{"ctNumber":"2024-516805-22-00","ctStatus":"Authorised","startDateEU":"2026-06-30","decisionDate":"2025-09-02T09:06:23.906","publishDate":"2026-07-23T03:31:48.547562971","ctPublicStatusCode":3,"authorizedApplication":{"authorizedPartI":{"id":106126,"rowSubjectCount":391,"rowCountriesInfo":[{"eutctId":100000000556,"name":"United Kingdom","isoNumber":826,"isoAlpha2Code":"GB","isoAlpha3Code":"GBR","current":true},{"eutctId":100000000557,"name":"United States","isoNumber":840,"isoAlpha2Code":"US","isoAlpha3Code":"USA","current":true},{"eutctId":100000000329,"name":"Australia","isoNumber":36,"isoAlpha2Code":"AU","isoAlpha3Code":"AUS","current":true}],"products":[{"id":439250,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12374757","productPharmForm":"CAPSULE","euMpNumber":"PRD11770196","prodAuthStatus":1,"prodName":"CYB003","pharmForm":"CAPSULE","sponsorProductCode":"CYB003","activeSubstanceName":"DEUPSILOCIN BESILATE","euSubstNumber":"SUB370808","nameOrg":"CYBIN IRL LIMITED","productSubstances":[{"productPk":"12374757","substancePk":"409339","nameOrg":"CYBIN IRL LIMITED","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"DEUPSILOCIN 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":"16","maxTreatmentPeriod":43,"timeUnitCode":"2","evCode":"PRD11770196","sponsorProductCodeEdit":"CYB003","devices":[],"characteristics":["2"],"routes":["ORAL"],"allSubstancesChemicals":true,"productName":"CYB003","jsonActiveSubstanceNames":"deupsilocin besilate","pharmaceuticalFormDisplay":"CAPSULE"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"A Phase III Long-Term Extension Trial with Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants with Major Depressive Disorder (EXTEND)","fullTitleTranslations":[{"id":8528275,"uuid":"ae0fd040-7bc1-4170-83fa-b2c0a1df627a","attributeTranslation":"Długoterminowe, przedłużone badanie fazy III z opcjonalnym podawaniem dodatkowych dawek CYB003 w celu oceny bezpieczeństwa i długotrwałej skuteczności u osób z ciężkim zaburzeniem depresyjnym (EXTEND)","language":19,"languageDescription":"Polish"},{"id":8528276,"uuid":"ae0fd040-7bc1-4170-83fa-b2c0a1df627a","attributeTranslation":"Μελέτη μακροχρόνιας επέκτασης φάσης III με προαιρετικές πρόσθετες δόσεις CYB003 για την αξιολόγηση της ασφάλειας και της μακροχρόνιας αποτελεσματικότητας σε συμμετέχοντες με μείζονα καταθλιπτική διαταραχή (μελέτη EXTEND)","language":5,"languageDescription":"Greek"}],"publicTitle":"Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)","publicTitleTranslations":[{"id":8528298,"uuid":"301969ef-f6ad-4c88-9ba4-1e4e4d503360","attributeTranslation":"Δοκιμή μακροχρόνιας επέκτασης φάσης ΙΙΙ για την αξιολόγηση της ασφάλειας και της αποτελεσματικότητας του CYB003 στη μείζονα καταθλιπτική διαταραχή (EXTEND)","language":5,"languageDescription":"Greek"},{"id":8528297,"uuid":"301969ef-f6ad-4c88-9ba4-1e4e4d503360","attributeTranslation":"Długoterminowe badanie przedłużone fazy III w celu oceny bezpieczeństwa i skuteczności CYB003 w ciężkim zaburzeniu depresyjnym (EXTEND)","language":19,"languageDescription":"Polish"}],"shortTitle":"CYB003-004","secondaryIdentifyingNumbers":{"nctNumber":{"id":451953,"number":"NCT06605105"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"This is a phase III, long term extension study.","trialCategoryId":96627},"medicalCondition":{"partIMedicalConditions":[{"id":109891,"medicalCondition":"Major Depressive Disorder","medicalConditionTranslations":[{"id":8528215,"uuid":"5f8ca857-251d-4109-baf1-2f74e5687bec","attributeTranslation":"Μείζονα Καταθλιπτική Διαταραχή","language":5,"languageDescription":"Greek"},{"id":8528216,"uuid":"5f8ca857-251d-4109-baf1-2f74e5687bec","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":"5","trialScopeId":319601},{"code":"9","trialScopeId":319600},{"code":"4","trialScopeId":319599}],"mainObjective":"To assess durability of response to IP after initial randomized, double-blind treatment.","mainObjectiveTranslations":[{"id":8528296,"uuid":"91265bc0-a257-4343-9690-f158186e4ba9","attributeTranslation":"Ocena trwałości odpowiedzi na badany produkt po początkowym randomizowanym leczeniu prowadzonym metodą podwójnie ślepej próby.","language":19,"languageDescription":"Polish"},{"id":8528295,"uuid":"91265bc0-a257-4343-9690-f158186e4ba9","attributeTranslation":"Η αξιολόγηση της ανθεκτικότητας της ανταπόκρισης στο ΥΕΠ μετά την αρχική τυχαιοποιημένη, διπλά τυφλή θεραπεία.","language":5,"languageDescription":"Greek"}],"secondaryObjectives":[{"id":368198,"number":1,"secondaryObjective":"To assess the proportion of participants who require either 2 or 3 additional doses of IP during the EXTEND trial. (key secondary)","secondaryObjectiveTranslations":[{"id":8528300,"uuid":"7f455197-46e8-411e-8d3e-abdcb0d0b7bd","attributeTranslation":"Η αξιολόγηση του ποσοστού συμμετεχόντων για τους οποίους απαιτούνται είτε 2 είτε 3 επιπλέον δόσεις ΥΕΠ κατά τη διάρκεια της δοκιμής EXTEND (βασικό δευτερεύον) >.","language":5,"languageDescription":"Greek"},{"id":8528299,"uuid":"7f455197-46e8-411e-8d3e-abdcb0d0b7bd","attributeTranslation":"Ocena odsetka uczestników, którzy wymagają 2 lub 3 dodatkowych dawek badanego produktu podczas badania EXTEND. (kluczowe pierwszorzędowe) >","language":19,"languageDescription":"Polish"}]},{"id":368199,"number":2,"secondaryObjective":"To further assess the long-term efficacy of IP","secondaryObjectiveTranslations":[{"id":8528301,"uuid":"8b563c3e-489f-4c6c-b7c0-5c6aa9b20f28","attributeTranslation":"Η περαιτέρω αξιολόγηση της μακροχρόνιας αποτελεσματικότητας του ΥΕΠ.","language":5,"languageDescription":"Greek"},{"id":8528302,"uuid":"8b563c3e-489f-4c6c-b7c0-5c6aa9b20f28","attributeTranslation":"Dalsza ocena długoterminowej skuteczności badanego produktu.","language":19,"languageDescription":"Polish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":706693,"number":1,"principalInclusionCriteria":"Participant has successfully completed either the APPROACH or EMBRACE trial and received BOTH dose administrations of trial medication.","principalInclusionCriteriaTranslations":[{"id":8528278,"uuid":"8dc355cc-d1b7-4692-8baf-92b954e23d88","attributeTranslation":"Uczestnik pomyślnie ukończył badanie APPROACH lub EMBRACE i otrzymał OBYDWIE dawki badanego leku.","language":19,"languageDescription":"Polish"},{"id":8528277,"uuid":"8dc355cc-d1b7-4692-8baf-92b954e23d88","attributeTranslation":"Ο συμμετέχων ολοκλήρωσε επιτυχώς είτε τη δοκιμή APPROACH είτε τη δοκιμή EMBRACE και έλαβε ΚΑΙ ΤΙΣ ΔΥΟ χορηγήσεις δόσης του φαρμάκου της δοκιμής.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":706694,"number":2,"principalInclusionCriteria":"Participant has continued the same antidepressant medication at the stable dose/day throughout the 12-week APPROACH or EMBRACE trial.","principalInclusionCriteriaTranslations":[{"id":8528279,"uuid":"86335a29-665c-429a-a5c0-1c1a6cced321","attributeTranslation":"Ο συμμετέχων συνέχισε το ίδιο αντικαταθλιπτικό φάρμακο στη σταθερή δόση/ημέρα καθ' όλη τη διάρκεια της δοκιμής 12 εβδομάδων APPROACH ή EMBRACE.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528280,"uuid":"86335a29-665c-429a-a5c0-1c1a6cced321","attributeTranslation":"Uczestnik kontynuował przyjmowanie tych samych leków przeciwdepresyjnych w stałej dawce/dniu przez cały 12-tygodniowy okres trwania badania APPROACH lub EMBRACE.","language":19,"languageDescription":"Polish"}]},{"id":706695,"number":3,"principalInclusionCriteria":"If the participant was engaged in a psychotherapeutic relationship in the APPROACH or EMBRACE trial, they agree to remain in stable and consistent therapy for the remainder of the trial with no changes in the frequency or the setting throughout the trial.","principalInclusionCriteriaTranslations":[{"id":8528282,"uuid":"6b9b8348-d304-4c25-bf60-e302a08c7e57","attributeTranslation":"Jeśli uczestnik był zaangażowany w relację psychoterapeutyczną w ramach badania APPROACH lub EMBRACE, zgadza się przez cały okres badania w dalszym ciągu regularnie korzystać z terapii do końca badania, bez zmiany jej częstotliwości czy warunków, w jakich jest prowadzona.","language":19,"languageDescription":"Polish"},{"id":8528281,"uuid":"6b9b8348-d304-4c25-bf60-e302a08c7e57","attributeTranslation":"Εάν ο συμμετέχων συμμετείχε σε ψυχοθεραπευτική σχέση στη δοκιμή APPROACH ή EMBRACE, συμφωνεί να παραμείνει σε σταθερή και συνεπή θεραπεία για το υπόλοιπο της δοκιμής χωρίς αλλαγές στη συχνότητα ή το σχήμα καθ' όλη τη διάρκεια της δοκιμής.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":706696,"number":4,"principalInclusionCriteria":"Participants can refrain from nicotine use during the dosing session (up to 8 hours).","principalInclusionCriteriaTranslations":[{"id":8528284,"uuid":"702bd3c7-88a5-4ceb-bfaf-e8a857a2ec97","attributeTranslation":"Uczestnicy mogą powstrzymać się od stosowania nikotyny podczas sesji podawania dawki leku (przez czas do 8 godzin).","language":19,"languageDescription":"Polish"},{"id":8528283,"uuid":"702bd3c7-88a5-4ceb-bfaf-e8a857a2ec97","attributeTranslation":"Οι συμμετέχοντες μπορούν να απέχουν από τη χρήση νικοτίνης κατά τη διάρκεια της συνεδρίας δοσολόγησης (έως 8 ώρες).","language":32,"languageDescription":"Greek (Greece)"}]},{"id":706697,"number":5,"principalInclusionCriteria":"Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant’s final dose of IP.","principalInclusionCriteriaTranslations":[{"id":8528286,"uuid":"31d5f8a4-15f7-471a-a107-adfc0b54944c","attributeTranslation":"Οι συμμετέχοντες που είναι ικανοί να παράγουν σπέρμα πρέπει να χρησιμοποιούν προφυλακτικό και σπερματοκτόνο (όπου είναι δημόσια διαθέσιμο) κατά τη διάρκεια της δοκιμής και για 12 εβδομάδες μετά την τελική δόση ΥΕΠ, εάν η σύντροφός τους είναι άτομο με δυνατότητα τεκνοποίησης. Επιπλέον, η σύντροφός τους σε αναπαραγωγική ηλικία πρέπει να συνεχίσει να χρησιμοποιεί μια μέθοδο αντισύλληψης υψηλής αποτελεσματικότητας (δηλαδή με ποσοστό αποτυχίας μικρότερο από 1% όταν χρησιμοποιείται με συνέπεια και σωστά) καθ' όλη τη διάρκεια της δοκιμής έως τις 12 εβδομάδες μετά την τελική δόση ΥΕΠ.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528285,"uuid":"31d5f8a4-15f7-471a-a107-adfc0b54944c","attributeTranslation":"Uczestnicy zdolni do produkcji plemników muszą stosować prezerwatywę i środek plemnikobójczy (jeśli jest publicznie dostępny) w trakcie badania oraz przez 12 tygodni po przyjęciu ostatniej dawki badanego produktu, jeśli ich partnerka jest osobą w wieku rozrodczym. Ponadto partnerka w wieku rozrodczym musi nadal stosować wysoce skuteczną metodę antykoncepcji (tj. o wskaźniku niepowodzeń poniżej 1% pod warunkiem konsekwentnego i prawidłowego stosowania) przez cały okres badania aż do 12 tygodni po podaniu uczestnikowi ostatniej dawki badanego produktu.","language":19,"languageDescription":"Polish"}]},{"id":706698,"number":6,"principalInclusionCriteria":"Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP.","principalInclusionCriteriaTranslations":[{"id":8528287,"uuid":"99d0c0e1-6683-44b7-8a8b-897b0242dbb9","attributeTranslation":"Οι συμμετέχουσες με δυνατότητα τεκνοποίησης (POCBP) που έχουν σύντροφο ικανό να παράγει σπέρμα πρέπει να συμφωνήσουν να συνεχίσουν να χρησιμοποιήσουν μια μέθοδο αντισύλληψης υψηλής αποτελεσματικότητας (δηλαδή με ποσοστό αποτυχίας μικρότερο από 1% όταν χρησιμοποιείται με συνέπεια και σωστά) σε συνδυασμό με τη χρήση προφυλακτικού συν σπερματοκτόνο (όπου διατίθεται δημόσια) κατά τη διάρκεια της δοκιμής και για 12 εβδομάδες μετά την τελική δόση ΥΕΠ.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528288,"uuid":"99d0c0e1-6683-44b7-8a8b-897b0242dbb9","attributeTranslation":"Uczestniczki w wieku rozrodczym (ang. participants of childbearing potential, POCBP), których partner jest zdolny do produkcji plemników, muszą wyrazić zgodę na dalsze stosowanie wysoce skutecznej metody antykoncepcji (tj. o wskaźniku niepowodzeń poniżej 1% przy systematycznym i prawidłowym stosowaniu) w połączeniu ze stosowaniem prezerwatywy i środka plemnikobójczego (jeśli są publicznie dostępne) w trakcie badania i przez 12 tygodni po przyjęciu ostatniej dawki badanego produktu.","language":19,"languageDescription":"Polish"}]},{"id":706699,"number":7,"principalInclusionCriteria":"Female participants must have a negative pregnancy test at Baseline (the end of trial [EOT] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day.","principalInclusionCriteriaTranslations":[{"id":8528290,"uuid":"59c1b74c-e065-4698-81d6-c35ff78e6fe1","attributeTranslation":"Οι γυναίκες συμμετέχουσες πρέπει να έχουν αρνητικό τεστ εγκυμοσύνης κατά την αρχική αξιολόγηση [στην επίσκεψη τέλους της δοκιμής (EOT) στη δοκιμή APPROACH ή EMBRACE] και πριν από τη χορήγηση της δόσης την ημέρα δοσολόγησης","language":32,"languageDescription":"Greek (Greece)"},{"id":8528289,"uuid":"59c1b74c-e065-4698-81d6-c35ff78e6fe1","attributeTranslation":"Uczestniczki badania muszą uzyskać ujemny wynik testu ciążowego na wizycie wyjściowej (na wizycie na zakończenie badania [ang. end of trial, EOT] w badaniu APPROACH lub EMBRACE ) oraz przed podaniem dawki w dniu podawania dawki leku.","language":19,"languageDescription":"Polish"}]},{"id":706700,"number":8,"principalInclusionCriteria":"Postmenopausal status will not be confirmed with follicle-stimulating hormone (FSH) levels. Therefore, participants who may have become post menopausal in the preceding trial but the status was unable to be confirmed, must be willing to continue with the contraception requirements","principalInclusionCriteriaTranslations":[{"id":8528292,"uuid":"4b4eb9a9-e859-473a-894f-01a06e15a2f9","attributeTranslation":"Η μετεμμηνοπαυσιακή κατάσταση δεν θα επιβεβαιωθεί με τα επίπεδα της ωοθυλακιοτρόπου ορμόνης (FSH). Επομένως, οι συμμετέχουσες που μπορεί να είχαν καταστεί μετεμμηνοπαυσιακές στην προηγούμενη δοκιμή, αλλά η κατάσταση δεν ήταν δυνατό να επιβεβαιωθεί, πρέπει να είναι πρόθυμες να συνεχίσουν με τις απαιτήσεις αντισύλληψης.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528291,"uuid":"4b4eb9a9-e859-473a-894f-01a06e15a2f9","attributeTranslation":"Status kobiety po menopauzie nie będzie potwierdzany na podstawie stężenia hormonu folikulotropowego (ng. follicle-stimulating hormone, FSH). W związku z tym uczestniczki, które w poprzednim badaniu mogły mieć status kobiety po menopauzie, ale nie mogło to być potwierdzone, muszą wyrazić zgodę na dalsze stosowanie środków antykoncepcyjnych","language":19,"languageDescription":"Polish"}]},{"id":706701,"number":9,"principalInclusionCriteria":"Participant has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).","principalInclusionCriteriaTranslations":[{"id":8528294,"uuid":"5a06dc3f-e2d2-4ff0-90ec-5ccf47520758","attributeTranslation":"Ο συμμετέχων έχει παράσχει γραπτή συναίνεση μετά από ενημέρωση, η οποία περιλαμβάνει τη συμμόρφωση με τις απαιτήσεις και τους περιορισμούς που αναφέρονται στο έντυπο συναίνεσης μετά από ενημέρωση (ICF).","language":32,"languageDescription":"Greek (Greece)"},{"id":8528293,"uuid":"5a06dc3f-e2d2-4ff0-90ec-5ccf47520758","attributeTranslation":"Uczestnik udzielił pisemnej świadomej zgody, co obejmuje przestrzeganie wymagań i ograniczeń wymienionych w formularzu świadomej zgody (ICF).","language":19,"languageDescription":"Polish"}]}],"principalExclusionCriteria":[{"id":1212994,"number":1,"principalExclusionCriteria":"Any concern by the Principal Investigator that a participant may have undiagnosed or newly developed symptoms of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, attention deficit hyperactivity disorder, bipolar disorder, or borderline personality disorder that manifested in the APPROACH or EMBRACE trial.","principalExclusionCriteriaTranslations":[{"id":8528232,"uuid":"2abcc52a-ba8a-47a8-a866-01f568e3708f","attributeTranslation":"Dowolne obawy Głównego badacza, że u uczestnika mogą występować niezdiagnozowane lub rozwijają się nowe objawy ze spektrum schizofrenii lub innych zaburzeń psychotycznych, w tym schizofrenii, zaburzeń schizoafektywnych, zaburzeń schizotypowych, zaburzeń schizofrenopodobnych, krótkotrwałych zaburzeń psychotycznych, zespołu nadpobudliwości psychoruchowej z deficytem uwagi, zaburzenia dwubiegunowego lub zaburzenia osobowości typu borderline, które ujawniły się w badaniu APPROACH lub EMBRACE.","language":19,"languageDescription":"Polish"},{"id":8528231,"uuid":"2abcc52a-ba8a-47a8-a866-01f568e3708f","attributeTranslation":"Οποιαδήποτε ανησυχία από τον Κύριο Ερευνητή ότι ένας συμμετέχων μπορεί να έχει αδιάγνωστα ή νεοεμφανιζόμενα συμπτώματα φάσματος σχιζοφρένειας ή άλλων ψυχωσικών διαταραχών, συμπεριλαμβανομένων σχιζοφρένειας, σχιζοσυναισθηματικής διαταραχής, σχιζοτυπικής διαταραχής, σχιζοφρενικόμορφης διαταραχής, βραχείας ψυχωσικής διαταραχής, διαταραχής ελλειμματικής προσοχής υπερδραστηριότητας, διπολικής διαταραχής, μεταιχμιακής διαταραχής προσωπικότητας που εκδηλώνονται στη δοκιμή APPROACH ή EMBRACE","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1212995,"number":10,"principalExclusionCriteria":"QT interval corrected for heart rate using Fridericia’s formula >450 msec for males and >470 msec for females following triplicate ECG readings at the Baseline of EXTEND (the EOT Visit in the APPROACH or EMBRACE trial).","principalExclusionCriteriaTranslations":[{"id":8528234,"uuid":"a1ea49b2-2a03-45d9-8e05-4b398296c320","attributeTranslation":"Διάστημα QT διορθωμένο ως προς τον καρδιακό ρυθμό χρησιμοποιώντας τον τύπο Fridericia >450 msec για άνδρες και >470 msec για γυναίκες κατά τη διαλογή, μετά από τριπλές μετρήσεις ΗΚΓ στην αρχική αξιολόγηση (η επίσκεψη EOT της δοκιμής APPROACH/EMBRACE).","language":32,"languageDescription":"Greek (Greece)"},{"id":8528233,"uuid":"a1ea49b2-2a03-45d9-8e05-4b398296c320","attributeTranslation":"Odstęp QT skorygowany o częstość akcji serca przy użyciu wzoru Fridericia >450 ms w przypadku mężczyzn i >470 ms w przypadku kobiet po trzech odczytach EKG na wizycie wyjściowej w badaniu EXTEND (wizyta EOT w badaniu APPROACH lub EMBRACE).","language":19,"languageDescription":"Polish"}]},{"id":1212996,"number":11,"principalExclusionCriteria":"Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND (the EOT Visit in the APPROACH or EMBRACE trial) as defined by Investigator judgment","principalExclusionCriteriaTranslations":[{"id":8528235,"uuid":"7172a0a3-64b2-4a83-a32a-b9f845bbef49","attributeTranslation":"Obecność klinicznie istotnych nieprawidłowości w EKG odnotowanych podczas badania APPROACH lub EMBRACE lub na wizycie wyjściowej w badaniu EXTEND (wizyta EOT w badaniu APPROACH lub EMBRACE) zgodnie z oceną badacza.","language":19,"languageDescription":"Polish"},{"id":8528236,"uuid":"7172a0a3-64b2-4a83-a32a-b9f845bbef49","attributeTranslation":"Παρουσία κλινικά σημαντικών ανωμαλιών στο ΗΚΓ που σημειώνονται κατά τη διάρκεια των δοκιμών APPROACH ή EMBRACE ή στην αρχική αξιολόγηση της EXTEND (η επίσκεψη EOT στη δοκιμή APPROACH ή EMBRACE) όπως ορίζονται από την κρίση του Ερευνητή","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1212997,"number":12,"principalExclusionCriteria":"Clinical evidence of any new disease and/or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the IP.","principalExclusionCriteriaTranslations":[{"id":8528238,"uuid":"965f308d-6cb3-4b2b-b423-ed238b1e82e8","attributeTranslation":"Dowody kliniczne na obecność dowolnej nowej choroby i/lub schorzenia, które może zaburzać wchłanianie, rozprowadzanie się, metabolizm lub wydalanie badanego produktu.","language":19,"languageDescription":"Polish"},{"id":8528237,"uuid":"965f308d-6cb3-4b2b-b423-ed238b1e82e8","attributeTranslation":"Κλινική τεκμηρίωση οποιασδήποτε νόσου ή/και ιατρικής κατάστασης που μπορεί να παρεμποδίσει την απορρόφηση, την κατανομή, τον μεταβολισμό ή την απέκκριση του ΥΕΠ","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1212998,"number":13,"principalExclusionCriteria":"Participant has experienced any new onset organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor) or other medical condition associated with seizure or convulsion risk since Screening in the APPROACH or EMBRACE trial.","principalExclusionCriteriaTranslations":[{"id":8528240,"uuid":"33c4e145-ac2a-4734-a33d-3288e72640dc","attributeTranslation":"Ο συμμετέχων έχει εμφανίσει οποιαδήποτε νέα έναρξη οργανικών διαταραχών του εγκεφάλου (π.χ. επιληψία, επιληπτικές κρίσεις, ενδοκρανιακή υπέρταση, ενδοκρανιακή αιμορραγία και ανευρυσματική νόσος, όγκος στον εγκέφαλο) ή άλλη ιατρική κατάσταση που σχετίζεται με επιληπτική κρίση ή ακούσιο μυϊκό σπασμό από τη διαλογή στη δοκιμή APPROACH ή EMBRACE.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528239,"uuid":"33c4e145-ac2a-4734-a33d-3288e72640dc","attributeTranslation":"U uczestnika wystąpiły dowolne nowe, początkowe i organiczne zaburzenia mózgu (np. padaczka, napad, nadciśnienie wewnątrzczaszkowe, krwawienie wewnątrzczaszkowe, tętniak, guz mózgu) lub inne schorzenie związane z ryzykiem wystąpienia napadów lub drgawek, począwszy od wizyty wyjściowej w badaniu APPROACH lub EMBRACE.","language":19,"languageDescription":"Polish"}]},{"id":1212999,"number":14,"principalExclusionCriteria":"Safety laboratory values at the Baseline of EXTEND (the EOT Visit in the APPROACH or EMBRACE trial) for aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT) or total bilirubin (TBil) levels ≥1.5 × the upper limit of normal (ULN). 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":8528241,"uuid":"ddfdd16d-c0e3-4f90-8039-76a012caf9c2","attributeTranslation":"Wyniki badań laboratoryjnych dotyczące bezpieczeństwa na wizycie wyjściowej w badaniu EXTEND (wizyta EOT w badaniu APPROACH lub EMBRACE) odnośnie do aminotransferazy asparaginianowej (AST), aminotransferazy alaninowej (ALT), gamma-glutamylotransferazy (GGT) lub całkowitej bilirubiny (TBil) ≥1,5 × górna granica normy (GGN). 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":8528242,"uuid":"ddfdd16d-c0e3-4f90-8039-76a012caf9c2","attributeTranslation":"Εργαστηριακές τιμές ασφάλειας στην αρχική αξιολόγηση της EXTEND (η επίσκεψη EOT στη δοκιμή APPROACH ή EMBRACE) για επίπεδα ασπαρτικής αμινοτρανσφεράσης (AST), αμινοτρανσφεράσης της αλανίνης (ALT), γ-γλουταμυλοτρανσφεράσης (GGT) ή ολικής χολερυθρίνης (TBil) ≥ 1,5 × ανώτερου φυσιολογικού ορίου (ULN). 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":1213000,"number":15,"principalExclusionCriteria":"Participants that do not agree to abstain from drugs of abuse for the entire trial and/or do not agree to refrain from alcohol use from 48 hours before each scheduled visit until discharge from the trial site","principalExclusionCriteriaTranslations":[{"id":8528244,"uuid":"7c4288af-907e-4b51-9a25-48fba2613492","attributeTranslation":"Συμμετέχοντες που δεν συμφωνούν να απέχουν από τα ναρκωτικά κατάχρησης για ολόκληρη τη δοκιμή ή/και δεν συμφωνούν να απέχουν από τη χρήση αλκοόλ από 48 ώρες πριν από κάθε προγραμματισμένη επίσκεψη έως το εξιτήριο από το κέντρο της δοκιμής","language":32,"languageDescription":"Greek (Greece)"},{"id":8528243,"uuid":"7c4288af-907e-4b51-9a25-48fba2613492","attributeTranslation":"Uczestnicy, którzy nie zgodzą się na powstrzymanie się od zażywania narkotyków przez cały okres badania i/lub nie wyrażą zgody na powstrzymanie się od spożywania alkoholu w okresie od 48 godzin przed każdą planowaną wizytą do momentu wypisania z ośrodka badawczego.","language":19,"languageDescription":"Polish"}]},{"id":1213001,"number":16,"principalExclusionCriteria":"Sensitivity or suspected sensitivity to IP noted in the APPROACH or EMBRACE trial","principalExclusionCriteriaTranslations":[{"id":8528246,"uuid":"3e088059-8380-44e3-a61f-c27b308aac76","attributeTranslation":"W badaniu APPROACH lub EMBRACE stwierdzono wrażliwość lub podejrzenie wrażliwości na badany produkt.","language":19,"languageDescription":"Polish"},{"id":8528245,"uuid":"3e088059-8380-44e3-a61f-c27b308aac76","attributeTranslation":"Ευαισθησία ή εικαζόμενη ευαισθησία στο ΥΕΠ που σημειώνεται στη δοκιμή APPROACH ή EMBRACE.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213002,"number":17,"principalExclusionCriteria":"Participants that are unable to abstain from strenuous exercise within 48 hours before each clinic visit. Other eligibility considerations (e.g., participant personal circumstances, behavior, and/or any current problem or future plans 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":8528247,"uuid":"3ba9f23f-b8d6-4108-a883-19998d036506","attributeTranslation":"Uczestnicy, którzy nie są w stanie powstrzymać się od forsownego wysiłku fizycznego w ciągu 48 godzin przed każdą wizytą w ośrodku. Inne kryteria kwalifikujące według oceny badacza (np. osobiste okoliczności uczestnika, zachowanie i/lub jakiekolwiek bieżące problemy lub plany na przyszłość, które mogłyby przeszkodzić w uczestnictwie lub które są nie do pogodzenia z nawiązaniem relacji lub bezpieczną ekspozycją na psylocynę).","language":19,"languageDescription":"Polish"},{"id":8528248,"uuid":"3ba9f23f-b8d6-4108-a883-19998d036506","attributeTranslation":"Συμμετέχοντες που δεν μπορούν να απέχουν από την έντονη άσκηση εντός 48 ωρών πριν από κάθε επίσκεψη στην κλινική. Άλλοι παράγοντες επιλεξιμότητας (π.χ. προσωπικές περιστάσεις του συμμετέχοντα, συμπεριφορά ή/και οποιοδήποτε τρέχον πρόβλημα ή μελλοντικά σχέδια που θα μπορούσαν να παρεμποδίσουν τη συμμετοχή ή που δεν είναι συμβατά με την εδραίωση σχέσης ή την ασφαλή έκθεση στην ψιλοκίνη), όπως κρίνεται από τον Ερευνητή","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213003,"number":18,"principalExclusionCriteria":"Participants capable of producing sperm that are unable to abstain from sperm donation until 12 weeks after final dosing.","principalExclusionCriteriaTranslations":[{"id":8528249,"uuid":"74d109fe-2fec-4e94-a703-37ea45ac3b5e","attributeTranslation":"Uczestnicy zdolni do produkcji nasienia, którzy nie mogą powstrzymać się od oddawania nasienia przez okres do 12 tygodni po otrzymaniu ostatniej dawki leku.","language":19,"languageDescription":"Polish"},{"id":8528250,"uuid":"74d109fe-2fec-4e94-a703-37ea45ac3b5e","attributeTranslation":"Συμμετέχοντες ικανοί να παράγουν σπέρμα που δεν μπορούν να απέχουν από τη δωρεά σπέρματος έως 12 εβδομάδες μετά την τελική δοσολόγηση.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213004,"number":19,"principalExclusionCriteria":"Participants of childbearing potential who have a positive urine test and, subsequently, confirmatory serum pregnancy test at the Baseline (the EOT Visit in the APPROACH or EMBRACE trial), OR any time in the trial, OR planning to conceive, OR unwilling to abstain from egg (ova) donation until 12 weeks after final dosing","principalExclusionCriteriaTranslations":[{"id":8528251,"uuid":"a4dc672d-d97c-44af-8fac-3dad59a7d8b4","attributeTranslation":"Uczestniczki w wieku rozrodczym, u których wynik badania z moczu jest pozytywny, a następnie test ciążowy z surowicy potwierdza wynik na wizycie wyjściowej (wizyta EOT w badaniu APPROACH lub EMBRACE), LUB w dowolnym momencie badania, LUB które planują zajść w ciążę, LUB nie chcą powstrzymać się od oddania komórek jajowych (jajeczek) przez okres do 12 tygodni po otrzymaniu ostatniej dawki leku.","language":19,"languageDescription":"Polish"},{"id":8528252,"uuid":"a4dc672d-d97c-44af-8fac-3dad59a7d8b4","attributeTranslation":"Συμμετέχουσες με δυνατότητα τεκνοποίησης που έχουν θετικό τεστ ούρων και, στη συνέχεια, επιβεβαιωτικό τεστ εγκυμοσύνης ορού κατά την αρχική αξιολόγηση (η επίσκεψη EOT στη δοκιμή APPROACH ή EMBRACE) ή οποιαδήποτε στιγμή κατά τη δοκιμή ή προγραμματίζουν να συλλάβουν ή δεν επιθυμούν να απέχουν από δωρεά ωαρίων μέχρι 12 εβδομάδες μετά την τελική δοσολόγηση.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213005,"number":2,"principalExclusionCriteria":"New awareness of a participant’s family member being diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives) since Screening in the APPROACH or EMBRACE trial.","principalExclusionCriteriaTranslations":[{"id":8528253,"uuid":"8246bb10-f725-409c-a558-cb539635b5d0","attributeTranslation":"Πρόσφατη ενημέρωση ότι μέλος της οικογένειας ενός συμμετέχοντος έχει διαγνωστεί με σχιζοφρένεια, σχιζοσυναισθηματική διαταραχή ή διπολική διαταραχή τύπου 1 (συγγενείς πρώτου βαθμού) από τη διαλογή στη δοκιμή APPROACH ή EMBRACE.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528254,"uuid":"8246bb10-f725-409c-a558-cb539635b5d0","attributeTranslation":"Uzyskanie informacji, że u członka rodziny uczestnika zdiagnozowano schizofrenię, zaburzenie schizoafektywne lub zaburzenie dwubiegunowe typu 1 (pierwszy stopień pokrewieństwa) od czasu badania przesiewowego w ramach badania APPROACH lub EMBRACE.","language":19,"languageDescription":"Polish"}]},{"id":1213006,"number":20,"principalExclusionCriteria":"Any concern that participants may be at risk of developing serotonin syndrome with dosing of IP in the EXTEND trial","principalExclusionCriteriaTranslations":[{"id":8528256,"uuid":"70f5fe4e-28aa-46e2-9566-9db055fd5c75","attributeTranslation":"Οποιαδήποτε ανησυχία ότι οι συμμετέχοντες ενδέχεται να κινδυνεύουν να εμφανίσουν σύνδρομο σεροτονίνης με τη δοσολόγηση του ΥΕΠ στη δοκιμή EXTEND.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528255,"uuid":"70f5fe4e-28aa-46e2-9566-9db055fd5c75","attributeTranslation":"Dowolne obawy, że uczestnicy badania EXTEND mogą być narażeni na ryzyko wystąpienia zespołu serotoninowego w związku z przyjmowaniem badanego produktu","language":19,"languageDescription":"Polish"}]},{"id":1213007,"number":21,"principalExclusionCriteria":"Participant is unwilling to consent to audio and video recording of psychological support and dosing sessions","principalExclusionCriteriaTranslations":[{"id":8528257,"uuid":"988c1460-6ae9-4369-91ae-ea37d3dbf588","attributeTranslation":"Ο συμμετέχων δεν είναι πρόθυμος να συναινέσει στην εγγραφή ήχου και βίντεο ψυχολογικής υποστήριξης και συνεδριών δοσολόγησης.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528258,"uuid":"988c1460-6ae9-4369-91ae-ea37d3dbf588","attributeTranslation":"Uczestnik nie wyraża zgody na nagrywanie dźwięku i obrazu podczas sesji wsparcia psychologicznego i sesji podawania dawki leku.","language":19,"languageDescription":"Polish"}]},{"id":1213008,"number":22,"principalExclusionCriteria":"Investigator’s decision that, for any reason, a participant may be unsuitable for enrollment.","principalExclusionCriteriaTranslations":[{"id":8528260,"uuid":"191a90f5-8c7f-41a0-ad69-769d38c4fcbe","attributeTranslation":"Decyzja badacza stwierdzająca, że uczestnik z dowolnego powodu nie kwalifikuje się do włączenia do badania.","language":19,"languageDescription":"Polish"},{"id":8528259,"uuid":"191a90f5-8c7f-41a0-ad69-769d38c4fcbe","attributeTranslation":"Απόφαση του ερευνητή ότι, για οποιονδήποτε λόγο, ο συμμετέχων μπορεί να είναι ακατάλληλος για εγγραφή","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213009,"number":3,"principalExclusionCriteria":"Significant suicide risk as defined by (a) suicidal ideation as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C SSRS) at the Baseline of EXTEND (the EOT Visit in the APPROACH or EMBRACE trial), (b) participants have experienced an adverse event of suicidal ideation/attempt or self-harm in the APPROACH or EMBRACE trial, (c) have had a >1 point change in item 1 or 2 of the C SSRS performed at the EOT Visit in the APPROACH or EMBRACE trial, compared to their score on these items from the Screening Visit of the APPROACH or EMBRACE trial","principalExclusionCriteriaTranslations":[{"id":8528261,"uuid":"a8323e43-1b9a-456e-8074-0d2cb00c11d1","attributeTranslation":"Istotne ryzyko samobójstwa zdefiniowane jako (a) myśli samobójcze potwierdzone w punktach 4 lub 5 w Skali oceny skłonności samobójczych opracowanej na Uniwersytecie Columbia (ang. Columbia-Suicide Severity Rating Scale, C-SSRS) na wizycie wyjściowej w badaniu EXTEND (na wizycie EOT w badaniu APPROACH lub EMBRACE), (b) uczestnicy doświadczyli zdarzenia niepożądanego w postaci myśli samobójczych/próby samobójczej lub samookaleczenia w badaniu APPROACH lub EMBRACE, (c) uzyskali wynik >1 odnośnie do zmiany w pozycji 1 lub 2 w skali C-SSRS przeprowadzonej podczas wizyty EOT w badaniu APPROACH lub EMBRACE, w porównaniu z wynikiem w tych pozycjach uzyskanym podczas wizyty przesiewowej w badaniu APPROACH lub EMBRACE.","language":19,"languageDescription":"Polish"},{"id":8528262,"uuid":"a8323e43-1b9a-456e-8074-0d2cb00c11d1","attributeTranslation":"Σημαντικός κίνδυνος αυτοκτονίας όπως ορίζεται από (α) αυτοκτονικό ιδεασμό όπως επικυρώνεται στα στοιχεία 4 ή 5 της Columbia-Suicide Severity Rating Scale (κλίμακα αξιολόγησης σοβαρότητας αυτοκτονικού ιδεασμού του Columbia, C-SSRS) στην αρχική αξιολόγηση της EXTEND (η επίσκεψη EOT στη δοκιμή APPROACH ή EMBRACE), (β ) οι συμμετέχοντες έχουν εμφανίσει ανεπιθύμητο συμβάν αυτοκτονικού ιδεασμού/απόπειρας αυτοκτονίας ή αυτοτραυματισμού στη δοκιμή APPROACH ή EMBRACE, (γ) είχαν μεταβολή >1 βαθμού στο στοιχείο 1 ή 2 της C-SSRS που διενεργείται στην επίσκεψη EOT στη δοκιμή APPROACH ή EMBRACE, σε σύγκριση με τη βαθμολογία τους σε αυτά τα στοιχεία από την επίσκεψη διαλογής της δοκιμής APPROACH ή EMBRACE.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213010,"number":4,"principalExclusionCriteria":"Use of a prescription medicine other than a stable chronic dose of antidepressant medication, except those permitted during the APPROACH or EMBRACE trial or approved by a Medical Monitor","principalExclusionCriteriaTranslations":[{"id":8528264,"uuid":"1d0765f7-f0ab-465d-9207-99212906c66b","attributeTranslation":"Stosowanie leków wydawanych na receptę innych niż stałe dawki leków przeciwdepresyjnych, z wyjątkiem leków dozwolonych podczas badania APPROACH lub EMBRACE lub zatwierdzonych przez monitora medycznego.","language":19,"languageDescription":"Polish"},{"id":8528263,"uuid":"1d0765f7-f0ab-465d-9207-99212906c66b","attributeTranslation":"Χρήση συνταγογραφούμενου φαρμάκου εκτός από σταθερή χρόνια δόση αντικαταθλιπτικού φαρμάκου, με εξαίρεση αυτά που επιτρέπονται κατά τη δοκιμή APPROACH ή EMBRACE ή που εγκρίνονται από έναν Υπεύθυνο Ιατρικής Παρακολούθησης.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213011,"number":5,"principalExclusionCriteria":"Development of clinically relevant abnormal physical health condition or need of treatment for a condition that could interfere with the trial or pose an unacceptable risk to the participant in this trial 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":8528265,"uuid":"513d492d-f421-45e1-98a1-3b295bb27bf0","attributeTranslation":"Εμφάνιση κλινικά συναφούς μη φυσιολογικής κατάστασης της σωματικής υγείας ή ανάγκη θεραπείας για μια κατάσταση που θα μπορούσε να επηρεάσει τη δοκιμή ή να θέσει μη αποδεκτό κίνδυνο για τον συμμετέχοντα σε αυτήν τη δοκιμή, όπως κρίνεται από τον Ερευνητή [συμπεριλαμβανομένων μεταξύ άλλων νευρολογικής, καρδιαγγειακής, αναπνευστικής, γαστρεντερικής (συμπερ. δυσπεψίας ή γαστροισοφαγικής παλινδρομική νόσου), ηπατικής ή νεφρικής διαταραχής].","language":32,"languageDescription":"Greek (Greece)"},{"id":8528266,"uuid":"513d492d-f421-45e1-98a1-3b295bb27bf0","attributeTranslation":"Rozwój klinicznie istotnego nieprawidłowego stanu zdrowia fizycznego lub konieczność leczenia schorzenia, które mogłoby mieć wpływ na badanie lub stanowić niedopuszczalne ryzyko dla uczestnika tego badania, według oceny badacza (w tym między innymi zaburzenia neurologiczne, sercowo-naczyniowe, oddechowe, żołądkowo-jelitowe [w tym dyspepsja lub choroba refluksowa żołądkowo-przełykowa], zaburzenia wątroby lub nerek).","language":19,"languageDescription":"Polish"}]},{"id":1213012,"number":6,"principalExclusionCriteria":"Participants with renal insufficiency (eGFR ≤59 mL/min/1.73 m2).","principalExclusionCriteriaTranslations":[{"id":8528268,"uuid":"b4882272-76fb-4038-a22b-467bea2bb449","attributeTranslation":"Συμμετέχοντες με νεφρική ανεπάρκεια (eGFR ≤59 mL/min/1,73 m2).","language":32,"languageDescription":"Greek (Greece)"},{"id":8528267,"uuid":"b4882272-76fb-4038-a22b-467bea2bb449","attributeTranslation":"Uczestnicy z niewydolnością nerek (eGFR ≤59 ml/min/1,73 m²).","language":19,"languageDescription":"Polish"}]},{"id":1213013,"number":7,"principalExclusionCriteria":"Participants with stable hypothyroidism or hyperthyroidism, at Screening in the APPROACH or EMBRACE trial that are unable to continue appropriate medication until the final visit in the EXTEND trial.","principalExclusionCriteriaTranslations":[{"id":8528270,"uuid":"74a6609c-9bb5-42eb-b579-6316c5727282","attributeTranslation":"Uczestnicy ze stabilną niedoczynnością lub nadczynnością tarczycy, biorący udział w badaniu przesiewowym w ramach badania APPROACH lub EMBRACE, którzy nie są w stanie kontynuować przyjmowania odpowiednich leków do ostatniej wizyty w badaniu EXTEND.","language":19,"languageDescription":"Polish"},{"id":8528269,"uuid":"74a6609c-9bb5-42eb-b579-6316c5727282","attributeTranslation":"Συμμετέχοντες με σταθερό υποθυρεοειδισμό ή υπερθυρεοειδισμό, κατά τη διαλογή στη δοκιμή APPROACH ή EMBRACE που δεν είναι σε θέση να συνεχίσουν το κατάλληλο φάρμακο μέχρι την τελική επίσκεψη στη δοκιμή EXTEND","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213014,"number":8,"principalExclusionCriteria":"Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial.","principalExclusionCriteriaTranslations":[{"id":8528272,"uuid":"4bfdde01-159a-4faf-8e9d-2c69bacf5542","attributeTranslation":"Klinicznie istotna arytmia lub zmiany w pomiarach parametrów życiowych odnotowane podczas dowolnej sesji podawania dawki leku w badaniu APPROACH lub EMBRACE.","language":19,"languageDescription":"Polish"},{"id":8528271,"uuid":"4bfdde01-159a-4faf-8e9d-2c69bacf5542","attributeTranslation":"Κλινικά συναφής αρρυθμία ή μεταβολές ζωτικών σημείων που σημειώνονται κατά τη διάρκεια οποιασδήποτε από τις συνεδρίες δοσολόγησης στη δοκιμή APPROACH ή EMBRACE.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1213015,"number":9,"principalExclusionCriteria":"Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically abnormal results for heart rate (resting supine heart rate >100 beats per minute) or blood pressure (BP) (resting supine systolic BP >139 mmHg or resting supine diastolic BP >89 mmHg) at Baseline (EOT of APPROACH/EMBRACE). Participants with well controlled hypertension and who have been on stable dose/doses of either 1 or 2 allowable antihypertensive medications for ≥4 weeks prior to Baseline are permitted.","principalExclusionCriteriaTranslations":[{"id":8528273,"uuid":"d4e4b9d3-38bc-43a0-b284-5a112b767f54","attributeTranslation":"Aktualna diagnoza niekontrolowanego nadciśnienia lub arytmii lub klinicznie nieprawidłowe wyniki pomiaru częstości akcji serca (częstość akcji serca w stanie spoczynku w pozycji leżącej na plecach >100 uderzeń na minutę) lub ciśnienia krwi (RR) (ciśnienie skurczowe w stanie spoczynku w pozycji leżącej na plecach RR >139 mmHg lub ciśnienie rozkurczowe w stanie spoczynku w pozycji leżącej na plecach RR >89 mmHg) na wizycie wyjściowej (EOT w badaniu APPROACH/EMBRACE). Dozwolony jest udział uczestników z dobrze kontrolowanym nadciśnieniem tętniczym, którzy przyjmowali stałą dawkę/stałe dawki 1 lub 2 dozwolonych leków przeciwnadciśnieniowych przez ≥4 tygodnie przed wizytą wyjściową.","language":19,"languageDescription":"Polish"},{"id":8528274,"uuid":"d4e4b9d3-38bc-43a0-b284-5a112b767f54","attributeTranslation":"Τρέχουσα διάγνωση αρρύθμιστης υπέρτασης ή αρρυθμίας ή κλινικά μη φυσιολογικά αποτελέσματα για τον καρδιακό ρυθμό (καρδιακός ρυθμός ηρεμίας σε ύπτια θέση >100 παλμοί ανά λεπτό) ή αρτηριακή πίεση (ΑΠ) (συστολική ΑΠ ηρεμίας σε ύπτια θέση >139 mmHg ή διαστολική ΑΠ >89 mmHg) στην αρχική αξιολόγηση (EOT της APPROACH/EMBRACE). Επιτρέπονται συμμετέχοντες με επαρκώς ελεγχόμενη υπέρταση οι οποίοι έχουν λάβει σταθερές δόσεις είτε 1 είτε 2 επιτρεπόμενων αντιυπερτασικών φαρμάκων για ≥4 εβδομάδες πριν από την αρχική αξιολόγηση.","language":32,"languageDescription":"Greek (Greece)"}]}]},"endPoint":{"primaryEndPoints":[{"id":827622,"number":1,"endPoint":"Time to first relapse from Baseline of EXTEND trial in participants who have had a stable response in either the APPROACH or EMBRACE trial","isPrimary":true,"endPointTranslations":[{"id":8528217,"uuid":"72b9cc81-8ccb-4c23-8d0a-05f0e80730d3","attributeTranslation":"Χρόνος έως την πρώτη υποτροπή από την αρχική αξιολόγηση της δοκιμής EXTEND σε συμμετέχοντες που είχαν σταθερή ανταπόκριση είτε στη δοκιμή APPROACH είτε στη δοκιμή EMBRACE","language":32,"languageDescription":"Greek (Greece)"},{"id":8528218,"uuid":"72b9cc81-8ccb-4c23-8d0a-05f0e80730d3","attributeTranslation":"Czas do pierwszego nawrotu od punktu początkowego badania EXTEND u uczestników, u których wystąpiła stabilna odpowiedź w badaniu APPROACH lub EMBRACE","language":19,"languageDescription":"Polish"}]}],"secondaryEndPoints":[{"id":827623,"number":1,"endPoint":"Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 2 additional doses of IP in EXTEND.","isPrimary":false,"endPointTranslations":[{"id":8528219,"uuid":"4f47c36a-f0e5-4208-b161-7aef05e7effa","attributeTranslation":"Procent uczestników, u których wystąpiła bądź nie wystąpiła odpowiedź na leczenie w badaniu APPROACH lub EMBRACE i wymagają podania 2 dodatkowych dawek badanego produktu w badaniu EXTEND.","language":19,"languageDescription":"Polish"},{"id":8528220,"uuid":"4f47c36a-f0e5-4208-b161-7aef05e7effa","attributeTranslation":"Ποσοστό συμμετεχόντων που είναι ανταποκρινόμενοι ή μη ανταποκρινόμενοι στην APPROACH ή στην EMBRACE και για τους οποίους απαιτούνται 2 επιπλέον δόσεις ΥΕΠ στην EXTEND.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":827624,"number":2,"endPoint":"Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 3 additional doses of IP in EXTEND.","isPrimary":false,"endPointTranslations":[{"id":8528221,"uuid":"a9bd2964-a2f5-470a-a4ba-562395dd5603","attributeTranslation":"Ποσοστό συμμετεχόντων που είναι ανταποκρινόμενοι ή μη ανταποκρινόμενοι στην APPROACH ή στην EMBRACE και για τους οποίους απαιτούνται 3 επιπλέον δόσεις ΥΕΠ στην EXTEND.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528222,"uuid":"a9bd2964-a2f5-470a-a4ba-562395dd5603","attributeTranslation":"Procent uczestników, u których wystąpiła bądź nie wystąpiła odpowiedź na leczenie w badaniu APPROACH lub EMBRACE i wymagają podania 3 dodatkowych dawek badanego produktu w badaniu EXTEND.","language":19,"languageDescription":"Polish"}]},{"id":827625,"number":3,"endPoint":"Percentage of participants with sustained response defined as absence of a relapse after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score above 50% decrease in MADRS total score permitted.","isPrimary":false,"endPointTranslations":[{"id":8528224,"uuid":"db8f57cc-a24b-4120-b06a-4fc53aceb8fd","attributeTranslation":"Ως ποσοστό συμμετεχόντων με διατηρούμενη ανταπόκριση ορίζεται η απουσία υποτροπής μετά από χορήγηση 2 δόσεων ΥΕΠ στην APPROACH ή στην EMBRACE έως το καταληκτικό σημείο της EXTEND με 1 αύξηση στη συνολική βαθμολογία MADRS πάνω από 50% μείωση στη συνολική βαθμολογία MADRS να επιτρέπεται.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528223,"uuid":"db8f57cc-a24b-4120-b06a-4fc53aceb8fd","attributeTranslation":"Procent uczestników z utrzymującą się odpowiedzią zdefiniowaną jako brak nawrotu po podaniu 2 dawek badanego produktu w badaniu APPROACH lub EMBRACE do punktu końcowego w badaniu EXTEND z dozwolonym 1 wzrostem całkowitego wyniku w skali oceny depresji Montgomery-Asberg (Montgomery-Asberg Depression Rating Scale, MADRS) powyżej 50% spadku całkowitego wyniku w skali MADRS.","language":19,"languageDescription":"Polish"}]},{"id":827626,"number":4,"endPoint":"Percentage of participants with sustained remission defined as MADRS total score ≤10 after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score >10 permitted.","isPrimary":false,"endPointTranslations":[{"id":8528225,"uuid":"34d37bc8-5240-4f74-a1da-fb5d76ec06c4","attributeTranslation":"Ως ποσοστό συμμετεχόντων με διατηρούμενη ύφεση ορίζεται η συνολική βαθμολογία MADRS ≤10 μετά τη χορήγηση 2 δόσεων ΥΕΠ στην APPROACH ή στην EMBRACE έως το καταληκτικό σημείο της EXTEND με 1 αύξηση στη συνολική βαθμολογία MADRS >10 να επιτρέπεται.","language":32,"languageDescription":"Greek (Greece)"},{"id":8528226,"uuid":"34d37bc8-5240-4f74-a1da-fb5d76ec06c4","attributeTranslation":"Procent uczestników z utrzymującą się remisją zdefiniowaną jako całkowity wynik w skali MADRS ≤10 po podaniu 2 dawek badanego produktu w badaniu APPROACH lub EMBRACE do punktu końcowego w badaniu EXTEND z dozwolonym 1 wzrostem całkowitego wyniku w skali MADRS wynoszącym >10.","language":19,"languageDescription":"Polish"}]},{"id":827627,"number":5,"endPoint":"Percentage of responders and remitters to 2 doses of IP administered in EXTEND who later relapse.","isPrimary":false,"endPointTranslations":[{"id":8528227,"uuid":"fe76ff0f-2696-4502-a21f-0b8ba1061807","attributeTranslation":"Procent uczestników reagujących na leczenie i wykazujących remisję po podaniu 2 dawek badanego produktu w badaniu EXTEND, u których później nastąpił nawrót choroby.","language":19,"languageDescription":"Polish"},{"id":8528228,"uuid":"fe76ff0f-2696-4502-a21f-0b8ba1061807","attributeTranslation":"Ποσοστό συμμετεχόντων που επέδειξαν ανταπόκριση και ύφεση σε 2 δόσεις ΥΕΠ που χορηγήθηκαν στην EXTEND και αργότερα υποτροπιάζουν.","language":32,"languageDescription":"Greek (Greece)"}]},{"id":827628,"number":6,"endPoint":"Change from Baseline to last visit in the total MADRS score in participants who did not respond to IP in APPROACH or EMBRACE","isPrimary":false,"endPointTranslations":[{"id":8528229,"uuid":"21554507-48f5-41ed-8ea7-2a42ed342b45","attributeTranslation":"Zmiana całkowitego wyniku w skali MADRS od wizyty początkowej do ostatniej wizyty u uczestników, u których nie wystąpiła odpowiedź na działanie badanego produktu w badaniu APPROACH lub EMBRACE.","language":19,"languageDescription":"Polish"},{"id":8528230,"uuid":"21554507-48f5-41ed-8ea7-2a42ed342b45","attributeTranslation":"Μεταβολή από την αρχική αξιολόγηση έως την τελευταία επίσκεψη στη συνολική βαθμολογία MADRS σε συμμετέχοντες που δεν ανταποκρίθηκαν στο ΥΕΠ στην APPROACH ή στην EMBRACE.","language":32,"languageDescription":"Greek (Greece)"}]}]},"trialDuration":{"estimatedGlobalEndDate":"2028-01-15","estimatedEndDate":"2027-09-06","estimatedRecruitmentStartDate":"2025-08-22"},"sourceOfMonetarySupport":[],"populationOfTrialSubjects":{"ageRanges":[{"id":291224,"ageRangeCategoryCode":"4","ageRangeCategory":"4"},{"id":291223,"ageRangeCategoryCode":"3","ageRangeCategory":"3"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":true},"individualParticipantData":{"planToShareIPD":"2"}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[{"id":27259,"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 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