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GERMAN PSILOCYBIN STUDY AT THE CENTRAL INSTITUTE OF MENTAL HEALTH AND CHARITÉ UNIVERSITÄTSMEDIZIN APPROVED BY BFARM

MIND is a cooperation partner

The information on this website is regularly updated to match the developments on approval, financing, and legal issues, particularly legal agreements after approval. A study website will soon be published by the Central Institute of Mental Health (CIMH) and the information on this website will then be moved there to make it easier for patients to apply and mental health professionals to refer their patients to the two study centers. We will then switch to reporting important updates in our newsletters and blogposts. Until then, please use the emails at the bottom of the page to connect to the study centers.
Caution: Since there have been some misunderstandings in press outlets, please don’t report about this study as “the MIND study”. It is a study applied for, approved, and run at the Central Institute of Mental Health Mannheim led by Prof. Dr. Gerhard Gründer. A second study center has been established at the Charité Universitätsmedizin Berlin. MIND is a cooperation partner in this study (see below what we do), we are not the “sponsor” or “owner”.
Press requests: [email protected]

A Mental Health Crisis

The World Health Organization estimates that more than 322 million people worldwide suffer from depression. Approximately 50% of those with depression suffer from treatment-resistant depression, or TRD, signifying that current treatments are often ineffective. Given the scarcity of innovative pharmacological approaches in psychiatry, interest in psychedelic drugs (e.g. psilocybin, the active ingredient in “magic mushrooms”) has regrown.

IN GERMANY ALONE, THE TOTAL COSTS FOR MENTAL AND BEHAVIORAL DISORDERS ARE ESTIMATED TO BE 30.324 MILLION € (WWW.GBE-BUND.DE). THIS HIGH DISEASE BURDEN, OFTEN EXACERBATED BY CHRONIC DISEASES LIKE TRD, HIGHLIGHTS THE IMPORTANCE OF INVESTIGATING PROMISING NOVEL TREATMENTS.

The treatment model of psilocybin therapy (supposedly requiring only one or very few drug administrations) is inherently different from classical psychiatric medications, which usually require sustained intake. Psilocybin could certainly enrich, if not become a building block in the reformation of psychiatric care. The proposed treatment might be more effective for certain patients and does not require long-term medication, potentially making the treatment more cost-effective.

The EPIsoDE Psilocybin Depression Study

The study is hosted, conducted and was applied for from and at the Central Institute of Mental Health Mannheim (CIMH). The CIMH and the Charité Universitätsmedizin received final approval from the Federal Institute of Drugs and Medical Devices (BfArM) on November 17, 2020. The team will start recruiting patients in March 2021 and will begin treating patients shortly after. It is led by Principal Investigator Prof. Dr. med. Gerhard Gründer at the Central Institute of Mental Health Mannheim. The study is supported by the MIND Foundation. It is a two-center study that aims to investigate the safety and efficacy of psilocybin administered under supportive conditions in a controlled, randomized, double-blind design. Only such a study can pave the way for future phase III studies and regulatory approval of this drug for standard treatment. The study team expects significant treatment responses with a therapeutic (25 mg) oral dose of psilocybin in comparison to an active control dose of psilocybin (5 mg) and niacin, a second placebo we will use. In order to optimize psilocybin treatment regimes in clinical practice, the study will investigate the effect of administering a second therapeutic dose six weeks after the first therapeutic dose.

The Team

Principal Investigator Prof. Dr. med. Gerhard Gründer is head of the Department of Molecular Neuroimaging of the Central Institute of Mental Health Mannheim (University of Heidelberg). This is the first clinical study of its kind in Germany since the 1970s, with 144 patients planned to be treated. Additionally, the British-based company Compass Pathways conducts a study with over 200 patients worldwide. As part of this study, a group at the Campus Benjamin Franklin Charité Universitätsmedizin plans to treat about 15 patients with psilocybin in treatment-resistant depression.

The EPIsoDE study is embedded in the Center for Innovative Psychiatric and Psychotherapeutic Research (CIPP), which was designed to enable psychiatric and psychotherapeutic treatment research to be carried out at a new level of quality. It aims to develop tailored treatments for those with mental illnesses as quickly as possible based on the scientific principles researched at CIPP.

The MIND Foundation team is a cooperation partner. We do not receive any funds from the study. On the contrary, we supports the study logistically by organizing the training of therapists and finance two doctoral students and a senior researcher at MIND.

How Can Patients Participate?

Patient recruitment will begin in March 2021. If you have a patient or someone else that you know is interested in participating in this study as a patient and is diagnosed with treatment-resistant depression, please contact the appropriate study center below. The study will be conducted and managed at the Central Institute of Mental Health Mannheim (University of Heidelberg), with the second study center at the Charité Universitätsmedizin Berlin.

Contact the Central Institute of Mental Health Mannheim:

[email protected]

Contact the Charité Universitätsmedizin Berlin:

[email protected]

Project Updates

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