{"ctNumber":"2025-521488-11-00","ctStatus":"Authorised","decisionDate":"2026-06-22T14:06:07.208","publishDate":"2026-06-23T03:33:35.704193371","ctPublicStatusCode":2,"authorizedApplication":{"authorizedPartI":{"id":132821,"rowSubjectCount":0,"products":[{"id":551545,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"13358336","productPharmForm":"CAPSULE","euMpNumber":"PRD13358336","prodAuthStatus":1,"prodName":"PEX010 Psilocybin Capsules (25 mg Psilocybin)","pharmForm":"CAPSULE","activeSubstanceName":"DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: METHANOL","euSubstNumber":"SUB267722","nameOrg":"ARQ NATIONAAL PSYCHOTRAUMA CENTRUM","productSubstances":[{"productPk":"13358336","substancePk":"377754","nameOrg":"ARQ NATIONAAL PSYCHOTRAUMA CENTRUM","substanceOrigin":"Specified Substance Group 1","actSubstOrigin":"Specified Substance Group 1","actSubstName":"DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: 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behandelingssessies.","language":18,"languageDescription":"Dutch"}]},{"id":900479,"number":5,"principalInclusionCriteria":"Is a veteran of the Dutch Armed Forces.","principalInclusionCriteriaTranslations":[{"id":11115376,"uuid":"cd3e36dd-3b5a-43c1-93b1-eb6c872b0694","attributeTranslation":"Deelnemer is een veteraan van de Nederlandse krijgsmacht.","language":18,"languageDescription":"Dutch"}]}],"principalExclusionCriteria":[{"id":1540095,"number":1,"principalExclusionCriteria":"Have current cluster A- or B personality disorders.","principalExclusionCriteriaTranslations":[{"id":11115360,"uuid":"1eb8998d-5c8e-4558-8827-0aac60beb1eb","attributeTranslation":"Deelnemer heeft een huidige cluster A- of B-persoonlijkheidsstoornissen.","language":18,"languageDescription":"Dutch"}]},{"id":1540096,"number":10,"principalExclusionCriteria":"Have uncontrolled severe hypertension, defined as confirmed (repeat office and/or out-of-office) blood pressure consistent with grade 2–3 hypertension (office systolic ≥160 mmHg and/or diastolic ≥100 mmHg), or grade 1 hypertension in combination with other cardiovascular risk factors, resulting in an increased cardiovascular risk profile according to the 2023 European Society of Hypertension (ESH) guideline risk stratification. Blood pressure status may be confirmed by repeated clinic measurements or home/ambulatory blood pressure monitoring if clinically indicated. Participants with well-controlled hypertension that has been successfully treated with anti-hypertensive medicines may be enrolled.","principalExclusionCriteriaTranslations":[{"id":11115361,"uuid":"06b012d7-2612-4dad-9e4d-df2c6ea581b7","attributeTranslation":"Heeft een diagnose van ongecontroleerde ernstige hypertensie, gedefinieerd als bevestigde (herhaalde metingen in de spreekkamer en/of daarbuiten) bloeddruk die overeenkomt met graad 2–3 hypertensie (spreekkamer systolisch ≥160 mmHg en/of diastolisch ≥100 mmHg), of graad 1 hypertensie in combinatie met andere cardiovasculaire risicofactoren, resulterend in een verhoogd cardiovasculair risicoprofiel volgens de risicostratificatie van de European Society of Hypertension (ESH) richtlijn uit 2023. De bloeddrukstatus kan worden bevestigd door herhaalde metingen in de kliniek of door thuis- of ambulante bloeddrukmonitoring indien klinisch geïndiceerd. Deelnemers met goed gecontroleerde hypertensie die succesvol behandeld zijn met antihypertensieve medicatie kunnen worden geïncludeerd.","language":18,"languageDescription":"Dutch"}]},{"id":1540097,"number":11,"principalExclusionCriteria":"Have a history of any medical condition that could make receiving a psilocybin harmful because of temporary increases in blood pressure and heart rate. This includes, but is not limited to cerebrovascular accident, heart failure, or unstable insulin-dependent diabetes.","principalExclusionCriteriaTranslations":[{"id":11115362,"uuid":"5237aa7a-98f8-4a71-bbce-36f94d7a759c","attributeTranslation":"Heeft in de voorgeschiedenis een medische aandoening die het nemen van psilocybine schadelijk zou kunnen maken vanwege een tijdelijke verhoging van de bloeddruk en hartslag. Dit omvat, maar is niet beperkt tot, cerebrovasculair accident, hartfalen of instabiele insuline-afhankelijke diabetes.","language":18,"languageDescription":"Dutch"}]},{"id":1540098,"number":2,"principalExclusionCriteria":"Have a history of, or a current primary psychotic disorder, bipolar disorder type 1, or major depressive disorder with psychotic features.","principalExclusionCriteriaTranslations":[{"id":11115363,"uuid":"c6a3cbad-801f-427c-a830-971a88638da9","attributeTranslation":"Heeft een voorgeschiedenis van, of een huidige primaire psychotische stoornis, bipolaire stoornis type 1, of major depressieve stoornis met psychotische kenmerken.","language":18,"languageDescription":"Dutch"}]},{"id":1540099,"number":3,"principalExclusionCriteria":"Has a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I disorder.","principalExclusionCriteriaTranslations":[{"id":11115364,"uuid":"c5e6009b-cf04-4fc3-8ce4-7bd60556eba1","attributeTranslation":"Heeft een eerstegraads familielid met schizofrenie, een psychotische stoornis (tenzij veroorzaakt door drugs of als gevolg van een medische aandoening) of een bipolaire stoornis.","language":18,"languageDescription":"Dutch"}]},{"id":1540100,"number":4,"principalExclusionCriteria":"Have current anorexia nervosa or bulimia nervosa.","principalExclusionCriteriaTranslations":[{"id":11115365,"uuid":"a5021be7-7b4f-4024-b907-36a9171a2f52","attributeTranslation":"Heeft huidige anorexia nervosa of boulimia nervosa.","language":18,"languageDescription":"Dutch"}]},{"id":1540101,"number":5,"principalExclusionCriteria":"Have current dissociative identity disorder.","principalExclusionCriteriaTranslations":[{"id":11115366,"uuid":"43a7c1d5-120c-441f-9b35-d074e1545def","attributeTranslation":"Heeft huidige dissociatieve identiteitsstoornis.","language":18,"languageDescription":"Dutch"}]},{"id":1540102,"number":6,"principalExclusionCriteria":"Have a current: a) Severe alcohol or cannabis use disorder (meets at least 6 of 11 diagnostic criteria per DSM-5) within the 12 months prior to enrollment; b) Moderate alcohol or cannabis use disorder (4 or 5 of 11 diagnostic criteria per DSM-5) within the 12 months prior to enrollment, unless in early remission (i.e., at least 3 months without symptoms, with the exceptions of possible craving/urge to use); Mild alcohol or cannabis use disorder is not an exclusion criterion (2 or 3 of 11 diagnostic criteria per DSM-5).","principalExclusionCriteriaTranslations":[{"id":11115367,"uuid":"110396f2-6650-435d-ae5a-2dbe1c81cff6","attributeTranslation":"Heeft een huidige: a) Ernstige stoornis in het gebruik van alcohol of cannabis (voldoet aan ten minste 6 van de 11 diagnostische criteria volgens de DSM-5) binnen de 12 maanden voorafgaand aan de inschrijving; b) Matige stoornis in het gebruik van alcohol of cannabis (4 of 5 van de 11 diagnostische criteria volgens de DSM-5) binnen de 12 maanden voorafgaand aan de inschrijving, tenzij in vroege remissie (d.w.z., ten minste 3 maanden zonder symptomen, met uitzondering van mogelijke hunkering naar gebruik); een lichte stoornis in het gebruik van alcohol of cannabis is geen exclusiecriterium (2 of 3 van de 11 diagnostische criteria volgens de DSM-5).","language":18,"languageDescription":"Dutch"}]},{"id":1540103,"number":7,"principalExclusionCriteria":"Have an illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.","principalExclusionCriteriaTranslations":[{"id":11115368,"uuid":"b933056e-4364-431d-9c66-6e76ddd7dce3","attributeTranslation":"Heeft een stoornis in het gebruik van illegale drugs (anders dan cannabis) of drugs op recept in welke ernst dan ook binnen 12 maanden voorafgaand aan enrollment.","language":18,"languageDescription":"Dutch"}]},{"id":1540104,"number":8,"principalExclusionCriteria":"Any participant presenting current serious suicide risk, as determined through screening interview, responses to C-SSRS, and clinical judgment will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior will not be enrolled. Any participant presenting with the following on the baseline/screening C-SSRS will be excluded: a) Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more. b) Suicidal ideation score of 5 within the last 6 months of the assessment. c) Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self-injurious behavior may be included if approved by the study physician.","principalExclusionCriteriaTranslations":[{"id":11115369,"uuid":"07a88e1d-ad64-4a1d-8b71-428dab167ad2","attributeTranslation":"Elke deelnemer met een actueel ernstig suïciderisico, zoals bepaald door middel van het screeningsinterview, de antwoorden op de C-SRS en klinisch oordeel, wordt geëxcludeerd; een voorgeschiedenis van suïcidepogingen is echter geen reden tot exclusie. Elke deelnemer die waarschijnlijk een ziekenhuisopname nodig heeft in verband met suïcidale gedachten en suïcidaal gedrag wordt niet geïncludeerd. Elke deelnemer die de volgende symptomen vertoont op de baseline/screening C-SRS wordt uitgesloten: a) Suïcidale ideatiescore van 4 of hoger binnen de laatste maand van de beoordeling met een frequentie van één keer per week of meer. b) Suïcidale ideatiescore van 5 binnen de laatste 6 maanden van de beoordeling. c) Enig suïcidaal gedrag, inclusief suïcidepogingen of voorbereidende handelingen, binnen de laatste 6 maanden van de beoordeling. Deelnemers met niet suïcidaal zelfverwondend gedrag kunnen worden geïncludeerd indien goedgekeurd door de studiearts.","language":18,"languageDescription":"Dutch"}]},{"id":1540105,"number":9,"principalExclusionCriteria":"Have a current history of one of the following cardiovascular conditions: a) coronary artery disease, congenital long QT syndrome (prior diagnosis), cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction (prior diagnosis); b) tachycardia (defined as heart rate > 100 beats per minute); c) clinically significant Screening ECG abnormality (including, but not limited to, atrial fibrillation, Wolff-Parkinson-White syndrome, ventricular tachycardia), Note: A QTcF interval > 450 milliseconds is considered a clinically significant ECG abnormality; d) artificial heart valve; e) additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); f) any other significant current or history of cardiovascular condition, based on the clinical judgment of the study physician, that would make a participant unsuitable for the study.","principalExclusionCriteriaTranslations":[{"id":11115370,"uuid":"70c2fd4a-da4f-4890-a831-ca880fe44d08","attributeTranslation":"Heeft in de voorgeschiedenis een van de volgende cardiovasculaire aandoeningen: a) coronaire hartziekte, congenitaal lang QT-syndroom (eerdere diagnose), cardiale hypertrofie, cardiale ischemie, congestief hartfalen, myocardinfarct (eerdere diagnose); b) tachycardie (gedefinieerd als hartslag > 100 slagen per minuut); c) klinisch significante Screening ECG-afwijking (inclusief, maar niet beperkt tot, atriumfibrillatie, Wolff-Parkinson-White syndroom, ventriculaire tachycardie), Opmerking: Een QTcF-interval > 450 milliseconden wordt beschouwd als een klinisch significante ECG-afwijking; d) kunsthartklep; e) aanvullende risicofactoren voor Torsade de pointes (bijv. g., hartfalen, hypokaliëmie, familiegeschiedenis van het lange QT-syndroom); f) enige andere significante huidige of historische cardiovasculaire aandoening, gebaseerd op het klinische oordeel van de studiearts, die een deelnemer ongeschikt voor deelname aan het onderzoek zou maken.","language":18,"languageDescription":"Dutch"}]}]},"endPoint":{"primaryEndPoints":[{"id":1053065,"number":1,"endPoint":"Number, percentage and reasons of screen failures and drop-out","isPrimary":true,"endPointTranslations":[{"id":11115350,"uuid":"8c9a72bc-1e40-4b40-a4cb-c625709fd7e1","attributeTranslation":"Aantal, percentage en redenen van screen failures en drop-out","language":18,"languageDescription":"Dutch"}]},{"id":1053066,"number":2,"endPoint":"Descriptive statistics of the scores on the Treatment Acceptability/Adherence Scale (TAAS-M), measured post-treatment (Visit 16)","isPrimary":true,"endPointTranslations":[{"id":11115351,"uuid":"1e37334a-4642-444b-8af4-f792cf156fa4","attributeTranslation":"Beschrijvende statistieken van de scores op de Treatment Acceptability/Adherence Scale (TAAS-M), gemeten na de behandeling (bezoek 16).","language":18,"languageDescription":"Dutch"}]},{"id":1053067,"number":3,"endPoint":"Qualitative analysis of semi-structured interviews conducted with participants post-treatment (Visit 16)","isPrimary":true,"endPointTranslations":[{"id":11115352,"uuid":"ff2f176e-1363-4087-8a53-6602c29ab8cf","attributeTranslation":"Kwalitatieve analyse van semigestructureerde interviews met deelnemers na de behandeling (bezoek 16)","language":18,"languageDescription":"Dutch"}]},{"id":1053068,"number":4,"endPoint":"Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15).","isPrimary":true,"endPointTranslations":[{"id":11115353,"uuid":"152b6828-7064-4c9a-816f-9eec474e165e","attributeTranslation":"Gemiddelde verandering in de CAPS-5-R Total Severity Score vanaf de baseline meting (bezoek 4) tot 13 weken na de baseline meting (bezoek 15).","language":18,"languageDescription":"Dutch"}]},{"id":1053069,"number":5,"endPoint":"Severity, incidence and frequency of adverse events (AEs),  serious adverse events (SAEs), suicidal ideation and behavior, concomitant medication use, and vital signs throughout the study","isPrimary":true,"endPointTranslations":[{"id":11115354,"uuid":"0e78d227-a7a2-486a-967a-83d69edbcec2","attributeTranslation":"Ernst, incidentie en frequentie van ongewenste voorvallen (AEs), ernstige ongewenste voorvallen (SAEs), suïcidale gedachten en gedrag, gelijktijdig medicijngebruik en vitale functies gedurende het onderzoek.","language":18,"languageDescription":"Dutch"}]},{"id":1053070,"number":6,"endPoint":"Descriptive statistics of changes in Columbia Suicide Severity Rating Scale (C-SSRS) scores","isPrimary":true,"endPointTranslations":[{"id":11115355,"uuid":"446b1f97-1b03-4d1d-9a4f-bcaa82d24b43","attributeTranslation":"Beschrijvende statistieken van veranderingen in de Columbia Suicide Severity Rating Scale (C-SSRS)-scores","language":18,"languageDescription":"Dutch"}]},{"id":1053071,"number":7,"endPoint":"Descriptive statistics of concomitant medication use","isPrimary":true,"endPointTranslations":[{"id":11115356,"uuid":"648db1d6-acbb-4ef1-a0cf-8fe2ec42be95","attributeTranslation":"Beschrijvende statistieken van het gebruik van co-medicatie.","language":18,"languageDescription":"Dutch"}]},{"id":1053072,"number":8,"endPoint":"Mean changes in blood pressure, heart rate, and body temperature from pre-psilocybin administration to end of each Psilocybin Session","isPrimary":true,"endPointTranslations":[{"id":11115357,"uuid":"d63fa878-6aa2-4b83-a15f-0ccde9034a09","attributeTranslation":"Gemiddelde veranderingen in bloeddruk, hartslag en lichaamstemperatuur van vóór de toediening van psilocybine tot het einde van elke psilocybinesessie.","language":18,"languageDescription":"Dutch"}]}],"secondaryEndPoints":[{"id":1053073,"number":1,"endPoint":"Mean change in Sheehan Disability Scale Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15).","isPrimary":false,"endPointTranslations":[{"id":11115358,"uuid":"36b71e45-b0b8-415f-8330-7328363c0548","attributeTranslation":"Gemiddelde verandering in de Sheehan Disability Scale totale ernstscore vanaf de baseline meting (bezoek 4) tot 13 weken na de baseline meting (bezoek 15).","language":18,"languageDescription":"Dutch"}]},{"id":1053074,"number":2,"endPoint":"Mean change in Beck's Depression Inventory-II Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15)","isPrimary":false,"endPointTranslations":[{"id":11115359,"uuid":"a89fbf79-f5c6-4ff3-a6cd-0d7cbcdbd4b5","attributeTranslation":"Gemiddelde verandering in Beck's Depression Inventory-II Total Severity Score vanaf de baseline meting (Bezoek 4) tot 13 weken na de baseline meting (Bezoek 15)","language":18,"languageDescription":"Dutch"}]}]},"trialDuration":{"estimatedEndDate":"2027-12-31","estimatedRecruitmentStartDate":"2026-09-01"},"sourceOfMonetarySupport":[{"id":97406,"organisationName":"Landelijk Zorgsysteem voor Veteranen (LZV)"},{"id":97405,"organisationName":"Filament 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