Psilocybin Therapy — Pioneering Work in Germany
Prof. Dr. med. Gerhard Gründer has obtained a special authorisation — on behalf of the Central Institute of Mental Health in Mannheim and OVID Clinic Berlin — to treat a limited number of patients with treatment-resistant depression using psilocybin.
The therapy takes place within the framework of a compassionate use programme. This means that psilocybin may be administered, under specific conditions, to patients for whom guideline-based treatments have proven insufficiently effective — and this is possible prior to the official approval of psilocybin as a licensed medication.
The treatment is conducted in accordance with a protocol officially approved by the Federal Institute for Drugs and Medical Devices (BfArM), which nonetheless allows greater flexibility to accommodate individual patient needs than the stricter protocols of a clinical drug trial.
At OVID Clinic Berlin, Dr. Jungaberle holds the relevant licence in delegation from Prof. Gründer.
Psilocybin Therapy is a Novel Therapeutic Approach with a Growing Evidence Base
Psilocybin is being researched worldwide as a potential treatment for mental health conditions — with promising results in Phase II trials and one initial Phase III study. The therapeutic evidence is particularly growing in the area of treatment-resistant depression. In the United States, an initial approval of psilocybin as a licensed medication is anticipated within the next five years. The FDA has granted Breakthrough Therapy status to three companies — Usona Institute, Compass Pathways and Cybin — for psilocybin as a treatment for both treatment-resistant depression (TRD) and major depressive disorder (MDD) in the case of Usona. Our partner for the current compassionate use programme is the Canadian company Filament Health.
In addition to Germany, special exemption programmes already exist in countries such as Switzerland, Australia and Canada, enabling patients to receive psilocybin treatment under specific conditions.
The Therapeutic Potential of Psychedelics
Psychedelics are substances that can temporarily and profoundly alter consciousness, perception and thought. Classical psychedelics include psilocybin, lysergic acid diethylamide (LSD) and dimethyltryptamine (DMT). Since the 2000s, psychedelic research has experienced a renaissance. Numerous clinical studies have since been conducted on the treatment of various psychiatric conditions — including depression, generalised anxiety disorder (GAD) and post-traumatic stress disorder (PTSD). The results to date regarding the safety and efficacy of these substances are promising. Psychedelic therapy is always administered in combination with psychotherapy — meaning that substance sessions take place in the presence of trained therapists and are embedded within psychotherapeutic sessions for preparation and integration. The precise structure of the therapy always depends on the respective study and is defined in the study protocol.
Important: Psychedelics are used exclusively within the framework of controlled clinical trials or compassionate use programmes. 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 universal remedy. When used inappropriately, they can trigger acute anxiety states, psychotic episodes and, in isolated cases, long-term effects such as persistent perceptual disturbances (HPPD). Individuals with pre-existing psychiatric conditions — particularly a predisposition to psychosis — should refrain from use under any circumstances. At OVID Clinic Berlin, we conduct a thorough pre-treatment assessment to determine whether therapy is suitable for you.
Psilocybin for Treatment-Resistant Depression
Clinical research is most advanced in the area of depressive disorders, including so-called treatment-resistant depression. One of the most recent and largest studies — involving 144 patients — on the treatment of treatment-resistant unipolar depression with psilocybin was conducted from June 2021 to December 2024, led by the Central Institute of Mental Health in collaboration with Charité – Universitätsmedizin Berlin and the MIND Foundation. This was the EPIsoDe study. The results demonstrate good efficacy and safety of a high dose (25 mg) of psilocybin with accompanying psychotherapy. At the end of the study after twelve weeks — following participants receiving either one or two high doses of psilocybin six weeks apart — approximately 30 percent showed a treatment response. This means that their score on a standard depression scale had decreased by at least 50 percent.
Provided the results of currently ongoing Phase 3 trials are positive, approval of psilocybin for depression in Germany is anticipated within the next five years — and likely sooner in the United States.
Treatment Options in Germany and at OVID Clinic Berlin
Treatment with a classical psychedelic such as psilocybin is currently only permitted in Germany within the framework of officially approved clinical trials, pharmaceutical companies, or clinics holding a special authorisation from the BfArM. These substances are subject to the Narcotics Act (BtMG) and are illegal outside of medical and scientific contexts.
Other Current Studies Involving a Classical Psychedelic at OVID Clinic Berlin
- Lysergic acid diethylamide (LSD)-D-tartrate (MM120) for the treatment of generalised anxiety disorder.
What is a Compassionate Use Programme?
Since 11 July 2025, treatment with psilocybin for treatment-resistant depression has been possible on an exceptional basis within the compassionate use programme at OVID Day Clinic in Berlin and at the Central Institute of Mental Health in Mannheim, under the leadership of Prof. Dr. Gerhard Gründer.
A compassionate use programme enables the use of as yet unlicensed medications in patients who:
- suffer from serious or life-threatening conditions,
- for whom no satisfactory treatment with licensed medications exists, and
- for whom participation in a clinical trial with the medication is not possible.
Important: These programmes are time-limited and conducted under strictly regulated conditions.
Treatment with psilocybin within the compassionate use programme at OVID Clinic Berlin takes place exclusively in the day clinic setting — not on an outpatient basis. Within the day clinic treatment, psilocybin (typically 25 mg) is administered in individual doses in combination with accompanying psychotherapy and a therapy programme individualised for each patient. The aim is to dissolve rigid thought patterns, foster new insights, perspectives and behaviours, and improve depressive symptoms.
The treatment team draws on many years of experience in psychotherapy and psychiatry as well as clinical trials with psilocybin and other psychedelic substances. On this basis, specific safety protocols and treatment guidelines have been developed to ensure the best possible care and treatment.
Contact
If you are interested in treatment at OVID Clinic Berlin within the compassionate use programme and believe you meet the eligibility criteria, please get in touch — with your consent to the storage of your data and including your full contact details — at info@ovid-clinic.com.
For enquiries regarding participation in the psilocybin treatment programme at the Central Institute of Mental Health in Mannheim, please contact: Click here.
The expertise of our senior physicians in working with psilocybin is grounded in the experience gained through the EPIsoDe psilocybin study.
Learn more in the Arte documentary Healing Drugs.
