{"ctNumber":"2024-517747-31-00","ctStatus":"Authorised","startDateEU":"2022-07-22","decisionDate":"2024-11-11T13:45:49.07","publishDate":"2026-09-24T03:33:54.753875353","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":142286,"rowSubjectCount":0,"products":[{"id":593566,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11505378","productPharmForm":"CAPSULE, HARD","euMpNumber":"PRD11505378","prodAuthStatus":1,"pharmForm":"CAPSULE, HARD","sponsorProductCode":"SUB08950MIG","activeSubstanceName":"MIDAZOLAM","euSubstNumber":"SUB08950MIG","nameOrg":"NARODNI USTAV DUSEVNIHO ZDRAVI","productSubstances":[{"productPk":"11505378","substancePk":"382389","nameOrg":"NARODNI USTAV DUSEVNIHO ZDRAVI","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"MIDAZOLAM","substanceEvCode":"SUB08950MIG"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"2","orphanDrugEdit":false,"doseUom":"mg 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extension","fullTitleTranslations":[{"id":12040313,"uuid":"181bf081-7cda-49fb-b02f-438364df08b5","attributeTranslation":"Psilocybin – strategie rychlé antidepresivní odpovědi u deprese komorbidní s onkologickým onemocněním, randomizovaná dvojitě zaslepená studie s možností vstupu do otevřené extenze.","language":2,"languageDescription":"Czech"}],"publicTitle":"Psilocybin - a  strategy of rapid antidepressant response in depression comorbid with cancer,a randomized double-blind study with the possibility of entering open extension","publicTitleTranslations":[{"id":12040321,"uuid":"65f48d80-40d8-413e-baa4-71b626981bfd","attributeTranslation":"Psilocybin – strategie rychlé antidepresivní odpovědi u deprese komorbidní s onkologickým onemocněním, randomizovaná dvojitě zaslepená studie s možností vstupu do otevřené extenze.","language":2,"languageDescription":"Czech"}],"shortTitle":"PSIKET_002CZE","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"exploratory phase II trial with unauthorized IMPs","trialCategoryId":131606},"medicalCondition":{"partIMedicalConditions":[{"id":149126,"medicalCondition":"Depressive disorder comorbid with cancer","medicalConditionTranslations":[{"id":12040269,"uuid":"c666d904-6ec6-4340-893b-1f329eeb259a","attributeTranslation":"Depresivní porucha komorbidní s onkologickým onemocněním","language":2,"languageDescription":"Czech"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000024331,"version":"20.0","level":"PT","termName":"Depression","classificationCode":"10012378","organClass":100000004873,"active":false}]},"trialObjective":{"trialScopes":[{"code":"4","trialScopeId":432831},{"code":"5","trialScopeId":432833},{"code":"3","trialScopeId":432832}],"mainObjective":"evaluation of the effectiveness of psilocybin (active substance 1) in depression comorbid to oncological disease treatement in 4 weeks\n(day 28) from its administration, compared to ketamine (active substance 2) and midazolam (control\nsubstance)","mainObjectiveTranslations":[{"id":12040320,"uuid":"5239ec60-9690-4b3a-95a5-7dbb8ba505fe","attributeTranslation":"zhodnocení účinnosti psilocybinu (aktivní látka 1) v léčbě deprese komorbidní k onkologickému onemocnění za 4 týdny (28. den) od jeho podání, srovnáním s antidepresivně působícím ketaminem (aktivní látka 2) a midazolamem (kontrolní látka)","language":2,"languageDescription":"Czech"}],"secondaryObjectives":[{"id":509426,"number":1,"secondaryObjective":"evaluation of the onset and duration of the antidepressant effect of psilocybin and ketamine","secondaryObjectiveTranslations":[{"id":12040322,"uuid":"3bf43cc1-ce66-42aa-ad52-7a75bc03f85c","attributeTranslation":"vyhodnocení nástupu a délky trvání antidepresivního účinku psilocybinu a ketaminu","language":2,"languageDescription":"Czech"}]},{"id":509427,"number":2,"secondaryObjective":"evaluation of the rate of onset of the antidepressant effect of psilocybin and ketamine during the Substance Session (F4, OF4) using the BECK self-rating scale, which will be administered before the administration of the study medication at the beginning of the day and after the administration of the study medication at the end of the day","secondaryObjectiveTranslations":[{"id":12040323,"uuid":"ffa7d609-1635-4dc2-abb4-123a05f8be66","attributeTranslation":"vyhodnocení rychlosti nástupu antidepresivního účinku psilocybinu a ketaminu během Sezení s látkou (F4, OF4) pomocí sebeposuzovací škály BECK, která bude administrována před podáním studijní medikace na začátku dne a po podání studijní medikace na konci dne","language":2,"languageDescription":"Czech"}]},{"id":509428,"number":3,"secondaryObjective":"evaluation of the effect of psilocybin and ketamine (compared to midazolam) on quality of life, well-being and their potential mediators","secondaryObjectiveTranslations":[{"id":12040324,"uuid":"1b31c1b1-96a0-4ad0-8f65-b4c13f357ede","attributeTranslation":"vyhodnocení efektu psilocybinu a ketaminu (ve srovnání s midazolamem) na kvalitu života, well-being a jejich potenciální mediátory","language":2,"languageDescription":"Czech"}]},{"id":509429,"number":4,"secondaryObjective":"evaluating the efficacy of psilocybin and ketamine (compared to midazolam) on nonspecific anxiety","secondaryObjectiveTranslations":[{"id":12040325,"uuid":"c535688f-46cf-4b16-8c6f-0ace2d729344","attributeTranslation":"vyhodnocení účinnosti psilocybinu a ketaminu (ve srovnání s midazolamem) na nespecifickou úzkost","language":2,"languageDescription":"Czech"}]},{"id":509430,"number":5,"secondaryObjective":"the effect of psilocybin and ketamine on the patient subjectively perceived shift in life values ​​and the effect of psilocybin on existential distress including the patient's subjective attitude to life, subjectively perceived hopelessness and demoralization","secondaryObjectiveTranslations":[{"id":12040326,"uuid":"eca63b0c-0c72-40d6-9197-c05f2acbfc72","attributeTranslation":"vliv psilocybinu a ketaminu na pacientem subjektivně vnímaný posun životních hodnot a vliv psilocybinu na existenciální distres zahrnující pacientův subjektivní postoj k životu, subjektivně vnímanou beznaděj a demoralizaci","language":2,"languageDescription":"Czech"}]},{"id":509431,"number":6,"secondaryObjective":"the effect of psilocybin and ketamine on the patient's subjective perception of pain","secondaryObjectiveTranslations":[{"id":12040327,"uuid":"386d3684-f7a1-4237-9e2d-846eeba9cc4b","attributeTranslation":"vliv psilocybinu a ketaminu na pacientovo subjektivní vnímání bolesti","language":2,"languageDescription":"Czech"}]},{"id":509432,"number":7,"secondaryObjective":"evaluation of potential mediators of clinical response","secondaryObjectiveTranslations":[{"id":12040328,"uuid":"8124fe8e-65b0-4c1e-a743-aff876e938d5","attributeTranslation":"vyhodnocení potenciálních mediátorů klinické odpovědi","language":2,"languageDescription":"Czech"}]},{"id":509433,"number":8,"secondaryObjective":"comparison of the antidepressant effect of psilocybin and ketamine depending on the use of standard antidepressants during the clinical trial","secondaryObjectiveTranslations":[{"id":12040329,"uuid":"59ff2498-26f0-4bf2-a711-ae210c8eca2f","attributeTranslation":"srovnání antidepresivního účinku psilocybinu a ketaminu v závislosti na užívání standardních antidepresiv během klinického hodnocení","language":2,"languageDescription":"Czech"}]},{"id":509434,"number":9,"secondaryObjective":"evaluation of the antidepressant effect of psilocybin and ketamine in the open label part of the study","secondaryObjectiveTranslations":[{"id":12040330,"uuid":"829ba74b-c6e5-486a-b7e1-5f22139e94b7","attributeTranslation":"vyhodnocení antidepresivního účinku psilocybinu a ketaminu v otevřené části studie","language":2,"languageDescription":"Czech"}]},{"id":509435,"number":10,"secondaryObjective":"evaluation of the quality of the blinding of the study medication","secondaryObjectiveTranslations":[{"id":12040331,"uuid":"5e33b2ae-d920-4aa0-b917-97a0599810a2","attributeTranslation":"vyhodnocení kvality zaslepení studijní medikace","language":2,"languageDescription":"Czech"}]},{"id":509436,"number":11,"secondaryObjective":"evaluation of the safety and tolerability of psilocybin in patients with comorbid depression","secondaryObjectiveTranslations":[{"id":12040332,"uuid":"4e8081ec-4e3e-4462-b0fe-032180cdc65d","attributeTranslation":"vyhodnocení bezpečnosti a snášenlivosti psilocybinu u pacientů s komorbidní depresí","language":2,"languageDescription":"Czech"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":969704,"number":1,"principalInclusionCriteria":"Men and women aged 18‒75 years","principalInclusionCriteriaTranslations":[{"id":12040314,"uuid":"1bd94a20-ce5f-433f-b7ca-35efaa318d98","attributeTranslation":"Muži a ženy ve věku 18‒75 let","language":2,"languageDescription":"Czech"}]},{"id":969705,"number":2,"principalInclusionCriteria":"A diagnosis meeting diagnostic criteria for a depressive syndrome (F41.2, F32.1, F32.2) comorbid with an oncological disease that: and) is at an advanced stage according to the judgment of the referring oncologist/hematoncologist/internist/paliatrician, or b) is with a poor prognosis (median survival of 5 years or less), or c) currently progressing, or d) shows recurrence, or e) is in the phase of controlled disease, since the oncological dg. at least 6 months have passed, but the patient still has reactive depressive comorbidity","principalInclusionCriteriaTranslations":[{"id":12040315,"uuid":"151776d5-5ab8-4db9-8031-36ee8760f6fb","attributeTranslation":"Diagnóza splňující operacionální diagnostiká kritéria pro depresivní syndrom (F41.2, F32.1, F32.2) komorbidní s onkologickým onemocněním, které:\na)\nje v pokročilém stádiu podle úsudku referujícího onkologa/hematoonkologa/internisty/ paliatra, nebo\nb)\nje se špatnou prognózou (medián přežití 5 a méně let), nebo\nc)\naktuálně progreduje, nebo\nd)\nvykazuje rekurenci, nebo\ne)\nje ve fázi kontrolovaného onemocnění, od stanovení onkologické dg. uběhlo alespoň 6 měsíců, ale pacient stále vykazuje reaktivní depresivní komorbiditu","language":2,"languageDescription":"Czech"}]},{"id":969706,"number":3,"principalInclusionCriteria":"In terms of antidepressant treatment, patients who: a) have not used and do not regularly use any standard antidepressants (SSRI, SNRI NaSSA, SARI, tricyclic and tetracyclic AD), b) are currently using standard antidepressants (SSRI, SNRI NaSSA, SARI, tricyclic and tetracyclic AD) for at least 6 weeks in a stable dose, but the treatment did not provide them with a satisfactory psychological state, c) they underwent psychosocial interventions (counseling, psychotherapy, consultation of the support and palliative team), but these interventions did not provide them with a satisfactory state.","principalInclusionCriteriaTranslations":[{"id":12040316,"uuid":"6e6e1d7e-c3f8-4f4d-a862-ed4f0b9fc837","attributeTranslation":"Z hlediska antidepresivní léčby mohou být zařazeni pacienti, kteří:\na) neužívali a neužívají pravidelně jakákoliv standardní antidepresiva (SSRI, SNRI NaSSA, SARI, tricyklická a tetracyklická AD),b) v současnosti užívají standardní antidepresiva (SSRI, SNRI NaSSA, SARI, tricyklická a tetracyklická AD) alespoň 6 týdnů ve stabilní dávce, ale léčba jim neposkytla uspokojivý psychický stav, c) podstoupili psychosociální intervence (poradenství, psychoterapii, konzultace podpůrného a paliativního týmu), ale tyto intervence jim neposkytly uspokojivý stav.","language":2,"languageDescription":"Czech"}]},{"id":969707,"number":4,"principalInclusionCriteria":"The patient's cognitive ability to fully understand the information about CT and the study questionnaires.","principalInclusionCriteriaTranslations":[{"id":12040317,"uuid":"b1e489f5-d978-42a5-a7fb-243602c4dc0f","attributeTranslation":"Kognitivní zdatnost pacienta umožňující plné porozumění informacím o KH a studijním dotazníkům.","language":2,"languageDescription":"Czech"}]},{"id":969708,"number":5,"principalInclusionCriteria":"Each patient must have a secured caregiver (close relative, relative) who will accompany the patient to the 1st visit, pick up the patient upon discharge after (each) session with the substance (or after discharge from hospitalization) and will be in personal contact with the patient for at least 5 days in week. This caregiver must be available throughout the clinical trial.","principalInclusionCriteriaTranslations":[{"id":12040318,"uuid":"bde189a8-2c4a-4428-b011-dfb9d8e223e8","attributeTranslation":"Každý pacient musí mít zajištěného pečovatele (blízký, příbuzný), který doprovodí pacienta na 1. návštěvu, vyzvedne pacienta při propouštění po (každém) Sezení s látkou (ev. po propuštění z hospitalizace) a bude s pacientem v osobním kontaktu minimálně 5 dní v týdnu. Tento pečovatel musí být k dispozici po celou dobu klinického hodnocení.","language":2,"languageDescription":"Czech"}]},{"id":969709,"number":6,"principalInclusionCriteria":"Participants of childbearing age/preserved fertility must agree to use prescribed methods of contraception and avoid pregnancy for the duration of participation in the clinical trial: a) Women – we require the correct use of at least a barrier contraceptive method (non-hormonal intrauterine device and/or condom and/or vaginal pessary) or sexual abstinence. Hormonal contraception is not required (combined hormonal contraception - in oral, vaginal or transdermal drug form / progestagen hormonal contraception combined with ovulation inhibition - in oral or injectable drug form / intrauterine device), but is accepted if the patient is already using it and it is not contraindicated due to to oncology dg.) b) Men – use of at least an adequate barrier contraceptive method (condom) or sexual abstinence.","principalInclusionCriteriaTranslations":[{"id":12040319,"uuid":"2d98ba06-ed32-4280-87e5-f128bd8635e9","attributeTranslation":"Účastníci v plodném věku/při zachované plodnosti musí souhlasit s používáním předepsaných metod antikoncepce a zabránit otěhotnění po dobu účasti v klinickém hodnocení:\na) Ženy – požadujeme správné používání alespoň bariérové antikoncepční metody (nehormonální nitroděložní tělísko a/nebo kondom a/nebo vaginální pesar) nebo sexuální abstinence. Není požadována hormonální antikoncepce (kombinovaná hormonální antikoncepce - v perorální, vaginální nebo transdermální lékové formě/ gestagenní hormonální antikoncepce spojená s inhibicí ovulace – v perorální nebo injekční lékové formě/ nitroděložní tělísko), ale je akceptovaná, pokud již pacientka užívá a není tato kontraindikována vzhledem k onkologické dg.)\nb) Muži – použití adekvátní alespoň bariérové antikoncepční metody (kondom) nebo sexuální abstinence.","language":2,"languageDescription":"Czech"}]}],"principalExclusionCriteria":[{"id":1654999,"number":1,"principalExclusionCriteria":"Oncological disease with known invasion of the CNS or other serious CNS disease (the exception is asymptomatic CNS involvement in hematological diseases that have been treated with intrathecal cytostatics or radiotherapy). In case of risk of invasion of the underlying disease into the CNS, the patient can only be included in the study if CNS imaging (CT/MR) was performed with negative findings.","principalExclusionCriteriaTranslations":[{"id":12040282,"uuid":"3f7c0aaa-7f5d-4abc-be45-5ebc7e33f95c","attributeTranslation":"Onkologické onemocnění se známou invazí do CNS či jiné závažné onemocnění CNS (výjimku tvoří asymptomatické postižení CNS u hematologických onemocnění, které bylo zaléčeno intrathekálními cytostatiky či radioterapií). V případě rizika invaze základního onemocnění do CNS může být pacient do studie zařazen pouze, pokud bylo provedeno zobrazení CNS (CT/MR) s negativním nálezem.","language":2,"languageDescription":"Czech"}]},{"id":1655000,"number":10,"principalExclusionCriteria":"The patient's condition does not allow compliance with the rules of concomitant treatment (see chapters 6.5 and 6.6 of the protocol)","principalExclusionCriteriaTranslations":[{"id":12040283,"uuid":"556e2d0b-c2bb-4419-9868-b4f6c2ed8206","attributeTranslation":"Pacientův stav neumožňuje dodržení pravidel konkomitantní léčby (viz kapitoly 6.5 a 6.6 protokolu)","language":2,"languageDescription":"Czech"}]},{"id":1655001,"number":11,"principalExclusionCriteria":"Known intolerance or allergy to psilocybin, ketamine, midazolam or other drugs from the benzodiazepine group","principalExclusionCriteriaTranslations":[{"id":12040284,"uuid":"ddc101cd-0341-4753-94d4-8245aea5406e","attributeTranslation":"Známá nesnášenlivost nebo alergie na psilocybin, ketamin, midazolam či jiné léčivo ze skupiny benzodiazepinů","language":2,"languageDescription":"Czech"}]},{"id":1655002,"number":12,"principalExclusionCriteria":"Pregnancy or breastfeeding","principalExclusionCriteriaTranslations":[{"id":12040285,"uuid":"8b0cd719-c4e4-4b5b-8a4b-5041c3ee9367","attributeTranslation":"Těhotenství či kojení","language":2,"languageDescription":"Czech"}]},{"id":1655003,"number":13,"principalExclusionCriteria":"Liver dysfunction with GGT, AST, ALT values ​​> 5x upper limit of normal, total bilirubin > 50 μmol/l","principalExclusionCriteriaTranslations":[{"id":12040286,"uuid":"7ea50dff-3499-440e-8de6-fd1f2f70f299","attributeTranslation":"Jaterní dysfunkce s hodnotami GGT, AST, ALT > 5x horní hranice normy, celkový bilirubin > 50 μmol/l","language":2,"languageDescription":"Czech"}]},{"id":1655004,"number":14,"principalExclusionCriteria":"Cardiovascular instability in the sense of uncorrected hypertension (initial BP values ​​≥ 140/90 mm Hg – average value of 3 measurements), angina pectoris, heart failure or pre-existing clinically significant changes in the ECG (significant conduction disturbances, significant arrhythmias) or tachycardia (initial values ​​≥ 100 beats/min – average value from 3 measurements)","principalExclusionCriteriaTranslations":[{"id":12040287,"uuid":"cf4be51b-4fbb-4fdc-a509-0f37f075976b","attributeTranslation":"Kardiovaskulární instabilita ve smyslu nekorigované hypertenze (vstupní hodnoty TK ≥ 140/90 mm Hg – průměrná hodnota ze 3 měření), anginy pectoris, srdečního selhání nebo preexistujících klinicky významných změn v EKG (významné převodní poruchy, významné arytmie) či tachykardie (vstupní hodnoty ≥ 100 tepů/min – průměrná hodnota ze 3 měření)","language":2,"languageDescription":"Czech"}]},{"id":1655005,"number":15,"principalExclusionCriteria":"Myasthenia gravis","principalExclusionCriteriaTranslations":[{"id":12040288,"uuid":"9ebc1854-0d06-4f21-9b2c-86dddb68b660","attributeTranslation":"Myasthenia gravis","language":2,"languageDescription":"Czech"}]},{"id":1655006,"number":16,"principalExclusionCriteria":"Epilepsy incl. history of isolated epileptic seizures","principalExclusionCriteriaTranslations":[{"id":12040289,"uuid":"6d8ed7fc-699b-46dc-a2f6-fefe87bc4592","attributeTranslation":"Epilepsie vč. anamnézy ojedinělých epileptických záchvatů","language":2,"languageDescription":"Czech"}]},{"id":1655007,"number":17,"principalExclusionCriteria":"Renal insufficiency with a GFR value of less than 0.66 ml/s/1.73 m2 according to CKD-EPI (creatinine)","principalExclusionCriteriaTranslations":[{"id":12040290,"uuid":"b75f1064-6906-46d5-a662-163700a8d390","attributeTranslation":"Renální insuficience s hodnotou GFR méně než 0,66 ml/s/1.73 m2 dle CKD-EPI (kreatinin)","language":2,"languageDescription":"Czech"}]},{"id":1655008,"number":18,"principalExclusionCriteria":"Known paraneoplastic syndrome or ectopic production of hormones by the primary tumor, within which hypercalcemia, Cushing's syndrome, hypoglycemia, SIADH or carcinoid syndrome could occur","principalExclusionCriteriaTranslations":[{"id":12040291,"uuid":"c50a0963-c3e7-4a76-9f37-9978e68562ee","attributeTranslation":"Známý paraneoplastický syndrom či ektopická produkce hormonů primárním tumorem, v rámci kterého by mohlo dojít k hyperkalcemii, Cushingově syndromu, hypoglykemii, SIADH či karcinoidovému syndromu","language":2,"languageDescription":"Czech"}]},{"id":1655009,"number":19,"principalExclusionCriteria":"Diabetes mellitus on insulin or corrected with oral antidiabetic drugs, if there is a history of clinically significant hypoglycemia","principalExclusionCriteriaTranslations":[{"id":12040292,"uuid":"dd7f5f54-0ff1-40fd-9fbf-c2678aeed1a3","attributeTranslation":"Diabetes mellitus na inzulinu nebo korigovaný perorálními antidiabetiky, pokud se v anamnéze vyskytla klinicky významná hypoglykemie","language":2,"languageDescription":"Czech"}]},{"id":1655010,"number":2,"principalExclusionCriteria":"Myocardial infarction less than 6 months ago","principalExclusionCriteriaTranslations":[{"id":12040293,"uuid":"fecfdd3c-a3a4-4f5f-a768-70f299abd4a1","attributeTranslation":"Prodělaný infarkt myokardu před méně než 6 měsíci","language":2,"languageDescription":"Czech"}]},{"id":1655011,"number":20,"principalExclusionCriteria":"Glaucoma","principalExclusionCriteriaTranslations":[{"id":12040294,"uuid":"cfc2efc9-6dfb-4e85-8840-296740c66583","attributeTranslation":"Glaukom","language":2,"languageDescription":"Czech"}]},{"id":1655012,"number":21,"principalExclusionCriteria":"Untreated or imperfectly compensated hyperthyroidism","principalExclusionCriteriaTranslations":[{"id":12040295,"uuid":"b2d201fc-63f2-4c35-85ed-a391739670c0","attributeTranslation":"Neléčená nebo nedokonale kompenzovaná hyperthyreóza","language":2,"languageDescription":"Czech"}]},{"id":1655013,"number":22,"principalExclusionCriteria":"Any current or anamnestic psychotic illness from the range of diagnoses F2x.x","principalExclusionCriteriaTranslations":[{"id":12040296,"uuid":"d8c2a9f6-5f7e-4e02-8cd3-6a90549d1c12","attributeTranslation":"Jakékoliv psychotické onemocnění současné nebo anamnestické z okruhu diagnóz F2x.x","language":2,"languageDescription":"Czech"}]},{"id":1655014,"number":23,"principalExclusionCriteria":"Current or anamnestic bipolar affective disorder F31.x and manic phase F30.x","principalExclusionCriteriaTranslations":[{"id":12040297,"uuid":"bd53d195-b4a2-4554-a194-200639833a3b","attributeTranslation":"Současná nebo anamnestická bipolární afektivní porucha F31.x a manická fáze F30.x","language":2,"languageDescription":"Czech"}]},{"id":1655015,"number":24,"principalExclusionCriteria":"Current major depressive episode with psychotic symptoms F32.3 and F33.3","principalExclusionCriteriaTranslations":[{"id":12040298,"uuid":"6d5fb93e-9671-449c-97c0-62338c16d5fc","attributeTranslation":"Současná těžká depresivní epizoda s psychotickými příznaky F32.3 a F33.3","language":2,"languageDescription":"Czech"}]},{"id":1655016,"number":25,"principalExclusionCriteria":"Presence of suicidal ideation/behavior on the C-SSRS Lifetime/Recent (L/R) version (specifically, a “yes” answer to question 5 in the past 1 month and/or any “yes” answer to the suicidal behavior questions in the past 3 months) and /or based on clinical examination","principalExclusionCriteriaTranslations":[{"id":12040299,"uuid":"30bd9057-ba29-4484-b22f-01b896fa654e","attributeTranslation":"Přítomnost sebevražedných představ/chování na základě C-SSRS verze Lifetime/Recent (L/R) (konkrétně odpověd „ano“ na otázku 5 v minulém 1 měsíci a/nebo jakákoliv odpověď „ano“ na otázky sebevražedného chování v minulých 3 měsících) a/nebo na základě klinického vyšetření","language":2,"languageDescription":"Czech"}]},{"id":1655017,"number":26,"principalExclusionCriteria":"Organic mental disorders including symptomatic F00.x-F09.x","principalExclusionCriteriaTranslations":[{"id":12040300,"uuid":"a9ed77c4-a02e-4f10-9fc3-76ee6e2ad25a","attributeTranslation":"Organické duševní poruchy včetně symptomatických F00.x-F09.x","language":2,"languageDescription":"Czech"}]},{"id":1655018,"number":27,"principalExclusionCriteria":"Psychotic disorders caused by the use of addictive substances (F10.x – F19.x), dissociative disorder (F44.x), eating disorders (F50.x), emotionally unstable, or borderline disorder (F60.3)","principalExclusionCriteriaTranslations":[{"id":12040301,"uuid":"83b47d4f-06c8-4447-bdfa-1b99698d2e30","attributeTranslation":"Psychotické poruchy způsobené užíváním návykových látek (F10.x – F19.x), disociativní porucha (F44.x), poruchy příjmu potravy (F50.x), emočně nestabilní, resp. hraniční porucha (F60.3)","language":2,"languageDescription":"Czech"}]},{"id":1655019,"number":28,"principalExclusionCriteria":"Current or anamnestic alcohol or drug addiction F1x.x. (except opioids and medicinal cannabis used in accordance with the controlled treatment of the underlying disease), if abstinence for at least 2 years cannot be proven","principalExclusionCriteriaTranslations":[{"id":12040302,"uuid":"f15f147c-0b47-46c3-9026-2f3c41faac8f","attributeTranslation":"Současná nebo anamnestická alkoholová nebo drogová závislost F1x.x. (kromě opioidů a léčebného konopí užívaných v souladu s řízenu léčbou základního onemocnění), pokud nelze prokázat alespoň 2 roky abstinenci","language":2,"languageDescription":"Czech"}]},{"id":1655020,"number":29,"principalExclusionCriteria":"Undergoing electroconvulsive therapy less than 3 months ago","principalExclusionCriteriaTranslations":[{"id":12040303,"uuid":"6be5a69e-12dc-48bd-ac28-cafe0cd4dce4","attributeTranslation":"Prodělání elektrokonvulzivní terapie před méně než 3 měsíci","language":2,"languageDescription":"Czech"}]},{"id":1655021,"number":3,"principalExclusionCriteria":"A stroke and/or TIA less than 6 months ago","principalExclusionCriteriaTranslations":[{"id":12040304,"uuid":"59df9509-f3b8-4626-942e-a4c91a533cb3","attributeTranslation":"Prodělaná cévní mozková příhoda a/nebo TIA před méně než 6 měsíci","language":2,"languageDescription":"Czech"}]},{"id":1655022,"number":30,"principalExclusionCriteria":"First-degree relative of a patient suffering from schizophrenia, other psychotic disorder (unless caused by a substance or medical condition)","principalExclusionCriteriaTranslations":[{"id":12040305,"uuid":"836841ca-d074-4d02-a871-9f3115f57827","attributeTranslation":"Příbuzný pacienta I. řádu, který trpí schizofrenií, jinou psychotickou poruchou (pokud nebyla vyvolána látkou nebo zdravotním stavem)","language":2,"languageDescription":"Czech"}]},{"id":1655023,"number":31,"principalExclusionCriteria":"Inappropriateness of patient inclusion based on the clinical judgment of the examining physician","principalExclusionCriteriaTranslations":[{"id":12040306,"uuid":"971dc84e-435c-4139-9767-0fc8bc0bb104","attributeTranslation":"Nevhodnost zařazení pacienta na základě klinického úsudku zkoušejícího lékaře","language":2,"languageDescription":"Czech"}]},{"id":1655024,"number":4,"principalExclusionCriteria":"Clinically significant peripheral vascular diseases (acute venous thrombosis, chronic venous insufficiency in the stage of leg ulcers, ischemic disease of the lower limbs in the stage of claudication)","principalExclusionCriteriaTranslations":[{"id":12040307,"uuid":"1569526d-a914-4f54-a469-ab7da74f9594","attributeTranslation":"Klinicky významná periferní vaskulární onemocnění (akutní žilní trombóza, chronická žilní insuficience ve stádiu bércových vředů, ischemická choroba dolních končetin ve stádiu klaudikací)","language":2,"languageDescription":"Czech"}]},{"id":1655025,"number":5,"principalExclusionCriteria":"Dyspnea of ​​any etiology higher than NYHA II, acute respiratory failure or severe respiratory insufficiency, sleep apnea syndrome","principalExclusionCriteriaTranslations":[{"id":12040308,"uuid":"76fa5e2f-68e4-4586-94bc-fb718807186d","attributeTranslation":"Dušnost jakékoliv etiologie vyššího stupně než NYHA II, akutní respirační selhání nebo těžká respirační insuficience, syndrom spánkové apnoe","language":2,"languageDescription":"Czech"}]},{"id":1655026,"number":6,"principalExclusionCriteria":"Severe thrombocytopenia < 30 x 10 9/l, resistant to substitution","principalExclusionCriteriaTranslations":[{"id":12040309,"uuid":"299c2a66-2a0e-4428-8459-a43ba292184c","attributeTranslation":"Těžká trombocytopenie < 30 x 10 9/l, rezistentní na substituci","language":2,"languageDescription":"Czech"}]},{"id":1655027,"number":7,"principalExclusionCriteria":"Neurological foci findings","principalExclusionCriteriaTranslations":[{"id":12040310,"uuid":"df511a2b-2703-4225-adae-67e2c595802f","attributeTranslation":"Ložiskový neurologický nález","language":2,"languageDescription":"Czech"}]},{"id":1655028,"number":8,"principalExclusionCriteria":"Impossibility of oral administration of the study medication in the form of capsules","principalExclusionCriteriaTranslations":[{"id":12040311,"uuid":"9ba066c3-6cff-464c-bca2-bc6b7ab48928","attributeTranslation":"Nemožnost perorálního podání studijní medikace ve formě tobolek","language":2,"languageDescription":"Czech"}]},{"id":1655029,"number":9,"principalExclusionCriteria":"Estimated patient survival time less than 4 months","principalExclusionCriteriaTranslations":[{"id":12040312,"uuid":"8e36b060-300e-4db7-a355-7978aedec7f7","attributeTranslation":"Předpokládaná doba přežití pacienta méně než 4 měsíce","language":2,"languageDescription":"Czech"}]}]},"endPoint":{"primaryEndPoints":[{"id":1133703,"number":1,"endPoint":"The effectiveness of psilocybin will be evaluated by comparison with the antidepressant ketamine and midazolam using the MADRS scale. Response and remission will be evaluated. Baseline is defined as the score obtained at Preparation Session 1 (9 - 7 days) prior to study medication administration. Response is defined as ≥ 50% reduction in MADRS total score from baseline, and remission is defined as ≤10 MADRS","isPrimary":true,"endPointTranslations":[{"id":12040270,"uuid":"cf40b467-bf55-4f25-9f21-65ef08f5f568","attributeTranslation":"Účinnost psilocybinu (aktivní látka 1) bude hodnocena srovnáním s antidepresivně působícím ketaminem (aktivní látka 2) a midazolamem (kontrolní přípravek, bez antidepresivního účinku) pomocí škály MADRS. Hodnocena bude odpověď a remise. Baseline je definován jako skóre získané na Přípravném setkání 1 (9 - 7 dní) před podáním studijní medikace. Odpověď „response“ je definovaná jako ≥ 50% redukce celkového skóre ve stupnici MADRS oproti baseline a remise je definovaná jako ≤10 ve stupnici MADRS","language":2,"languageDescription":"Czech"}]}],"secondaryEndPoints":[{"id":1133704,"number":1,"endPoint":"The rate of onset and duration of substance use will be assessed using the MADRS objective scale and the BECK self-report scale as change scores on day 1, day 4, 1 week (day 7), 4 weeks (day 28), 8 weeks (day 56 ), 16 weeks (day 112) and 24 weeks (day 224) from administration of study medication compared to baseline.","isPrimary":false,"endPointTranslations":[{"id":12040271,"uuid":"135fab25-c3a7-41e6-98c1-e17fd5f63d20","attributeTranslation":"Rychlost nástupu a délky trvání použitých látek bude hodnocena pomocí objektivní škály MADRS a sebeposuzovací škály BECK jako změna skóre 1. den, 4. den, 1 týden (7. den), 4 týdny (28. den), 8 týdnů (56. den), 16 týdnů (112. den) a 24 týdnů (224. den) od podání studijní medikace oproti baseline.","language":2,"languageDescription":"Czech"}]},{"id":1133705,"number":2,"endPoint":"The BECK self-rating scale, which is administered before the administration of the study medication at the beginning of the day and after the administration of the study medication at the end of the day","isPrimary":false,"endPointTranslations":[{"id":12040272,"uuid":"45b6b503-d040-4efd-8974-88a8b13c4b66","attributeTranslation":"Sebeposuzovací škála BECK, která je administrována před podáním studijní medikace na začátku dne a po podání studijní medikace na konci dne","language":2,"languageDescription":"Czech"}]},{"id":1133706,"number":3,"endPoint":"The effect of psilocybin and ketamine on the patient's subjectively perceived quality of life and well-being will be assessed as a change in the score on the FACIT scale and its sub-scales 1 week (day 7), 4 weeks (day 28) and 24 weeks (day 224) from administration of study medication versus baseline.","isPrimary":false,"endPointTranslations":[{"id":12040273,"uuid":"f9af9793-5869-4cd6-b110-82bfdcad310c","attributeTranslation":"Vliv psilocybinu a ketaminu na pacientem subjektivně vnímanou kvalitu života a well-being bude posuzován jako změna skóre na škále FACIT a jejích sub-škálách 1 týden (7. den), 4 týdny (28. den) a 24 týdnů (224. den) od podání studijní medikace oproti baseline.","language":2,"languageDescription":"Czech"}]},{"id":1133707,"number":4,"endPoint":"Efficacy will be assessed as change in HAM-A objective scale and STAI self-report scores at day 1, day 4, 1 week (day 7), 4 weeks (day 28), 8 weeks (day 56), 16. weeks (112th day) and 24 weeks (224th day) from administration of study medication compared to baseline.","isPrimary":false,"endPointTranslations":[{"id":12040274,"uuid":"3cac438d-31e2-451b-9d94-9960fd85eecf","attributeTranslation":"Účinnost bude posuzována jako změna skóre na objektivní škále HAM-A a sebeposuzovací škále STAI 1. den, 4. den, 1 týden (7. den), 4 týdny (28. den), 8 týdnů (56. den), 16. týdnů (112. den) a 24 týdnů (224. den) od podání studijní medikace oproti baseline.","language":2,"languageDescription":"Czech"}]},{"id":1133708,"number":5,"endPoint":"PEQ scale will be assessed 4 weeks (day 28) and 24 weeks (day 224) after administration of the study medication and will be evaluated as a change from baseline. The effect of psilocybin on existential distress including patients' subjective attitude towards life (LAP-R), subjectively perceived hopelessness (HAI) and demoralization (DS) will be assessed as change in scores on the respective scales at 1 week (day 7), 4 weeks (day 28 ) and 24 weeks (day 224) from administration of study medication.","isPrimary":false,"endPointTranslations":[{"id":12040275,"uuid":"894c14f4-542e-428c-9743-ec13d9cf8ac4","attributeTranslation":"Škála PEQ bude posuzován 4 týdny (28. den) a 24 týdnů (224. den) od podání studijní medikace a bude hodnocen jako změna oproti baseline. Vliv psilocybinu na existenciální distres zahrnující pacientův subjektivní postoj k životu (LAP-R), subjektivně vnímanou beznaděj (HAI) a demoralizaci (DS) bude posuzován jako změna skóre na příslušných škálách 1 týden (7. den), 4 týdny (28. den) a 24 týdnů (224. den) od podání studijní medikace oproti baseline.","language":2,"languageDescription":"Czech"}]},{"id":1133709,"number":6,"endPoint":"This effect will be monitored using a pain visual analogue scale (VAS) at day 1, 1 week (day 7), 4 weeks (day 28) and 24 weeks (day 224) of study medication administration versus baseline.","isPrimary":false,"endPointTranslations":[{"id":12040276,"uuid":"75a672a1-25b4-4952-9fb7-c359e1a95be0","attributeTranslation":"Tento vliv bude sledován pomocí vizuální analogové škály bolesti (VAS) 1. den, 1 týden (7. den), 4 týdny (28. den) a 24 týdnů (224. den) od podání studijní medikace oproti baseline.","language":2,"languageDescription":"Czech"}]},{"id":1133710,"number":7,"endPoint":"Evaluation of the antidepressant effect of psilocybin and ketamine depending on the intensity of acute psychological effects during a session with the substance. Acute effects will be assessed by the patient at the end of the day after each session with psilocybin, ketamine and midazolam using the subjective 5D-ASCs and MEQ scales, which reflect the main psychological dimensions of intoxication affecting therapeutic antidepressant response.","isPrimary":false,"endPointTranslations":[{"id":12040277,"uuid":"3e3ba28e-b1d7-4826-b091-5e70abf0a68a","attributeTranslation":"Zhodnocení antidepresivního účinku psilocybinu a ketaminu v závislosti na intenzitě akutních psychologických účinků v průběhu sezení s látkou. Akutní účinky budou hodnoceny pacientem na konci dne po každém sezení s látkou psilocybinem, ketaminem a midazolamem pomocí subjektivních škál 5D-ASCs a MEQ, které odrážejí hlavní psychologické dimenze intoxikace ovlivňující terapeutickou antidepresivní odpověď.","language":2,"languageDescription":"Czech"}]},{"id":1133711,"number":8,"endPoint":"The antidepressant effect will be compared in patients taking standard antidepressants during the clinical trial (AD-plus group) versus a group of patients not taking antidepressants (AD-free). We hypothesize that the clinical effect of psilocybin will be more pronounced in the AD-plus group than in the AD-free group.","isPrimary":false,"endPointTranslations":[{"id":12040278,"uuid":"0381fe78-e474-4426-a9c7-0b66ce336028","attributeTranslation":"Bude porovnán antidepresivní efekt u pacientů užívajících standardní antidepresiva během klinického hodnocení (skupina AD-plus) oproti skupině pacientů, kteří antidepresiva neužívají (AD-free). Předpokládáme, že klinický efekt psilocybinu bude výraznější ve skupině AD-plus než AD-free.","language":2,"languageDescription":"Czech"}]},{"id":1133712,"number":9,"endPoint":"Evaluation of the antidepressant effect in the open-label part of the study will correspond to the primary (2.2), secondary (2.3) and exploratory (2.3) objectives, with the evaluation not being blinded and only psilocybin and ketamine being compared (midazolam will not be administered).","isPrimary":false,"endPointTranslations":[{"id":12040279,"uuid":"b1e74432-ca45-459d-8584-2e4bd34dc543","attributeTranslation":"Hodnocení antidepresivního účinku v otevřené části studie bude odpovídat primárním (2.2), sekundárním (2.3) a průzkumným (2.3) cílům s tím, že hodnocení nebude zaslepené a porovnáván bude pouze psilocybin a ketamin (midazolam nebude aplikován).","language":2,"languageDescription":"Czech"}]},{"id":1133713,"number":10,"endPoint":"The quality of the blinding of the study medication in the double-blind part of the study will be monitored using the BQQ Questionnaire. The estimate of administered study medication will be determined independently of the participant, therapist and co-therapist. The questionnaire will be filled in 4 weeks (day 28) from the administration of the study medication, at the end of Integration Session 3 after evaluation by an independent evaluator.","isPrimary":false,"endPointTranslations":[{"id":12040280,"uuid":"dbfc96c7-56d7-4e0d-b652-e0e42c16d7db","attributeTranslation":"Kvalita zaslepení studijní medikace v dvojitě-zaslepené části studie bude sledována pomocí Dotazníku BQQ. Bude zjištován odhad podané studijní medikace nezávisle od účastníka, terapeuta i ko-terapeuta. Dotazník bude vyplněn za 4 týdny (28.den) od podání studijní medikace, na konci Integračního sezení 3 po evaluaci nezávislým hodnotitelem.","language":2,"languageDescription":"Czech"}]},{"id":1133714,"number":11,"endPoint":"Safety will be assessed by changes in vital signs (blood pressure [BP], heart rate [TF]) during drug sessions, the BPRS scale, and suicidal ideation/behavior scores assessed by the C-SSRS, version Since Last Visit (SLV) at the end of the session with the substance, based on monitoring the incidence of adverse events throughout the study and further evaluating the persistent psychotropic effects of psilocybin using the PSQ scale 1 day after administration of the study medication.","isPrimary":false,"endPointTranslations":[{"id":12040281,"uuid":"ab2c533e-07d0-4085-a6e1-49463dbfc5ea","attributeTranslation":"Bezpečnost bude hodnocena pomocí změn vitálních funkcí (krevní tlak [TK], tepová frekvence [TF]) v průběhu sezení s látkou, škály BPRS a skóre sebevražedného myšlení/chování hodnoceného pomocí C-SSRS, verze Since Last Visit (SLV) na konci sezení s látkou, na základě sledování incidence nežádoucích příhod v průběhu celé studie a dále zhodnocením přetrvávajících psychotropních účinků psilocybinu pomocí škály PSQ 1 den po podání studijní medikace.","language":2,"languageDescription":"Czech"}]}]},"trialDuration":{"estimatedEndDate":"2026-07-01","estimatedRecruitmentStartDate":"2022-07-22"},"sourceOfMonetarySupport":[{"id":104849,"organisationName":"Academic clinical trial is financially supported by grants and the sponsor organization"}],"populationOfTrialSubjects":{"ageRanges":[{"id":391016,"ageRangeCategoryCode":"3","ageRangeCategory":"3"},{"id":391017,"ageRangeCategoryCode":"4","ageRangeCategory":"4"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":true},"individualParticipantData":{"planToShareIPD":"1"}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-09-22","conclusionDate":"2026-09-22","therapeuticAreas":[{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"}],"medicalConditions":[{"id":149126,"medicalCondition":"Depressive disorder comorbid with cancer","isConditionRareDisease":false}],"sponsors":[{"id":162198,"primary":true,"publicContacts":[{"id":478785,"type":"Public","functionalName":"Nikola Leca","functionalEmailAddress":"nikola.leca@nudz.cz","telephone":"+420777485446","organisation":{"id":612568,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Narodni Ustav Dusevniho Zdravi","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100044300","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":478786,"type":"Scientific","functionalName":"Jiří Horáček","functionalEmailAddress":"jiri.horacek@nudz.cz","telephone":"+420283088412","organisation":{"id":612568,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Narodni Ustav Dusevniho 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