Research projects

Psilocybin, the active substance in the so-called “magic mushrooms”, is a psychedelic substance. These substances can profoundly alter one’s perception, emotional experience and consciousness. This makes them interesting for the treatment of mental illnesses. Pilot studies have shown that psilocybin can have a rapid and long-lasting effect on depression, anxiety disorders and substance use disorders. Therefore, it is considered a promising approach for patients with depression who have exhausted other treatment options without success. But so far, there is a lack of evidence for the efficacy of psilocybin in so-called treatment-resistant depression. To change this and to explore the potential of psilocybin in more detail, one of the world’s largest studies in this field has been launched in Mannheim and Berlin in 2021. The Central Institute of Mental Health (CIMH) in Mannheim is coordinating the study, which is being conducted together with the partners Charité – Universitätsmedizin Berlin and the MIND Foundation in Berlin.

Almost 2.6 million euros for further research

The additional funding of almost 2.6 million euros now approved by the Federal Ministry of Education and Research in Germany (BMBF) (almost 2.3 million euros will go to Mannheim, about 300,000 euros to Berlin) will allow the investigation of further important scientific questions. For example, biological characteristics of the participants in the blood or in tissue samples, so-called biomarkers, are to be measured. The team led by Prof. Dr. Gerhard Gründer hopes that this will provide further information on who can benefit from psychedelic treatment and to what extent. Additionally, studies on the cost-effectiveness of psychedelic-assisted psychotherapy or on the acceptance of this type of therapy among therapists, payers and the population are now also planned.
“This new federal funding recognises the potential importance of psychedelic-assisted psychotherapy as an innovative and promising form of therapy,” says Prof. Dr. Gerhard Gründer, head of the study and also head of the Department of Molecular Neuroimaging at the CIMH.

Two psilocybin sessions at six-week intervals

The first results are expected in autumn 2023. The study is open to 144 patients with depression between the ages of 25 and 65, for whom other therapies are not or no longer effective. Treatment will take place in two approximately six-hour psilocybin sessions at intervals of six weeks. In addition, there are a total of three preparatory sessions and four integration sessions in which the psilocybin experiences are embedded in the personal life context with therapeutic support. In the psilocybin sessions, participants receive either 5 or 25 mg of psilocybin or a placebo. After six and twelve months, follow-up examinations are carried out in each case to record long-term effects.

About the study

Efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE)

The given bi-centric, randomised, double-blind, placebo-controlled phase II study aims to investigate the efficacy and safety of 25 mg oral psilocybin compared with 5 mg oral psilocybin (presumably non-effective control dose) or 100 mg nicotinamide (active placebo) administered in a supportive setting for treatment-resistant depression.

The study is being funded by the Federal Ministry of Education and Research (BMBF); it is further supported financially and with personnel by the non-profit MIND Foundation. The study was approved by the Federal Institute for Drugs and Medical Devices on 17 November 2020. The study was initiated in June 2021.

Which patients can participate in the study?

People with treatment-resistant moderate to severe depression (HAM-D scale score ≥ 17) aged 25 to 65 years who

- have no family history of psychosis and/or bipolar disorder,

- do not suffer from schizophrenia and other psychotic disorders, borderline personality disorder and/or substance use disorder,

- do not have any serious physical or neurological illnesses that prevent them from taking a psychedelic,

- are neither pregnant nor breastfeeding.

Contact

Those interested are welcome to contact one of the two study centres:
Mannheim: e-mail: probanden.episode@zi-mannheim.de
Berlin: e-mail: episode-studie@charite.de

About CIMH

The Central Institute of Mental Health (CIMH) stands for internationally outstanding research and pioneering treatment concepts in psychiatry and psychotherapy, child and adolescent psychiatry, psychosomatics and addiction medicine. The CIMH clinics provide psychiatric care for the population of Mannheim. At the CIMH, mentally ill people of all ages can rely on the most advanced treatments based on international standards of knowledge. Educating people about mental illness, creating understanding for those affected and strengthening prevention is another important part of our work. In psychiatric research, the CIMH is one of the leading institutions in Europe. Since 2021, it has been a site of the German Centre for Mental Health. The CIMH is institutionally linked to the University of Heidelberg through jointly appointed professors from the Mannheim Medical Faculty.

About Charité

Charité is one of the largest university hospitals in Europe, boasting 3,099 beds and approximately 100 departments and institutes spread across 4 separate campuses. At Charité, the areas of research, teaching and medical care are closely interlinked. With a total of 20,921 members of staff employed across its group of companies (17,615 of which at Charité), the organization is one of the largest employers in Berlin. Charité’s Medical Faculty is one of the largest in Germany, educating and training more than 9,000 students across the subjects of medicine, dentistry, health sciences and nursing. Charité also offers 730 training positions across 11 different health care professions, in addition to 111 training positions in a further 8 professions.

About MIND-Foundation

The MIND Foundation is a European non-profit scientific and educational organisation that promotes psychedelic research and therapy. Its work is based on the neurobiological and psychological potential of psychedelics to improve mental health and well-being in a clinical setting. The MIND Foundation's programmes include advanced clinical training for physicians and psychotherapists (APT), as well as harm reduction and personal development.

---

Weitere Informationen:
https://episode-study.de/ Further information on the study website