{"id":5109,"date":"2025-08-13T11:23:24","date_gmt":"2025-08-13T09:23:24","guid":{"rendered":"https:\/\/avextra.com\/?p=5109"},"modified":"2025-08-13T11:24:00","modified_gmt":"2025-08-13T09:24:00","slug":"first-patient-included-marks-major-milestone-in-eu-funded-clinical-trial","status":"publish","type":"post","link":"https:\/\/avextra.com\/it\/2025\/08\/first-patient-included-marks-major-milestone-in-eu-funded-clinical-trial\/","title":{"rendered":"First Patient Included Marks Major Milestone in EU-Funded Clinical Trial"},"content":{"rendered":"<p><strong><strong><strong>Bensheim, Germany, August 11, 2025<\/strong><\/strong> \u2013<\/strong>\u00a0PsyPal has reached a major milestone with the inclusion of its first patient in the multi-site clinical trial investigating psilocybin therapy for psychological and existential distress in people with progressive, life-limiting illnesses. The first patient has been included at University Medical Center Groningen (UMCG), Netherlands, one of four specialised clinical centres participating in this unprecedented, EU-funded initiative.<\/p>\n\n\n\n<p>\u201cThis is a historic step,\u201d says Prof. Dr. Robert Schoevers, head of psychiatry at the University Medical Center Groningen (UMCG) and principal investigator of PsyPal. \u201cAfter many months of preparation, we are thrilled to begin working directly with patients.\u201d<\/p>\n\n\n\n<p>Funded by the European Union and coordinated by UMCG in the Netherlands, PsyPal is the first European Union-funded multi-site clinical trial on psilocybin therapy. Specifically, the trial will explore whether psilocybin, administered in a supportive psychotherapeutic context, can help reduce depression, anxiety, and improve quality of life in individuals living with chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or advanced and atypical parkinsonian disorders (APD). \u201cToo many people in need of palliative care endure overwhelming psychological and existential distress that conventional treatments often fail to address,\u201d says Stephan Tap (UMCG), clinical trial manager. Ulf Bremberg (Osmond Labs), project manager, adds:\u00a0 \u201cBy combining psychotherapy with a novel compound like psilocybin, we hope to offer support that extends beyond symptom relief, into the deeply human realms of connection, meaning, and peace.\u201d<\/p>\n\n\n\n<p><strong>Each clinical site focuses on one of the four targeted conditions:<\/strong><\/p>\n\n\n\n<ul>\n<li><strong>COPD<\/strong> \u2013 University Medical Center Groningen (UMCG), Netherlands<\/li>\n\n\n\n<li><strong>APD<\/strong> \u2013 Champalimaud Foundation, Portugal<\/li>\n\n\n\n<li><strong>MS<\/strong> \u2013 National Institute of Mental Health, Czech Republic<\/li>\n\n\n\n<li><strong>ALS<\/strong> \u2013 University of Copenhagen and Bispebjerg Hospital, Denmark<\/li>\n<\/ul>\n\n\n\n<p>The trial will eventually involve over 100 patients across Europe, each undergoing two therapy sessions with either a therapeutic dose (high-dose) of psilocybin or a non-therapeutic dose (low-dose) in a controlled clinical setting. This is the first time a psychedelic substance is being studied in a clinical trial targeting patients who have palliative care needs, other than for cancer, in Europe. Therefore, the first patient included in the PsyPal study marks the beginning of a new chapter in European mental healthcare research.<\/p>\n\n\n\n<p>The study medication (psilocybin) and the entire supply chain process are fully supported by Avextra Pharma, a German research-oriented biotech company dedicated to researching and developing plant-based medicines. In collaboration with Avextra, the PsyPal consortium is dedicated to advancing the clinical understanding, accessibility, and evidence of psilocybin therapy for patients with significant needs across Europe.<\/p>\n\n\n\n<p><strong>Stay informed<\/strong> \u2013 Sign up to the <a href=\"https:\/\/palliativeprojects.eu\/psypal\/newsletter\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-primary-color\"><em>PsyPal newsletter<\/em><\/mark><\/strong><\/a> to stay informed about patient recruitment, study progress, and more. <\/p>\n\n\n\n<div class=\"wp-block-group is-nowrap is-layout-flex wp-container-core-group-layout-1 wp-block-group-is-layout-flex\">\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"99\" height=\"95\" src=\"https:\/\/avextra.com\/wp-content\/uploads\/2025\/08\/EU-Logo.png\" alt=\"\" class=\"wp-image-5111\" style=\"width:167px;height:auto\" srcset=\"https:\/\/avextra.com\/wp-content\/uploads\/2025\/08\/EU-Logo.png 99w, https:\/\/avextra.com\/wp-content\/uploads\/2025\/08\/EU-Logo-13x12.png 13w\" sizes=\"(max-width: 99px) 100vw, 99px\" \/><\/figure>\n\n\n\n<p><strong>Disclaimer<\/strong> \u2013 PsyPal is funded by the European Union. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.<\/p>\n<\/div>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-primary-color has-text-color has-link-color wp-elements-22d3562b5d8534e0211e0aa374d0e4a2\"><strong><em><a href=\"https:\/\/palliativeprojects.eu\/psypal\/2025\/08\/11\/first-patient-included-marks-major-milestone-in-eu-funded-clinical-trial\/\" target=\"_blank\" rel=\"noreferrer noopener\">Maggiori informazioni:<\/a><\/em><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Bensheim, Germany, August 11, 2025 \u2013\u00a0PsyPal has reached a major milestone with the inclusion of its first patient in the multi-site clinical trial investigating psilocybin therapy for psychological and existential distress in people with progressive, life-limiting illnesses. The first patient has been included at University Medical Center Groningen (UMCG), Netherlands, one of four specialised clinical centres participating in this unprecedented, EU-funded initiative.<\/p>","protected":false},"author":1,"featured_media":5110,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"einzelbeitrag-ohne-bild","format":"standard","meta":{"inline_featured_image":false,"advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[8,9],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>First Patient Included Marks Major Milestone in EU-Funded Clinical Trial - Cannabisbasierte Arzneimittel von Avextra<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/avextra.com\/it\/2025\/08\/first-patient-included-marks-major-milestone-in-eu-funded-clinical-trial\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First Patient Included Marks Major Milestone in EU-Funded Clinical Trial - Cannabisbasierte Arzneimittel von Avextra\" \/>\n<meta property=\"og:description\" content=\"Bensheim, Germany, August 11, 2025 \u2013\u00a0PsyPal has reached a major milestone with the inclusion of its first patient in the multi-site clinical trial investigating psilocybin therapy for psychological and existential distress in people with progressive, life-limiting illnesses. 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