The Central Institute of Mental Health (CIMH) in Mannheim has received approval for the use of psilocybin in treatment-resistant depression as part of a Compassionate Use Program in Germany. Under the direction of Prof. Dr. Gerhard Gründer, individual patients in Mannheim and Berlin will be able to receive the drug in justified exceptional cases. The Compassionate Use Program is not a substitute for the approval of psilocybin. The CIMH assumes that the demand for treatment will significantly exceed capacity.
Psilocybin promising in treatment
Depression is one of the most common mental illnesses in Germany. Although there are many established treatment methods, around 20 to 30 percent of those affected do not respond adequately to treatment and are therefore considered treatment-resistant. In recent years, numerous scientific studies have shown psilocybin to be a promising treatment for therapy-resistant depression. Psilocybin is a psychedelic whose active ingredient is found in certain types of mushrooms, such as magic mushrooms. However, approval in Germany is not expected for several years at the earliest. Until then, no approved treatment options with psilocybin are available.
However, physicians have the option of treating seriously ill patients with drugs that have not yet been approved via an Expanded Access Program (EAP), a so-called compassionate use procedure. This is not a regular therapeutic offer, but an exceptional authorization that is granted in individual cases. So far, such Compassionate Use Programs for psilocybin have only been established in very few countries worldwide, for example in Switzerland and Canada.
First Compassionate Use Program in the European Union
The CIMH in Mannheim, working together with Filament Health, has now succeeded in obtaining approval for the use of psilocybin in treatment-resistant depression as part of such an Expanded Access Program in Germany. This is the first Compassionate Use Program for this active substance in the European Union. In the future, individual adult patients with treatment-resistant depression can be treated with psilocybin at the CIMH in Mannheim and at the day clinic of the OVID Clinic Berlin as part of a Compassionate Use Program – but only in justified exceptional cases.
“This is an enormously important step that expands our scope for action. In selected individual cases, the therapeutic use of psilocybin as part of a Compassionate Use Program can be a medically and ethically justifiable option, provided it is carried out under strictly controlled conditions and with careful medical supervision,” says Prof. Dr. Gerhard Gründer, Head of the Department of Molecular Neuroimaging at the CIMH, who successfully submitted the application to the Federal Institute for Drugs and Medical Devices (BfArM) in Germany.
Risk-benefit assessment for each case
An Expanded Access Program enables the use of as yet unapproved drugs in patients suffering from serious or life-threatening illnesses. Further conditions must be met, for example, there must be no satisfactory treatment with approved drugs and participation in a clinical trial with the drug must not be possible. Each case must be carefully examined in terms of a risk-benefit assessment. “Responsible medical and therapeutic support is important. Both locations, the Central Institute of Mental Health in Mannheim and the OVID Day Clinic in Berlin, rely on their many years of experience from several research studies with psychedelics,” says Prof. Gründer.
A Compassionate Use Program is limited in time, and treatment takes place under strictly regulated conditions. “Experience from Switzerland shows that demand far exceeds the available supply. This is also likely to be the case in Germany,” explains Prof. Gründer. “A Compassionate Use Program cannot replace approval. We must therefore continue to work on bringing psychedelics such as psilocybin into standard care for the treatment of mental illness,” says Gründer.
Therapeutic preparation and follow-up
Treatment with psilocybin as part of the Expanded Access Program in Mannheim and Berlin takes place exclusively on an inpatient basis. Patients must also attend outpatient appointments, firstly to clarify the eligibility requirements and secondly for therapeutic preparation and follow-up. In therapy, psilocybin is used in single doses in combination with accompanying psychotherapy. The aim of the treatment in Mannheim and Berlin is to release rigid thought patterns, promote new insights, perspectives and behaviors and improve depressive symptoms. The pharmaceutical PEX010, a botanical psilocybin drug candidate, is provided by Filament Health, a Canadian company that develops natural psychedelic drugs and extracts psilocybin from mushrooms. Filament has been a leading force in Canada’s Special Access Program, supplying the vast majority of psilocybin prescribed through the country’s compassionate access pathway.