świadomej zgody.","language":19,"languageDescription":"Polish"}]},{"id":993474,"number":6,"principalInclusionCriteria":"Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5-TR [if single episode, duration of ≥4 weeks and ≤24 months] and established as per evaluation by the Investigator that includes confirmation with the Mini  International Neuropsychiatric Interview [MINI, Version 7.0.2]). The first MDD episode must have occurred prior to age 60 by participant report or preferably medical records when available.","principalInclusionCriteriaTranslations":[{"id":12394174,"uuid":"d08b231c-e151-487a-abe5-e1756969c2ea","attributeTranslation":"2.\tΈχουν διάγνωση ΜΚΔ [μονήρους επεισοδίου ή υποτροπιάζουσας, όπως αυτά ορίζονται στο DSM-5-TR (σε περίπτωση μονήρους επεισοδίου, διάρκεια ≥ 4 εβδομάδων και ≤ 24 μηνών), το οποίο έχει διαπιστωθεί σύμφωνα με αξιολόγηση του ερευνητή που περιλαμβάνει επιβεβαίωση βάσει της Mini International Neuropsychiatric Interview (μίνι διεθνής νευροψυχιατρική συνέντευξη / MINI, έκδοση 7.0.2)]. Το πρώτο επεισόδιο ΜΚΔ πρέπει να έχει συμβεί πριν από την ηλικία των 60 ετών σύμφωνα με αναφορά του συμμετέχοντος ή, κατά προτίμηση, με τον ιατρικό φάκελο, αν είναι διαθέσιμο.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394173,"uuid":"d08b231c-e151-487a-abe5-e1756969c2ea","attributeTranslation":"U uczestnika zdiagnozowano MDD (pojedynczy lub nawracający epizod zgodnie z definicją DSM-5-TR [jeśli pojedynczy epizod, trwający ≥4 tygodnie i ≤24 miesiące] i ustalony na podstawie oceny badacza, która obejmuje potwierdzenie za pomocą ankiety Mini-International Neuropsychiatric Interview [MINI, wersja 7.0.2]). Pierwszy epizod (MDD) musiał wystąpić przed ukończeniem 60. roku życia, zgodnie ze zgłoszeniem uczestnika lub, najlepiej, z dokumentacją medyczną, jeśli jest dostępna.","language":19,"languageDescription":"Polish"}]},{"id":993475,"number":7,"principalInclusionCriteria":"Depression is of moderate to severe degree as indicated by a score of ≥24 on the MADRS and a score ≥4 on the Clinical Global Impressions-Severity at Screening and Baseline. The Screening MADRS assessment will be conducted by the Massachusetts General Hospital Clinical Trials Network and Institute SAFER (State versus trait; Assessability; Face validity; Ecological validity; and Rule of Three Ps [pervasive, persistent, and pathological]). The Baseline MADRS assessment will be performed by the Clinical Assessment Technologies Central MADRS Rater.","principalInclusionCriteriaTranslations":[{"id":12394175,"uuid":"7f7351d5-3579-4e2d-a0f3-34c9f82d08cd","attributeTranslation":"Depresja ma nasilenie umiarkowane do ciężkiego, co potwierdza wynik ≥24 w skali MADRS podczas badania przesiewowego, niezależnie potwierdzony przez Massachusetts General Hospital Clinical Trials Network i Institute SAFER (ocena cechy wobec stanu; ocena możliwości oceny; ocena trafności pozornej; ocena trafności ekologicznej; oraz zasada trzech P [wszechobecność, trwałość i patologia]) oraz wynik ≥4 w skali Clinical Global Impressions-Severity.","language":19,"languageDescription":"Polish"},{"id":12394176,"uuid":"7f7351d5-3579-4e2d-a0f3-34c9f82d08cd","attributeTranslation":"3. Η κατάθλιψη είναι μέτριας έως βαριάς μορφής, όπως υποδεικνύεται από μια βαθμολογία ≥ 24 στο MADRS και από μια βαθμολογία ≥4 στην κλίμακα Clinical Global Impressions Severity κατά τη διαλογή και την έναρξη. Η αξιολόγηση \nMADRS κατά τη διαλογή θα διεξάγεται από το SAFER [State versus trait, Assessability, Face validity, Ecological validity, Rule of Three Ps / κατάσταση έναντι χαρακτηριστικού, αξιολογησιμότητα, φαινομενική εγκυρότητα, οικολογική εγκυρότητα, κανόνας των τριών P (pervasive, persistent, pathological / διάχυτη, επίμονη, παθολογική)] του Massachusetts General Hospital Clinical Trials Network and Institute (Δίκτυο και Ινστιτούτο Κλινικών Δοκιμών του Γενικού Νοσοκομείου της Μασαχουσέτης). Η αξιολόγηση MADRS κατά την έναρξη θα διεξάγεται από τον κεντρικό βαθμολογητή MADRS του τμήματος τεχνολογιών κλινικής αξιολόγησης.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":993476,"number":8,"principalInclusionCriteria":"Participant has no more than a 25% decrease in the total MADRS score between Screening and the Baseline Visit (Day  -4 to -1).","principalInclusionCriteriaTranslations":[{"id":12394177,"uuid":"5111cfc0-158a-4491-bff5-0db1653873db","attributeTranslation":"Δεν έχουν μείωση άνω του 25% στη συνολική βαθμολογία MADRS μεταξύ διαλογής και επίσκεψης έναρξης (ημέρα -4 έως –1).","language":32,"languageDescription":"Greek (Greece)"},{"id":12394178,"uuid":"5111cfc0-158a-4491-bff5-0db1653873db","attributeTranslation":"U uczestnika całkowity wynik w skali MADRS pomiędzy wizytą przesiewową a wizytą wyjściową (dzień -1) uczestnika nie zmniejszył się o więcej niż 25%.","language":19,"languageDescription":"Polish"}]},{"id":993477,"number":9,"principalInclusionCriteria":"Participant has been on a stable and adequate (label specified) dose of a single antidepressant medication in the last month prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.","principalInclusionCriteriaTranslations":[{"id":12394180,"uuid":"1fbe6e93-814e-4ad3-a5d5-d5d6c44d7fc8","attributeTranslation":"Έχουν λάβει σταθερή και επαρκή δόση (ορίζεται στην επισήμανση) ενός μόνο αντικαταθλιπτικού φαρμάκου  τον \nτελευταίο μήνα πριν από τη διαλογή, και είχαν ανεπαρκή ανταπόκριση (βελτίωση κάτω του 50%), όπως κρίθηκε από τον ερευνητή.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394179,"uuid":"1fbe6e93-814e-4ad3-a5d5-d5d6c44d7fc8","attributeTranslation":"Uczestnik przyjmował stałą dawkę leków przeciwdepresyjnych (patrz punkt 6.2.3.1 dotyczący dozwolonych leków przeciwdepresyjnych i punkt 6.2.2 dotyczący leków zabronionych) w odpowiedniej dawce (określonej na etykiecie) przez odpowiedni okres w okresie ostatnich 4 tygodni poprzedzających badanie przesiewowe i nie zaobserwował u siebie wystarczającej odpowiedzi (poprawa o mniej niż 50%), zgodnie z oceną badacza i wywiadem SAFER.","language":19,"languageDescription":"Polish"}]}],"principalExclusionCriteria":[{"id":1695870,"number":1,"principalExclusionCriteria":"Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder (as determined by MINI with Borderline Personality Disorder Module Version 7.0.2 at Screening).","principalExclusionCriteriaTranslations":[{"id":12394088,"uuid":"f7c03335-c977-4f34-8289-c93288fd0645","attributeTranslation":"1.\tObecna lub wcześniej rozpoznana schizofrenia lub inne zaburzenia psychotyczne, w tym schizofrenia, zaburzenia schizoafektywne, zaburzenia schizotypowe, zaburzenia schizofrenopodobne, krótkotrwałe zaburzenia psychotyczne, zaburzenia nadpobudliwości psychoruchowej z deficytem uwagi, obecne lub wcześniejsze w wywiadzie zaburzenia afektywne dwubiegunowe lub obecne zaburzenia osobowości typu borderline (zgodnie z diagnozą MINI z modułem zaburzeń osobowości typu borderline w wersji 7.0.2 podczas badania przesiewowego).","language":19,"languageDescription":"Polish"},{"id":12394087,"uuid":"f7c03335-c977-4f34-8289-c93288fd0645","attributeTranslation":"Τρέχουσα ή παλαιότερη διάγνωση σχιζοφρενικών ή άλλων ψυχωτικών διαταραχών, όπως σχιζοφρένεια, \nσχιζοσυναισθηματική διαταραχή, σχιζότυπη διαταραχή, σχιζοφρενικόμορφη διαταραχή, βραχεία ψυχωτική διαταραχή, \nτρέχον ή προηγούμενο ιστορικό διπολικής διαταραχής ή τρέχουσας μεταιχμιακής διαταραχής προσωπικότητας (που έχει προσδιοριστεί με βάση το MINI, ενότητα μεταιχμιακής διαταραχής προσωπικότητας, έκδοση 7.0.2, κατά τη διαλογή).","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695871,"number":10,"principalExclusionCriteria":"Clinically relevant history of abnormal physical health interfering with the trial as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal [including dyspepsia or gastroesophageal reflux disease], hepatic or renal disorder).","principalExclusionCriteriaTranslations":[{"id":12394090,"uuid":"d7e97cb7-5574-4a79-b07a-3a6eca45b1ad","attributeTranslation":"Κλινικά συναφής μη φυσιολογική σωματική υγεία που επηρεάζει τη δοκιμή, όπως προσδιορίζεται από το ιατρικό ιστορικό και τις κλινικές εξετάσεις που πραγματοποιούνται κατά τη διαλογή και κατά την κρίση του ερευνητή [για παράδειγμα, νευρολογική, καρδιαγγειακή, αναπνευστική, γαστρεντερική (όπως δυσπεψία ή γαστροοισοφαγική παλινδρόμηση), ηπατική ή νεφρική διαταραχή].","language":32,"languageDescription":"Greek (Greece)"},{"id":12394089,"uuid":"d7e97cb7-5574-4a79-b07a-3a6eca45b1ad","attributeTranslation":"10.\tW wywiadzie klinicznie istotny nieprawidłowy stan zdrowia fizycznego wpływający negatywnie na badanie, określony na podstawie wywiadu medycznego i badań przedmiotowych przeprowadzonych podczas badań przesiewowych, zgodnie z oceną badacza (w tym między innymi zaburzenia neurologiczne, sercowo-naczyniowe, oddechowe, żołądkowo-jelitowe [w tym dyspepsja lub refluks żołądkowo-przełykowy], zaburzenia czynności wątroby lub nerek).","language":19,"languageDescription":"Polish"}]},{"id":1695872,"number":11,"principalExclusionCriteria":"Participants with renal insufficiency (estimated glomerular filtration rate ≤59 mL/min/1.73 m2).","principalExclusionCriteriaTranslations":[{"id":12394092,"uuid":"945cda27-fdb8-40c3-8a41-2890c6bc370d","attributeTranslation":"11.\tUczestnicy z niewydolnością nerek (szacowany współczynnik filtracji kłębuszkowej ≤59 ml/min/1,73 m2).","language":19,"languageDescription":"Polish"},{"id":12394091,"uuid":"945cda27-fdb8-40c3-8a41-2890c6bc370d","attributeTranslation":"Νεφρική ανεπάρκεια (εκτιμώμενος ρυθμός σπειραματικής διήθησης ≤ 59 ml/min/1,73 m2).","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695873,"number":12,"principalExclusionCriteria":"a) Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication, or b) Screening laboratory results of thyroid-stimulating hormone (TSH) <0.75 × the lower limit of normal or ≥1.25 × upper limit of normal (ULN), AND clinical signs/symptoms of thyroid disease, AND abnormal free triiodothyronine (T3) and free thyroxine (T4).","principalExclusionCriteriaTranslations":[{"id":12394093,"uuid":"55bcbf30-d90f-4cde-9d68-e0bfab7f0909","attributeTranslation":"12.\ta) Uczestnik cierpi na niedoczynność lub nadczynność tarczycy, chyba że jest to kontrolowane odpowiednimi lekami albo b) poziom hormonu tyreotropowego (TSH) podczas badania przesiewowego <0,75 × dolna granica normy albo ≥1,25 × górna granica normy (GGN) ORAZ objawy przedmiotowe i podmiotowe choroby tarczycy ORAZ nieprawidłowe stężenie wolnej trójjodotyroniny (T3) i wolnej tyroksyny (T4).12.\ta) Uczestnik cierpi na niedoczynność lub nadczynność tarczycy, chyba że jest to kontrolowane odpowiednimi lekami albo b) poziom hormonu tyreotropowego (TSH) podczas badania przesiewowego <0,75 × dolna granica normy albo ≥1,25 × górna granica normy (GGN) ORAZ objawy przedmiotowe i podmiotowe choroby tarczycy ORAZ nieprawidłowe stężenie wolnej trójjodotyroniny (T3) i wolnej tyroksyny (T4).","language":19,"languageDescription":"Polish"},{"id":12394094,"uuid":"55bcbf30-d90f-4cde-9d68-e0bfab7f0909","attributeTranslation":"α)Yποθυρεοειδισμός ή υπερθυρεοειδισμός, εκτός αν αυτός ελέγχεται με κατάλληλη φαρμακευτική αγωγή ή β)  αποτελέσματα εργαστηριακού ελέγχου κατά τη διαλογή για θυρεοειδοτρόπο ορμόνη (TSH) < 0,75 × το κατώτατο φυσιολογικό όριο ή ≥1,25 × ανώτατο φυσιολογικό όριο (ΑΦΟ) ΚΑΙ κλινικά σημεία/συμπτώματα θυρεοειδικής νόσου ΚΑΙ μη φυσιολογική ελεύθερη τριιωδοθυρονίνη (Τ3) και ελεύθερη θυροξίνη (Τ4).","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695874,"number":13,"principalExclusionCriteria":"Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically abnormal results for average heart rate (HR) (resting supine HR >100 beats per minute) or average blood pressure (BP) (resting supine systolic BP >139 mmHg or diastolic BP >89 mmHg) at Screening following triplicate readings; or if a particular reading (regardless of the average) is of clinical concern, in the judgement of the Investigator. Participants with well-controlled hypertension and who have been on a stable dose/doses of either 1 or 2 allowable antihypertensive medications for ≥4 weeks prior to Screening are permitted.","principalExclusionCriteriaTranslations":[{"id":12394095,"uuid":"1d79d23b-74ee-46f8-ab4b-baa875452eda","attributeTranslation":"13.\tUczestnicy z obecną diagnozą niekontrolowanego nadciśnienia lub arytmii serca lub klinicznie nieprawidłowymi wynikami badania średniej częstości akcji serca (HR) (częstość akcji serca w spoczynku w pozycji leżącej >100 uderzeń na minutę lub średnie ciśnienie krwi (ciśnienie skurczowe w spoczynku w pozycji leżącej >139 mmHg lub rozkurczowe >89 mmHg) podczas badania przesiewowego po uzyskaniu trzech odczytów; lub jeśli konkretny odczyt (niezależnie od średniej) budzi obawy kliniczne w ocenie badacza. Do badania mogą zostać zakwalifikowane osoby z dobrze kontrolowanym nadciśnieniem, które przez co najmniej 4 tygodnie przed badaniem przesiewowym przyjmowały stabilną dawkę/dawki 1 lub 2 dopuszczalnych leków przeciw nad ciśnieniowych.","language":19,"languageDescription":"Polish"},{"id":12394096,"uuid":"1d79d23b-74ee-46f8-ab4b-baa875452eda","attributeTranslation":"Τρέχουσα διάγνωση αρρύθμιστης υπέρτασης/αρρυθμίας ή κλινικώς μη φυσιολογικά αποτελέσματα μέσου καρδιακού ρυθμού (ΚΡ) (ΚΡ ηρεμίας σε ύπτια θέση > 100 παλμών ανά λεπτό) ή μέσης αρτηριακής πίεσης (ΑΠ) (συστολικής ΑΠ ηρεμίας σε ύπτια θέση > 139 mmHg ή διαστολικής ΑΠ >89 mmHg) κατά τη διαλογή μετά από τριπλές μετρήσεις ή εάν μια συγκεκριμένη μέτρηση (ανεξαρτήτως μέσου όρου) εγείρει κλινική ανησυχία, κατά την κρίση του Ερευνητή. Επιτρέπονται οι συμμετέχοντες μεεπαρκώςρυθμισμένη υπέρταση οι οποίοι έχουν λάβει σταθερή/-ές δόση/δόσεις είτε ενός είτε δύο επιτρεπόμενων αντιυπερτασικών φαρμάκων για ≥ 4 εβδομάδες πριν από τη διαλογή.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695875,"number":14,"principalExclusionCriteria":"Average QT interval corrected for heart rate using Fridericia’s formula >450 msec for males and >470 msec for females at Screening, following triplicate electrocardiogram (ECG) readings; or if a particular reading (regardless of the average) is of clinical concern, in the judgement of the Investigator.","principalExclusionCriteriaTranslations":[{"id":12394098,"uuid":"894dbf9a-75a0-40ae-a682-119cf86c085b","attributeTranslation":"14.\tŚredni odstęp QT skorygowany o częstość akcji serca według wzoru Fridericia > 450 ms dla mężczyzn i >470 ms dla kobiet podczas badań przesiewowych, po trzykrotnym wykonaniu badań elektrokardiograficznych (EKG); lub jeśli konkretny odczyt (niezależnie od średniej) budzi obawy kliniczne w ocenie badacza.","language":19,"languageDescription":"Polish"},{"id":12394097,"uuid":"894dbf9a-75a0-40ae-a682-119cf86c085b","attributeTranslation":"Μέσο διάστημα QT διορθωμένο ως προς τον καρδιακό ρυθμό με τον τύπο Fridericia > 450 msec για άνδρες και > 470 msec για γυναίκες κατά τη διαλογή, μετά από τριπλή ηλεκτροκαρδιογραφική μέτρηση ή εάν μια συγκεκριμένη μέτρηση (ανεξαρτήτως μέσου όρου) εγείρει κλινική ανησυχία, κατά την κρίση του Ερευνητή .","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695876,"number":15,"principalExclusionCriteria":"Presence of clinically significant ECG abnormalities at the Screening Visit, as defined by Investigator judgement.","principalExclusionCriteriaTranslations":[{"id":12394099,"uuid":"215cccf6-627d-476b-b4cd-8eebb36e5bd7","attributeTranslation":"15.\tObecność klinicznie istotnych nieprawidłowości w badaniu EKG podczas wizyty przesiewowej, zgodnie z oceną badacza.","language":19,"languageDescription":"Polish"},{"id":12394100,"uuid":"215cccf6-627d-476b-b4cd-8eebb36e5bd7","attributeTranslation":"Παρουσία κλινικά σημαντικών διαταραχών ΗΚΓ κατά την επίσκεψη διαλογής, κατά την κρίση του ερευνητή.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695877,"number":16,"principalExclusionCriteria":"History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the trial medication.","principalExclusionCriteriaTranslations":[{"id":12394101,"uuid":"78c741b0-cfb0-4cf4-aec1-2c4d68b3011c","attributeTranslation":"Ιστορικό ή κλινική τεκμηρίωση οποιασδήποτε νόσου και/ή ύπαρξη οποιασδήποτε χειρουργικής ή ιατρικής πάθησης που ενδέχεται να επηρεάσει την απορρόφηση, την κατανομή, τον μεταβολισμό ή την απέκκριση του φαρμάκου της δοκιμής.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394102,"uuid":"78c741b0-cfb0-4cf4-aec1-2c4d68b3011c","attributeTranslation":"16.\tW wywiadzie lub kliniczne objawy jakiejkolwiek choroby i/lub występowanie jakiegokolwiek stanu chirurgicznego lub medycznego, który mógłby wpływać na wchłanianie, dystrybucję, metabolizm lub wydalanie badanego leku.","language":19,"languageDescription":"Polish"}]},{"id":1695878,"number":17,"principalExclusionCriteria":"Participant has a presence or relevant history of organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).","principalExclusionCriteriaTranslations":[{"id":12394104,"uuid":"0fc2c376-3de7-4cb9-8dcd-125c5fdbb182","attributeTranslation":"17.\tUczestnik ma obecne lub przebyte zaburzenia organiczne mózgu (np. padaczkę, drgawki, nadciśnienie śródczaszkowe, krwotok śródczaszkowy i tętniaki, guz mózgu lub inne schorzenia związane z drgawkami lub konwulsjami).","language":19,"languageDescription":"Polish"},{"id":12394103,"uuid":"0fc2c376-3de7-4cb9-8dcd-125c5fdbb182","attributeTranslation":"Παρουσία ή συναφές ιστορικό οργανικών εγκεφαλικών διαταραχών (π.χ. επιληψίας, επιληπτικών κρίσεων, ενδοκράνιας υπέρτασης, ενδοκράνιας αιμορραγίας και ανευρυσματικής νόσου, όγκου στον εγκέφαλο ή άλλων ιατρικών παθήσεων που σχετίζονται με επιληπτικές κρίσεις ή ακούσιους μυϊκούς σπασμούς).","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695879,"number":18,"principalExclusionCriteria":"Participants with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 × ULN and total bilirubin ≥2 × ULN at Screening. These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the participant may be included only if the Investigator considers that the previous finding will not introduce additional risk factors and will not interfere with interpretation of safety data.","principalExclusionCriteriaTranslations":[{"id":12394106,"uuid":"1f845f1e-a6a7-49f5-b3bd-4179628fd5a2","attributeTranslation":"Συμμετέχοντες με ασπαρτική αμινοτρανσφεράση, αμινοτρανσφεράση της αλανίνης (ALT)≥3 × ΑΦΟ και ολική χολερυθρίνη ≥ 2 × ΑΦΟ κατά τη διαλογή. Αυτές οι εργαστηριακές αξιολογήσεις ενδέχεται να επαναληφθούν μία φορά κατά την κρίση του ερευνητή. Εάν η επαναληπτική εξέταση είναι εντός του εύρους αναφοράς, ο συμμετέχων μπορεί να ενταχθεί μόνο εάν ο Ερευνητής θεωρήσει ότι το προηγούμενο εύρημα δεν θα εισαγάγει πρόσθετους παράγοντες κινδύνου και δεν θα παρεμποδίζει την ερμηνεία των δεδομένων ασφάλειας.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394105,"uuid":"1f845f1e-a6a7-49f5-b3bd-4179628fd5a2","attributeTranslation":"18.\tUczestnicy z poziomem aminotransferazy asparaginianowej (AST) lub aminotransferazy alaninowej (ALT) ≥3 × górna granica normy oraz bilirubiny całkowitej ≥2 × górna granica normy podczas badania przesiewowego. Według uznania badacza badania te mogą zostać powtórzone. Jeżeli wyniki powtórnego badania mieszczą się w zakresie referencyjnym, uczestnik może zostać włączony do badania tylko wtedy, gdy badacz uzna, że poprzednie wyniki nie wprowadzą dodatkowych czynników ryzyka i nie wpłyną na interpretację danych dotyczących bezpieczeństwa.","language":19,"languageDescription":"Polish"}]},{"id":1695880,"number":19,"principalExclusionCriteria":"Positive urine test for drugs of abuse or alcohol breath test at Screening or at Day 1 or Day 22 prior to dosing. A positive test for cannabinoids (e.g., marijuana) at Screening may not exclude a participant, if after discussion with and evaluation by the Investigator, the participant agrees not to use any marijuana or other cannabinoid products during the trial, and if allowed to participate, the participant must test negative for cannabinoids on Day 1 and Day 22.","principalExclusionCriteriaTranslations":[{"id":12394107,"uuid":"a7d6b499-5b94-476e-856d-c98eedfcaa15","attributeTranslation":"19.\tDodatni wynik testu na obecność narkotyków lub alkoholu w moczu podczas badania przesiewowego lub w dniu 1. lub 22. przed podaniem dawki. Dodatni wynik testu na obecność kannabinoidów (np. marihuany) podczas badań przesiewających nie musi wykluczać uczestnika, jeśli po rozmowie z badaczem i ocenie przez niego uczestnik wyrazi zgodę na niezażywanie marihuany ani innych produktów zawierających kannabinoidy podczas badania, a jeśli zostanie dopuszczony do udziału, musi uzyskać ujemny wynik testu na obecność kannabinoidów w dniu 1. i 22.","language":19,"languageDescription":"Polish"},{"id":12394108,"uuid":"a7d6b499-5b94-476e-856d-c98eedfcaa15","attributeTranslation":"Θετικό τεστ ούρων για κατάχρηση ουσιών ή θετικό αλκοτέστ αναπνοής κατά τη διαλογή, την ημέρα 1 ή την ημέρα 22 πριν από τη χορήγηση δόσης. Τυχόν θετικό τεστ για κανναβινοειδή (π.χ. μαριχουάνα) κατά τη διαλογή ενδέχεται να μην αποκλείσει συμμετέχοντα αν, μετά από συζήτηση και αξιολόγηση από τον ερευνητή, ο συμμετέχων συμφωνήσει να μην χρησιμοποιήσει μαριχουάνα ή άλλα κανναβινοειδή προϊόντα κατά τη διάρκεια της δοκιμής. Αν του επιτραπεί να συμμετάσχει, ο συμμετέχων πρέπει να έχει αρνητικό τεστ για κανναβινοειδή την ημέρα 1 και την ημέρα 22.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695881,"number":2,"principalExclusionCriteria":"Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.","principalExclusionCriteriaTranslations":[{"id":12394110,"uuid":"f0061c2f-e5d4-4c13-b30c-b01f4599f80d","attributeTranslation":"2.\tUczestnicy, u których rozpoznano zespół nadpobudliwości psychoruchowej z deficytem uwagi (ADHD), zostaną wykluczeni z badania, jeśli obecnie przyjmują leki na ADHD.","language":19,"languageDescription":"Polish"},{"id":12394109,"uuid":"f0061c2f-e5d4-4c13-b30c-b01f4599f80d","attributeTranslation":"Συμμετέχοντες με ιατρική διάγνωση διαταραχής ελλειμματικής προσοχής και υπερκινητικότητας (ADHD) θα αποκλείονται εάν λαμβάνουν επί του παρόντος φαρμακευτική αγωγή για ADHD.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695882,"number":20,"principalExclusionCriteria":"History of substance use disorder (excepting caffeine and tobacco-related disorders) within the last year, as assessed by a structured clinical interview (MINI, Version 7.0.2) or determined by self-report, or intake of ³21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before Screening and each scheduled visit until discharge from the trial site. One unit is equivalent to a 285 mL glass of full-strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.","principalExclusionCriteriaTranslations":[{"id":12394112,"uuid":"d3455109-32b9-4e6b-aca1-897ac2bef8d3","attributeTranslation":"20.\tW wywiadzie zaburzenia związane z używaniem substancji psychoaktywnych (z wyjątkiem zaburzeń związanych z kofeiną i tytoniem) w ciągu ostatniego roku, ocenione na podstawie ustrukturyzowanego wywiadu klinicznego (MINI, wersja 7.0.2) lub określone na podstawie samooceny, lub spożywanie 21 jednostek alkoholu tygodniowo oraz niemożność powstrzymania się od spożywania alkoholu przez 48 godzin przed badaniem przesiewowym i każdą zaplanowaną wizytą aż do wypisania z ośrodka badawczego. Jedna jednostka odpowiada 285 ml szklanki mocnego piwa lub 1 (30 ml) miarce mocnego alkoholu lub 1 szklance (100 ml) wina.","language":19,"languageDescription":"Polish"},{"id":12394111,"uuid":"d3455109-32b9-4e6b-aca1-897ac2bef8d3","attributeTranslation":"Ιστορικό διαταραχής χρήσης ουσιών (εκτός από διαταραχές που σχετίζονται με την καφεΐνη και το κάπνισμα) τον τελευταίο χρόνο, όπως προκύπτει από δομημένη κλινική συνέντευξη (MINI, έκδοση 7.0.2) ή προσδιορίζεται από αυτοαναφορά, ή λήψη ³ 21 μονάδων αλκοόλ την εβδομάδα και αδυναμία αποχής από τη κατανάλωση αλκοόλ για 48 ώρες πριν από τη διαλογή και πριν από κάθε προγραμματισμένη επίσκεψη έως την έξοδο από το κέντρο της δοκιμής. Μία μονάδα αλκοόλ ισοδυναμεί με ένα ποτήρι (285 ml) μπίρα πλήρους περιεκτικότητας, μία μεζούρα (30 ml) οινοπνευματώδους ποτού ή ένα ποτήρι (100 ml) κρασί.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695883,"number":21,"principalExclusionCriteria":"Known sensitivity to psilocin and/or any excipients present in the formulation.","principalExclusionCriteriaTranslations":[{"id":12394114,"uuid":"02a1ab9d-ec9a-4dec-afff-12e378e2dfb1","attributeTranslation":"21.\tZnana wrażliwość na psylocynę i/lub wszelkie substancje pomocnicze obecne w preparacie.","language":19,"languageDescription":"Polish"},{"id":12394113,"uuid":"02a1ab9d-ec9a-4dec-afff-12e378e2dfb1","attributeTranslation":"Γνωστή ευαισθησία στην ψιλοκίνη και/ή σε άλλα έκδοχα που υπάρχουν στο σκεύασμα.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695884,"number":22,"principalExclusionCriteria":"Use of a prescription medicine other than stable chronic dose of antidepressant medication(s) with the exception of those permitted during the trial (refer to Sections 6.2.3 and 6.2.3.1 of the protocol) or over-the-counter (OTC) medicines during 14 days before dosing. The Investigator and trial team may review medication on a case-by-case basis to determine if its use would compromise participants’ safety or interfere with trial procedures or data interpretation in discussion with the Medical Monitor and/or Sponsor.","principalExclusionCriteriaTranslations":[{"id":12394116,"uuid":"e642c7be-eb21-4b52-b162-b51fe87ae831","attributeTranslation":"22.\tStosowanie leków na receptę innych niż stabilna dawka leków przeciwdepresyjnych stosowanych w leczeniu przewlekłym, z wyjątkiem leków dozwolonych podczas badania (patrz punkty 6.2.3 i 6.2.3.1 protokołu) lub leków dostępnych bez recepty (OTC) w ciągu 14 dni przed podaniem dawki. Badacz i zespół badawczy mogą dokonać przeglądu leków w poszczególnych przypadkach, aby ustalić, czy ich stosowanie zagraża bezpieczeństwu uczestników lub zakłóca przebieg badania lub interpretację danych, po konsultacji z monitorującym badanie lekarzem i/lub sponsorem.","language":19,"languageDescription":"Polish"},{"id":12394115,"uuid":"e642c7be-eb21-4b52-b162-b51fe87ae831","attributeTranslation":"Χρήση συνταγογραφούμενου φαρμάκου εκτός της σταθερής χρόνιας δόσης αντικαταθλιπτικών φαρμάκων, με εξαίρεση όσων επιτρέπονται κατά τη διάρκεια της δοκιμής (ανατρέξτε στις ενότητες 6.2.3 και 6.2.3.1 του πρωτοκόλλου), ή μη συνταγογραφούμενων (ΜΣ) φαρμάκων εντός 14 ημερών πριν από τη χορήγηση δόσης. Ο ερευνητής και η ομάδα της δοκιμής ενδέχεται να ελέγξουν τα φάρμακα κατά περίπτωση, για να προσδιορίζουν αν η χρήση τους ενδέχεται να θέσει σε κίνδυνο την ασφάλεια των συμμετεχόντων ή να επηρέασει τις διαδικασίες της δοκιμής ή την ερμηνεία των δεδομένων, σε συνεννοήση με τον επόπτη γιατρό και/ή τον χορηγό.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695885,"number":23,"principalExclusionCriteria":"Participant is taking or has taken any drugs known to inhibit monoamine oxidase within 14 days prior to trial medication administration.","principalExclusionCriteriaTranslations":[{"id":12394117,"uuid":"4133656e-9c0f-4284-a798-24b35f9226fa","attributeTranslation":"Τρέχουσα ή προηγούμενη λήψη φαρμάκου που είναι γνωστό ότι αναστέλλει την μονοαμινοξειδάση εντός 14 ημερών πριν από τη χορήγηση του φαρμάκου της δοκιμής.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394118,"uuid":"4133656e-9c0f-4284-a798-24b35f9226fa","attributeTranslation":"23.\tUczestnik przyjmuje lub przyjmował jakiekolwiek leki hamujące monoaminooksydazę w ciągu 14 dni przed podaniem leku w ramach badania.","language":19,"languageDescription":"Polish"}]},{"id":1695886,"number":24,"principalExclusionCriteria":"Participant is taking or has taken OTC doses of 5 hydroxytryptophan (5-HTP) or St John’s Wort within 14 days prior to trial medication administration.","principalExclusionCriteriaTranslations":[{"id":12394120,"uuid":"e93d7c69-c451-4436-a01a-076764b8ef0b","attributeTranslation":"Τρέχουσα ή προηγούμενη λήψη φαρμάκου ΜΣ δόσεις 5 υδροξυτρυπτοφάνης (5-HTP) ή βαλσαμόχορτου εντός 14 ημερών πριν από τη χορήγηση του φαρμάκου της δοκιμής.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394119,"uuid":"e93d7c69-c451-4436-a01a-076764b8ef0b","attributeTranslation":"24.\tUczestnik przyjmuje lub przyjmował dostępne bez recepty dawki 5-hydroksytryptofanu \n(5-HTP) lub dziurawca w okresie 14 dni poprzedzającym podanie leku w ramach badania.","language":19,"languageDescription":"Polish"}]},{"id":1695887,"number":25,"principalExclusionCriteria":"Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the trial as outlined in this protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this trial.","principalExclusionCriteriaTranslations":[{"id":12394121,"uuid":"64fb968b-79a5-4c55-8583-eade7213a4b2","attributeTranslation":"Οποιοδήποτε άλλο συνοδό νόσημα ή πάθηση το οποίο ενδέχεται να επηρεάσει τη διεξαγωγή της δοκιμής, η θεραπεία του οποίου ενδέχεται να επηρεαστεί τη δοκιμή, όπως περιγράφεται στο παρόν πρωτόκολλο, ή το οποίο θα αποτελούσε, κατά τη γνώμη του ερευνητή, μη αποδεκτό κίνδυνο για τον συμμετέχοντα.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394122,"uuid":"64fb968b-79a5-4c55-8583-eade7213a4b2","attributeTranslation":"25.\tWszelkie inne współistniejące choroby lub stany, które mogą zakłócić przebieg badania zgodnie z niniejszym protokołem lub które mogą kolidować z leczeniem, lub które w opinii badacza stanowią niedopuszczalne ryzyko dla udziału uczestnika w badaniu.","language":19,"languageDescription":"Polish"}]},{"id":1695888,"number":26,"principalExclusionCriteria":"Other eligibility considerations (e.g., participant personal circumstances, behavior, and/or any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to psilocin), as judged by the Investigator.","principalExclusionCriteriaTranslations":[{"id":12394124,"uuid":"b40067ae-f392-49d8-bbd5-bbecc1639338","attributeTranslation":"26.\tInne kryteria kwalifikujące według oceny badacza (np. osobiste okoliczności uczestnika, zachowanie i/lub jakiekolwiek bieżące problemy, które mogłyby przeszkodzić w uczestnictwie lub które są nie do pogodzenia z nawiązaniem relacji lub bezpieczną ekspozycją na psylocynę).","language":19,"languageDescription":"Polish"},{"id":12394123,"uuid":"b40067ae-f392-49d8-bbd5-bbecc1639338","attributeTranslation":"Άλλοι παράγοντες επιλεξιμότητας (π.χ. προσωπικές περιστάσεις του συμμετέχοντος, συμπεριφορά συμμετέχοντος και/ή οποιοδήποτε τρέχον πρόβλημα που ενδέχεται να επηρεάσει τη συμμετοχή ή είναι ασύμβατο με την οικοδόμηση σχέσης εμπιστοσύνης ή με την ασφαλή έκθεση στην ψιλοκίνη), κατά την κρίση του ερευνητή.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695889,"number":27,"principalExclusionCriteria":"The participant has participated in a clinical trial and has received a medication or a new chemical entity within 12 weeks prior to dosing with the current trial medication. Participants who have completed observational or non-interventional trials will be allowed.","principalExclusionCriteriaTranslations":[{"id":12394126,"uuid":"93c6fa2a-0db5-42af-a79f-01edab9fe6db","attributeTranslation":"Προγενέστερη συμμετοχή σε κλινική δοκιμή και λήψη φαρμάκου ή νέας χημικής ουσίας/ένωσης εντός 12 εβδομάδων πριν από τη χορήγηση του φαρμάκου αυτής της δοκιμής. Η συμμετοχή ατόμων που έχουν ολοκληρώσει παρατηρητικές ή μη παρεμβατικές μελέτες επιτρέπεται.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394125,"uuid":"93c6fa2a-0db5-42af-a79f-01edab9fe6db","attributeTranslation":"27.\tUczestnik brał udział w badaniu klinicznym i otrzymał lek lub nową substancję chemiczną w ciągu 12 tygodni przed rozpoczęciem podawania obecnego leku badanego. Dopuszczone zostaną osoby, które ukończyły badania obserwacyjne lub nieinterwencyjne.","language":19,"languageDescription":"Polish"}]},{"id":1695890,"number":28,"principalExclusionCriteria":"Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.","principalExclusionCriteriaTranslations":[{"id":12394127,"uuid":"ccf7a88a-d439-4c05-baa1-386100bdd070","attributeTranslation":"28.\tUczestnicy zdolni do produkcji nasienia, którzy nie powstrzymają się od oddawania nasienia pomiędzy pierwszą dawką a 12 tygodniami po ostatniej dawce.","language":19,"languageDescription":"Polish"},{"id":12394128,"uuid":"ccf7a88a-d439-4c05-baa1-386100bdd070","attributeTranslation":"Σε περίπτωση ικανότητας παραγωγής σπέρματος, αδυναμία αποχής από τη δωρεά σπέρματος από τη χορήγηση της πρώτης δόσης και για 12 εβδομάδες μετά τη χορήγηση της τελευταίας.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695891,"number":29,"principalExclusionCriteria":"POCBP who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.","principalExclusionCriteriaTranslations":[{"id":12394129,"uuid":"75baccc2-57cf-4953-9373-acf781c6fef1","attributeTranslation":"29.\tUczestniczki w wieku rozrodczym, które są w ciąży, karmią piersią, planują ciążę lub nie chcą powstrzymać się od oddania komórek jajowych (jajeczek) w okresie od pierwszej dawki do 12 tygodni po ostatniej dawce.","language":19,"languageDescription":"Polish"},{"id":12394130,"uuid":"75baccc2-57cf-4953-9373-acf781c6fef1","attributeTranslation":"Σε περίπτωση POCBP, εγκυμοσύνη, θηλασμός, σχέδια για σύλληψη ή αδυναμία αποχής από τη δωρεά ωαρίων από τη χορήγηση της πρώτης δόσης και για 12 εβδομάδες μετά τη χορήγηση της τελευταίας.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695892,"number":3,"principalExclusionCriteria":"Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).","principalExclusionCriteriaTranslations":[{"id":12394131,"uuid":"462a22ba-59e5-4b52-8135-760a47c507db","attributeTranslation":"Οικογενειακό ιστορικό σχιζοφρένειας, σχιζοσυναισθηματικής διαταραχής ή διπολικής διαταραχής τύπου 1 (συγγενείς πρώτου βαθμού).","language":32,"languageDescription":"Greek (Greece)"},{"id":12394132,"uuid":"462a22ba-59e5-4b52-8135-760a47c507db","attributeTranslation":"3.\tSchizofrenia, zaburzenie schizoafektywne lub zaburzenia dwubiegunowe typu 1 w wywiadzie rodzinnym (krewni pierwszego stopnia).","language":19,"languageDescription":"Polish"}]},{"id":1695893,"number":30,"principalExclusionCriteria":"History of serotonin syndrome.","principalExclusionCriteriaTranslations":[{"id":12394134,"uuid":"ed3899e8-57b3-4b06-a118-3f8aca45d054","attributeTranslation":"Ιστορικό συνδρόμου σεροτονίνης.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394133,"uuid":"ed3899e8-57b3-4b06-a118-3f8aca45d054","attributeTranslation":"30.\tZespół serotoninowy w wywiadzie.","language":19,"languageDescription":"Polish"}]},{"id":1695894,"number":31,"principalExclusionCriteria":"Unwilling to consent to audio and video recording of psychological support and dosing sessions.","principalExclusionCriteriaTranslations":[{"id":12394136,"uuid":"77c0e062-c8b7-4ba8-bebe-2c94b7aef8f6","attributeTranslation":"31.\tBrak zgody na nagrywanie dźwięku i obrazu podczas sesji wsparcia psychologicznego i sesji podania dawki.","language":19,"languageDescription":"Polish"},{"id":12394135,"uuid":"77c0e062-c8b7-4ba8-bebe-2c94b7aef8f6","attributeTranslation":"Απροθυμία για συναίνεση στην ηχογράφηση και τη βιντεοσκόπηση των συνεδριών ψυχολογικής υποστήριξης και χορήγησης δόσης.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695895,"number":32,"principalExclusionCriteria":"Staff and family members of Cybin IRL Limited, Investigator sites, contact research organization, or other vendors.","principalExclusionCriteriaTranslations":[{"id":12394137,"uuid":"36c2c0e1-f34d-4d9c-bae4-577122379a7e","attributeTranslation":"Το προσωπικό της Cybin IRL Limited, των ερευνητικών κέντρων, του συμβεβλημένου ερευνητικού οργανισμού και άλλων προμηθευτών, καθώς και μέλη της οικογένειάς του.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394138,"uuid":"36c2c0e1-f34d-4d9c-bae4-577122379a7e","attributeTranslation":"32.\tPracownicy i członkowie rodzin firmy Cybin IRL Limited, ośrodków badawczych, organizacji prowadzących badania kliniczne na zlecenie lub innych dostawców.","language":19,"languageDescription":"Polish"}]},{"id":1695896,"number":4,"principalExclusionCriteria":"Significant suicide risk as defined by (a) suicidal ideation as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injurious behavior within 12 months of Screening.","principalExclusionCriteriaTranslations":[{"id":12394140,"uuid":"2df7a0d7-2a40-4618-9753-aaa17d99ea7b","attributeTranslation":"Σοβαρός κίνδυνος αυτοκτονίας που προσδιορίζεται από (α) αυτοκτονικό ιδεασμό, όπως αυτός επικυρώνεται από τις ερωτήσεις 4 ή 5 του C-SSRS, εντός των τελευταίων έξι μηνών, κατά τη διάρκεια της περιόδου διαλογής ή κατά την έναρξη, (β) αυτοκτονικές συμπεριφορές εντός 12 μηνών πριν από τη διαλογή, (γ) κλινική αξιολόγηση σοβαρού κινδύνου αυτοκτονίας κατά την κλινική συνέντευξη ή (δ) μη αυτοκτονική αυτοτραυματική συμπεριφορά εντός 12 μηνών πριν από τη διαλογή.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394139,"uuid":"2df7a0d7-2a40-4618-9753-aaa17d99ea7b","attributeTranslation":"4.\tZnaczne ryzyko samobójstwa zdefiniowane jako (a) myśli samobójcze potwierdzone w punktach 4 lub 5 skali Columbia-Suicide Severity Rating Scale w ciągu ostatnich 6 miesięcy, w okresie badania przesiewowego lub w momencie rozpoczęcia badania; lub (b) zachowania samobójcze w ciągu 12 miesięcy od badania przesiewowego; lub (c) kliniczna ocena znacznego ryzyka samobójczego podczas wywiadu klinicznego; lub (d) zachowania autodestrukcyjne bez intencji samobójczych w ciągu 12 miesięcy od badania przesiewowego.","language":19,"languageDescription":"Polish"}]},{"id":1695897,"number":5,"principalExclusionCriteria":"Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration of ≥6 weeks as judged by the Investigator and SAFER interview.","principalExclusionCriteriaTranslations":[{"id":12394141,"uuid":"9e2da08c-7043-4b1e-a3e2-d60b191c1e40","attributeTranslation":"Τρέχουσα ή παλαιότερη διάγνωση ΜΚΔ ανθεκτικής σε θεραπεία, που ορίζεται ως η αποτυχία ανταπόκρισης σε τουλάχιστον δύο θεραπείες με αντικαταθλιπτικά δύο διαφορετικών κατηγοριών που χορηγούνται σε επαρκή δόση (όπως ορίζεται στην επισήμανση) και για επαρκές χρονικό διάστημα ≥6 εβδομάδων, σύμφωνα με την κρίση του ερευνητή και τη συνέντευξη SAFER.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394142,"uuid":"9e2da08c-7043-4b1e-a3e2-d60b191c1e40","attributeTranslation":"5.\tUczestnik musi mieć obecną albo wcześniejszą diagnozę MDD opornej na leczenie, czyli brak reakcji na co najmniej 2 różne leki przeciwdepresyjne z 2 różnych grup, podawane w odpowiedniej dawce (zgodnie z zaleceniami producenta) przez odpowiedni czas wynoszący ≥6 tygodni, zgodnie z oceną badacza i wywiadem SAFER.","language":19,"languageDescription":"Polish"}]},{"id":1695898,"number":6,"principalExclusionCriteria":"Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.","principalExclusionCriteriaTranslations":[{"id":12394144,"uuid":"4ca34c08-6fb4-4d87-acc2-063ae7e95de2","attributeTranslation":"6.\tW ciągu ostatnich 6 miesięcy pacjenta poddano leczeniu elektrowstrząsowemu, przezczaszkowej stymulacji magnetycznej, głębokiej stymulacji mózgu lub stymulacji nerwu błędnego z powodu jakiegokolwiek epizodu dużego zaburzenia depresyjnego.","language":19,"languageDescription":"Polish"},{"id":12394143,"uuid":"4ca34c08-6fb4-4d87-acc2-063ae7e95de2","attributeTranslation":"Ηλεκτροσπασμοθεραπεία, διακρανιακή μαγνητική διέγερση, εν τω βάθει εγκεφαλική διέγερση ή διέγερση πνευμονογαστρικού νεύρου για οποιοδήποτε επεισόδιο ΜΚΔ τους τελευταίους έξι μήνες.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1695899,"number":7,"principalExclusionCriteria":"Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer for MDD. Note: If receiving these medications for another indication they must be discontinued ≥14 days or 5 half-lives, whichever is longer, prior to Day 1.","principalExclusionCriteriaTranslations":[{"id":12394146,"uuid":"dda33ba0-6089-468d-a478-091006f45785","attributeTranslation":"Τρέχουσα λήψη αναστολέα μονοαμινοξειδάσης, τρικυκλικό αντικαταθλιπτικό, μιρταζαπίνη, τραζοδόνη, μοκλοβεμίδη, βουσπιρόνη, αντιψυχωσικό ή σταθεροποιητή διάθεσης για τη ΜΚΔ.  \n\nΣημείωση: Εάν τα φάρμακα αυτά λαμβάνονται για άλλες \n\nενδείξεις, πρέπει να διακόπτονται ≥14 ημέρες ή για χρονικό διάστημα ίσο με 5 χρόνους ημίσειας ζωής, όποιο είναι μεγαλύτερο, πριν από την Ημέρα 1.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394145,"uuid":"dda33ba0-6089-468d-a478-091006f45785","attributeTranslation":"7.\tUczestnik przyjmuje obecnie inhibitor monoaminooksydazy, trójpierścieniowy lek przeciwdepresyjny, mirtazapinę, trazodon, moklobemid, buspiron, ketaminę lub S-ketaminę, lek przeciwpsychotyczny lub stabilizator nastroju w leczeniu MDD.\nUwaga: w przypadku przyjmowania tych leków z innego powodu należy je odstawić ≥14 dni przed rozpoczęciem badania lub po upływie 5 okresów półtrwania, w zależności od tego, który z tych okresów jest dłuższy","language":19,"languageDescription":"Polish"}]},{"id":1695900,"number":8,"principalExclusionCriteria":"Participant report of (or if available in medical record) exposure to psilocin or 5-hydroxyryptamine 2A (5HT2A) receptor agonists, or any other psychedelics, regardless of dose, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant’s lifetime, or any psychedelic use within 12 months prior to Screening. Note: Use of any psychedelic Microdose counts as a single psychedelic dose.","principalExclusionCriteriaTranslations":[{"id":12394147,"uuid":"6120e81f-f7ac-4ac1-902e-889990ca1fb4","attributeTranslation":"Αναφορά από τους ίδιους (ή ιατρικό ιστορικό) για έκθεση σε ψιλοκίνη, αγωνιστές υποδοχεών 5-υδροξυτρυπταμίνης 2Α (5HT2Α) ή οποιοδήποτε άλλο ψυχεδελικό, ανεξαρτήτως δόσης, όπως αγιαχουάσκα, μεσκαλίνη, διαιθυλαμίδιο του λυσεργικού οξέος (LSD), πεγιότ ή 3,4-μεθυλενοδιοξυμεθαμφεταμίνη, πάνω από δέκα φορές στη ζωή τους, ή για οποιαδήποτε χρήση ψυχεδελικών εντός 12 μηνών πριν από τη διαλογή.  \n\nΣημείωση: Η χρήση οποιασδήποτε μικροδόσης ψυχεδελικής ουσίας υπολογίζεται ως μία ψυχεδελική δόση.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394148,"uuid":"6120e81f-f7ac-4ac1-902e-889990ca1fb4","attributeTranslation":"8.\tZgłoszenie przez uczestnika (lub, jeśli jest dostępne w dokumentacji medycznej) narażenia na psylocynę lub agonistów receptora 5-hydroksytryptaminowego 2A (5HT-2a) lub inne substancje psychodeliczne, niezależnie od dawki, takie jak ayahuasca, meskalina, dietyloamid kwasu lizergowego, peyotl lub 3,4-metylenodioksymetamfetaminy, więcej niż 10 razy w ciągu życia uczestnika lub jakiekolwiek użycie substancji psychodelicznych w ciągu 12 miesięcy przed badaniem przesiewowym.","language":19,"languageDescription":"Polish"}]},{"id":1695901,"number":9,"principalExclusionCriteria":"Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.","principalExclusionCriteriaTranslations":[{"id":12394149,"uuid":"4f8c5e95-5015-46fc-9434-959c98d65e3a","attributeTranslation":"Αναφορά από τους ίδιους (ή ιατρικό ιστορικό) για θεραπεία με χρήση κεταμίνης ή εσκεταμίνης εντός 6 μηνών πριν από τη διαλογή.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394150,"uuid":"4f8c5e95-5015-46fc-9434-959c98d65e3a","attributeTranslation":"9.\tZgłoszenie przez uczestnika (lub, jeśli jest dostępne w dokumentacji medycznej) leczenia ketaminą lub S-ketaminą w ciągu 12 miesięcy przed badaniem przesiewowym.\n\nUwaga: przyjęcie jakiejkolwiek mikrodawki substancji psychodelicznej traktuje się jako jedną dawkę substancji psychodelicznej.","language":19,"languageDescription":"Polish"}]}]},"endPoint":{"primaryEndPoints":[{"id":1161380,"number":1,"endPoint":"Change from Baseline (Day -4 to -1) to Day 42 in MADRS total score.","isPrimary":true,"endPointTranslations":[{"id":12394066,"uuid":"ffc14d86-5ae3-4fc2-b4bd-a0b2f376cfae","attributeTranslation":"Μεταβολή στη συνολική βαθμολογία MADRS από την έναρξη (ημέρα -4 έως –1) έως την ημέρα  42","language":32,"languageDescription":"Greek (Greece)"},{"id":12394065,"uuid":"ffc14d86-5ae3-4fc2-b4bd-a0b2f376cfae","attributeTranslation":"Zmiana od punktu początkowego (od Dnia -4. do -1.) do Dnia 42. w całkowitym wyniku MADRS","language":19,"languageDescription":"Polish"}]}],"secondaryEndPoints":[{"id":1161381,"number":1,"endPoint":"Change from Baseline (Day -4 to -1) to Day 84 in MADRS total score.","isPrimary":false,"endPointTranslations":[{"id":12394068,"uuid":"f20aa479-fea4-4890-a75c-1637d27d24d8","attributeTranslation":"Zmiana od punktu początkowego (od Dnia -4. do -1.) do Dnia 84. w całkowitym wyniku MADRS","language":19,"languageDescription":"Polish"},{"id":12394067,"uuid":"f20aa479-fea4-4890-a75c-1637d27d24d8","attributeTranslation":"Μεταβολή στη συνολική βαθμολογία MADRS από την έναρξη (ημέρα -4 έως –1) έως την ημέρα  84","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1161382,"number":2,"endPoint":"Proportion of participants with response defined as a ≥50% decrease in MADRS total score from Baseline (Day -4 to -1) to Day 84. Response will also be assessed after each dosing session (Day 2 and Day 23) and through Day 84.","isPrimary":false,"endPointTranslations":[{"id":12394070,"uuid":"efd6c638-00c8-4286-9592-98bed1348930","attributeTranslation":"Αναλογία συμμετεχόντων με ανταπόκριση που ορίζεται ως μείωση  ≥ 50% της συνολικής βαθμολογίας MADRS από την έναρξη (ημέρα -4 έως –1) έως την ημέρα 84. Η ανταπόκριση θα αξιολογείται και μετά από κάθε συνεδρία χορήγησης δόσης (ημέρα 2 και ημέρα 23) έως την ημέρα  84.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394069,"uuid":"efd6c638-00c8-4286-9592-98bed1348930","attributeTranslation":"Odsetek uczestników, u których odpowiedź zdefiniowano jako ≥50% spadek całkowitego wyniku MADRS od wartości początkowej (od Dnia -4. do -1.) do Dnia 84. Odpowiedź będzie również oceniana po każdej sesji podania dawki (Dzień 2. i Dzień 23.) aż do Dnia 84.","language":19,"languageDescription":"Polish"}]},{"id":1161383,"number":3,"endPoint":"Proportion of participants in remission defined as MADRS total score ≤10 at Day 84. Remission will also be assessed after each dosing session (Day 2 and Day 23) and through Day 84.","isPrimary":false,"endPointTranslations":[{"id":12394071,"uuid":"1d00803c-90c5-46e3-b0de-a2007c532fd5","attributeTranslation":"Ποσοστό των συμμετεχόντων σε ύφεση που ορίζεται ως συνολική βαθμολογία MADRS ≤10 την Ημέρα 84. Η ύφεση θα αξιολογείται επίσης μετά από κάθε συνεδρία δοσολογίας (Ημέρα 2 και Ημέρα 23) και έως την Ημέρα 84.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394072,"uuid":"1d00803c-90c5-46e3-b0de-a2007c532fd5","attributeTranslation":"Odsetek uczestników, u których nastąpiła remisja, zdefiniowany jako całkowity wynik MADRS ≤10 w Dniu 84. Ocena remisji będzie przeprowadzana po każdej sesji podania dawki (Dzień 2. i Dzień 23.) aż do Dnia 84.","language":19,"languageDescription":"Polish"}]},{"id":1161384,"number":4,"endPoint":"Proportion of responders with a sustained response (sustained defined as those meeting response criteria on or before Day 42 and sustained through Day 84 with one score greater than that for the response criterion permitted).","isPrimary":false,"endPointTranslations":[{"id":12394074,"uuid":"82d8aa0d-e9f2-4450-9739-1cac2397c1ec","attributeTranslation":"Ποσοστό ανταποκρινόμενων με παρατεταμένη ανταπόκριση (παρατεταμένη ορίζεται η ανταπόκριση που πληροί τα κριτήρια ανταπόκρισης την Ημέρα 42 ή πριν από αυτή και η οποία διατηρείται μέχρι την Ημέρα 84 με βαθμολογία κατά ένα βαθμό παραπάνω από αυτή για το επιτρεπόμενο κριτήριο ανταπόκρισης).","language":32,"languageDescription":"Greek (Greece)"},{"id":12394073,"uuid":"82d8aa0d-e9f2-4450-9739-1cac2397c1ec","attributeTranslation":"Odsetek pacjentów, u których wystąpiła trwała odpowiedź (trwała odpowiedź definiowana jako odpowiedź spełniająca kryteria odpowiedzi do Dnia 42. włącznie i utrzymująca się do Dnia 84. z wynikiem o jeden większym od dopuszczalnego dla kryterium odpowiedzi).","language":19,"languageDescription":"Polish"}]},{"id":1161385,"number":5,"endPoint":"Proportion of participants with a sustained remission (sustained defined as those meeting remission criteria on or before Day 42 and sustained through Day 84 with one score greater than that for the remission criterion permitted).","isPrimary":false,"endPointTranslations":[{"id":12394076,"uuid":"4c0a2376-ec2d-43db-9b31-1e69f285ab28","attributeTranslation":"Odsetek uczestników, u których wystąpiła trwała remisja (trwała definiowana jako remisja spełniająca kryteria remisji do Dnia 42. włącznie i utrzymująca się do Dnia 84. z wynikiem o jeden większym od dopuszczalnego dla kryterium remisji).","language":19,"languageDescription":"Polish"},{"id":12394075,"uuid":"4c0a2376-ec2d-43db-9b31-1e69f285ab28","attributeTranslation":"Ποσοστό συμμετεχόντων με παρατεταμένη ύφεση (παρατεταμένη ορίζεται η ύφεση που πληροί τα κριτήρια ύφεσης την Ημέρα 42 ή πριν από αυτή και η οποία διατηρείται μέχρι την Ημέρα 84 με βαθμολογία κατά ένα βαθμό παραπάνω από αυτή για το επιτρεπόμενο κριτήριο ύφεσης).","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1161386,"number":6,"endPoint":"Change from Baseline to each timepoint assessed in BDI-II.","isPrimary":false,"endPointTranslations":[{"id":12394078,"uuid":"0e954bba-b8ad-4bd8-83c1-5d079cf4c396","attributeTranslation":"Zmiana od punktu początkowego do każdego punktu czasowego oceniana pod względem BDI-II.","language":19,"languageDescription":"Polish"},{"id":12394077,"uuid":"0e954bba-b8ad-4bd8-83c1-5d079cf4c396","attributeTranslation":"Αλλαγή από την αξιολόγηση αναφοράς έως κάθε χρονικό σημείο που αξιολογείται στο BDI-II.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1161387,"number":7,"endPoint":"Change from Baseline to each timepoint assessed in CGI-S score.","isPrimary":false,"endPointTranslations":[{"id":12394080,"uuid":"611fec72-d89f-44ae-9e83-ca5813e349bb","attributeTranslation":"Αλλαγή από την αξιολόγηση αναφοράς έως κάθε χρονικό σημείο που αξιολογείται στη βαθμολογία CGI-S.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394079,"uuid":"611fec72-d89f-44ae-9e83-ca5813e349bb","attributeTranslation":"Zmiana od punktu początkowego do każdego punktu czasowego oceniana pod względem punktacji CGI-S.","language":19,"languageDescription":"Polish"}]},{"id":1161388,"number":8,"endPoint":"CGI-I score at each timepoint to assess change since Baseline (Day -4 to -1).","isPrimary":false,"endPointTranslations":[{"id":12394082,"uuid":"eaa347a2-b862-41d6-b477-3d45d0e4a3a4","attributeTranslation":"Βαθμολογία CGI-I σε κάθε χρονικό σημείο για αξιολόγηση της μεταβολής από την έναρξη (ημέρα -4 έως –1).","language":32,"languageDescription":"Greek (Greece)"},{"id":12394081,"uuid":"eaa347a2-b862-41d6-b477-3d45d0e4a3a4","attributeTranslation":"Wynik CGI-I w każdym punkcie czasowym pozwala ocenić zmianę od wartości początkowej (od Dnia -4. do -1.).","language":19,"languageDescription":"Polish"}]},{"id":1161389,"number":9,"endPoint":"Change from Baseline to each timepoint assessed in GAD-7 total score.","isPrimary":false,"endPointTranslations":[{"id":12394084,"uuid":"033cdfc5-e5b2-4e79-b587-5b354452085f","attributeTranslation":"Zmiana od punktu początkowego do każdego punktu czasowego oceniana w całkowitym wyniku GAD-7.","language":19,"languageDescription":"Polish"},{"id":12394083,"uuid":"033cdfc5-e5b2-4e79-b587-5b354452085f","attributeTranslation":"Αλλαγή από την αξιολόγηση αναφοράς έως κάθε χρονικό σημείο που αξιολογείται στη συνολική βαθμολογία GAD-7.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1161390,"number":10,"endPoint":"Change from Baseline to each timepoint assessed in Q-LES-Q-SF total score.","isPrimary":false,"endPointTranslations":[{"id":12394085,"uuid":"ddc6e5b0-b51d-42e4-825f-71a21b7152da","attributeTranslation":"Αλλαγή από την αξιολόγηση αναφοράς έως κάθε χρονικό σημείο που αξιολογείται στη συνολική βαθμολογία Q-LES-Q-SF.","language":32,"languageDescription":"Greek (Greece)"},{"id":12394086,"uuid":"ddc6e5b0-b51d-42e4-825f-71a21b7152da","attributeTranslation":"Zmiana od wartości początkowej do każdego punktu czasowego oceniana w całkowitym wyniku Q-LES-Q-SF.","language":19,"languageDescription":"Polish"}]}]},"trialDuration":{"estimatedGlobalEndDate":"2027-06-30","estimatedEndDate":"2027-06-30","estimatedRecruitmentStartDate":"2025-08-01"},"sourceOfMonetarySupport":[{"id":107341,"organisationName":"Cybin IRL 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the 3 pre-dose sessions and eligibility re-confirmation by the Investigator prior to dosing. \n\nThe Treatment Period will last approximately 6 weeks and will consist of 2 administrations of 8 mg IP, 16 mg IP, or placebo (on Day 1 and Day 22). The duration of each treatment session will last approximately 8 hours, and participants will be discharged once the Investigator deems it is safe to do so (no sooner than 8 hours after dosing) following collection of post-dose assessments and meeting all discharge criteria (see Section 4.1 and Table 1.1).","blindingMethodCode":"2","blindedRoles":[{"id":206870,"code":1,"name":"Subject"},{"id":206871,"code":2,"name":"Investigator"},{"id":206872,"code":3,"name":"Monitor"}],"blindingDetails":"The trial medication will be provided in blinded treatment kits, uniquely numbered by an IRT system. The IP and placebo will have the same visual appearance in order to avoid compromising trial blinding. Each kit will be labelled by the IRT system with a unique kit number; labelling will not indicate whether the trial medication is the IP or placebo.\nThe IP and placebo will be administered in the same manner to maintain blinding of the treatment allocation.","armDetails":[{"description":"The Treatment Period will last approximately 6 weeks and will consist of 2 administrations of 8 mg IP, 16 mg IP, or placebo (on Day 1 and Day 22). Doses are 3 weeks apart.","title":"8 mg of CYB003","id":114706},{"description":"The Treatment Period will last approximately 6 weeks and will consist of 2 administrations of 8 mg IP, 16 mg IP, or placebo (on Day 1 and Day 22). Doses are 3 weeks apart.","title":"16 mg of CYB003","id":114707},{"description":"The Treatment Period will last approximately 6 weeks and will consist of 2 administrations of 8 mg IP, 16 mg IP, or placebo (on Day 1 and Day 22). Doses are 3 weeks apart.","title":"Placebo","id":114708}],"allocationMethod":"1"},{"id":206873,"businessKey":"3","title":"Follow-up Period","description":"After completing the Day 42 assessments the participants will enter a 6-week Follow-up Period. There will be 4 follow-up visits. During visits on Days 52 and 73, only the C-SSRS, collection of the AEs and concomitant medications will be performed. These 2 visits will be done remotely. The participants must return to the clinic for visits on Days 63 and 84.\n\nParticipants who complete the Follow-up Period and provide consent will be assessed for eligibility to participate in a long-term extension (LTE) trial, which will be outlined in a separate protocol.","blindingMethodCode":"2","blindedRoles":[{"id":206876,"code":1,"name":"Subject"},{"id":206874,"code":2,"name":"Investigator"},{"id":206875,"code":3,"name":"Monitor"}],"blindingDetails":"Blind is not broken until after DBL","armDetails":[{"description":"The Treatment Period will last approximately 6 weeks and will consist of 2 administrations of 8 mg IP, 16 mg IP, or placebo (on Day 1 and Day 22). Doses are 3 weeks apart.","title":"8 mg of CYB003","id":114709},{"description":"The Treatment Period will last approximately 6 weeks and will consist of 2 administrations of 8 mg IP, 16 mg IP, or placebo (on Day 1 and Day 22). Doses are 3 weeks apart.","title":"16 mg of CYB003","id":114710},{"description":"The Treatment Period will last approximately 6 weeks and will consist of 2 administrations of 8 mg IP, 16 mg IP, or placebo (on Day 1 and Day 22). Doses are 3 weeks apart.","title":"Placebo","id":114711}],"allocationMethod":"1"}]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[{"id":38655,"ctNumber":"2024-512665-14-00","sponsorName":"Cybin IRL Limited","fullTitle":"A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans with Major Depressive Disorder (APPROACH)","sponsorAgreementOption":"NON_APPLICABLE","sponsorAgreementOptionName":"NON_APPLICABLE","parentClinicalTrialId":13472,"hasDocument":false,"associatedCtDocs":[]}],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-09-18","conclusionDate":"2026-09-18","therapeuticAreas":[{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"}],"medicalConditions":[{"id":152724,"medicalCondition":"Major Depressive 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