Psilocybin therapy in Berlin: compassionate use for treatment-resistant depression with psychotherapy and BfArM-approved protocols

Psilocybin therapy in Berlin is presented for treatment-resistant depression through a German compassionate use program rather than routine approval. The clinic states that Prof. Dr. med. Gerhard Gründer received special permission for a limited number of patients, with Dr. med. Andrea Jungaberle holding the delegated license. The page says psilocybin is administered under a protocol approved by Germanys Federal Institute for Drugs and Medical Devices (BfArM), aiming to give more room for individual patient needs than stricter drug trial protocols. It also emphasizes that treatment combines psilocybin administration with psychotherapy, typically in an individualized day clinic setting, and frames this as part of preparation, dosing, and follow-up care. The clinic cites supporting evidence including the EPIsoDE study (144 patients) using a high dose of 25 mg with accompanying psychotherapy, and it describes eligibility screening, risks, and contraindications such as elevated risk in people with psychosis tendencies. It also notes legal restrictions under the Narcotics Act (BtMG), stating psilocybin use is limited to controlled clinical trials or special approvals.