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GERMAN PSILOCYBIN STUDY APPROVED BY BFARM

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.

Collaboration Study

The study received final approval from the Federal Institute of Drugs and Medical Devices (BfArM) on November 17, 2020. The study will start recruiting patients in March 2021 and will begin treating patients shortly after. It will be led by Principal Investigator Prof. Dr. med. Gerhard Gründer at the Central Institute of Mental Health Mannheim who is working together with a group at the Charité Universitätsmedizin Berlin, the MIND Foundation and OVID Health Systems. 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. We expect 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, we 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). His research group in Mannheim, a team at the MIND Foundation and our clinical partner organization OVID, as well as a group at the second study center at Charité Universitätsmedizin Berlin have come together to study the effects of psilocybin-assisted treatment of treatment-resistant depression. This is the first clinical study of its kind in Germany since the 1970s, with 144 patients planned to be treated. The British-based company Compass Pathways conducts a study with over 200 patients worldwide. In the context of this research another Compass Pathway sponsored study with Psilocybin in treatment-resistant depression plans to treat approximately 15 patients at the Campus Benjamin Franklin Charité Universitätsmedizin.

This study is embedded into 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. Its aim is to develop tailored treatments for those with mental illnesses as quickly as possible based on the scientific principles researched at CIPP.

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]

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