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Psilocybin therapy – pioneering work in Germany
Prof. Dr. med. Gerhard Gründer has received special permission for the Central Institute for Mental Health in Mannheim and the OVID Clinic Berlin to treat a limited number of patients with treatment-resistant depression using psilocybin.
The therapy is provided as part of a compassionate use program. This means that the drug psilocybin may be used under certain conditions in patients for whom standard therapies have not been sufficiently effective – even before psilocybin has been officially approved as a drug.
The drug is administered in accordance with a protocol approved by the Federal Institute for Drugs and Medical Devices (BfArM), which allows more leeway for the individual needs of patients than the stricter protocols of a drug trial.
At the OVID Clinic Berlin, Dr. med. Andrea Jungaberle holds the appropriate license delegated by Prof. Dr. med. Gerd Gründer.
Psilocybin therapy is a new therapeutic approach with a growing scientific basis
Psilocybin is being researched worldwide as a potential drug for the treatment of mental illness, with promising results in Phase II and an initial Phase III study. There is growing therapeutic evidence, especially in the area of treatment-resistant depression. In the US, psilocybin is expected to be approved as a drug within the next five years. The U.S. FDA has granted three companies – Usona Institute, Compass Pathways and Cybin – breakthrough status for psilocybin as a treatment for both treatment-resistant depression (TRD) and, in the case of Usona, major depressive disorder (MDD). Our partner for the current compassionate use program is the Canadian company Filament Health.
In addition to Germany, special exemption programs already exist in countries such as Switzerland, Australia, and Canada, which allow patients to receive treatment with psilocybin under certain conditions.
Therapeutic potential of psychedelics
Psychedelics are substances that can temporarily and profoundly alter consciousness, perception, and thinking. Classic psychedelics include psilocybin, lysergic acid diethylamide (LSD), and dimethyltryptamine (DMT). Since the 2000s, research into psychedelics has been experiencing a renaissance. Numerous clinical studies have since been conducted on the treatment of various psychiatric disorders, such as depression, generalized anxiety disorder (GAD), and post-traumatic stress disorder (PTSD). The results to date on the safety and efficacy of these substances are promising. Treatment with psychedelics is always combined with psychotherapy, meaning that the substances are administered under the supervision of therapists and are embedded in psychotherapeutic sessions for preparation and follow-up. The exact course of therapy always depends on the respective study and is specified in the study's protocol.
Important: Psychedelics are used exclusively in controlled clinical trials or in a compassionate use program. Non-medical use carries significant risks to mental health and social stability.
Risks and contraindications
Despite their potential benefits, psychedelics—like all medications—are not a panacea. If used improperly, they can trigger acute anxiety, psychotic episodes, and, in isolated cases, long-term effects such as hallucinogen persisting perception disorder (HPPD). People with a history of psychiatric disorders—especially a tendency toward psychosis—should refrain from taking psychedelics. At the OVID Clinic Berlin, we determine in advance whether you are eligible to participate in this therapy.
Psilocybin for treatment-resistant depression
The most advanced clinical research on psilocybin is in the treatment of depressive disorders, including so-called treatment-resistant depression. One of the most recent and largest studies observing psilocybin for treatment-resistant unipolar depression, involving 144 patients, was conducted from June 2021 to December 2024 under the leadership of the Central Institute of Mental Health in cooperation with Charité – Universitätsmedizin Berlin and the MIND Foundation – the EPIsoDE study. The results show sound efficacy and safety of a high dose (25 mg) of psilocybin with accompanying psychotherapy. At the end of the study twelve weeks later – after participants had received either one or two high doses of psilocybin six weeks apart – about 30 percent showed a response to treatment. This means that the score on a standard depression scale decreased by at least 50 percent.
Provided that the results of ongoing Phase 3 studies are positive, psilocybin is expected to be approved for the treatment of depression in Germany within the next five years, and probably sooner in the US.
Treatment options in Germany and at the OVID Clinic Berlin
Treatment with a classic psychedelic drug such as psilocybin is currently only permitted in Germany within the framework of officially approved clinical trials, pharmaceutical companies, or clinics with special approval from the BfArM. The substances are subject to the Narcotics Act (BtMG) and are illegal outside of medical and scientific contexts.
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Lysergic acid diethylamide (LSD)-D-tartrate (MM120) for the treatment of generalized anxiety disorder
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Status: Recruitment of study participants will begin in August 2025 (info@ovid-clinics.com)
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What is a compassionate use program?
As of July 11, 2025, treating treatment-resistant depression with psilocybin therapy is possible in exceptional cases under the German Compassionate Use Program at the OVID Day Clinic in Berlin and at the Central Institute for Mental Health in Mannheim. It is under the direction of Prof. Dr. med. Gerhard Gründer.
A Compassionate Use Program allows the use of drugs that have not yet been approved for patients who
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suffer from severe or life-threatening illnesses
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for whom there is no satisfactory treatment with approved drugs, and
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for whom participation in a clinical trial with the drug is not possible.
Important: These programs are limited in time and are carried out under strictly regulated conditions.
Treatment with psilocybin as part of the compassionate use program at the OVID Clinic Berlin takes place exclusively in the day clinic, i.e., not on an outpatient basis. As part of the day clinic treatment, one dose of psilocybin (usually 25 mg) is used in combination with accompanying psychotherapy within an individualized therapy program. The aim is to break rigid thought patterns, promote new insights, perspectives, and behaviors, and improve depressive symptoms.
The treatment team draws on many years of experience in psychotherapy and psychiatry, as well as clinical studies with psilocybin and other psychedelic substances. Based on this, specific safety protocols and treatment guidelines have been developed to ensure the best possible care and treatment.
Contact
Sollten Sie Interesse an einer Behandlung in der OVID Clinic Berlin im Rahmen des Compassionate-Use-Programms haben und glauben, die Eignungsvoraussetzungen zu erfüllen, melden Sie sich bitte mit Zustimmung zur Speicherung Ihrer Daten und unter Angabe Ihrer vollständigen Kontaktinformationen bei info@ovid-clinics.com.
For inquiries about participating in the psilocybin treatment program at the Central Institute for Mental Health in Mannheim, please contact: Click here
The expertise of our chief physicians in the use of psilocybin is based on their previous experience in the EPIsoDe psilocybin study.
Find out more in the Arte documentary Healing Drugs.
Information about psilocybin
Psilocybin is a psychoactive substance that occurs naturally in certain types of mushrooms. For clinical studies, however, the substance containing the active ingredient is produced in a laboratory or extracted from a mushroom. When orally consumed, psilocybin is converted into psilocin, which has the actual pharmacological effect. Psilocybin is currently being investigated in controlled clinical trials for conditions including treatment-resistant depression, anxiety, and addiction.
Impressions of the OVID Day Clinic & Practice
