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 BEHAVIOURAL 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 (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 for reforming 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.
Our Co-operative Study
The planned study has been initiated and is 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 and the MIND Foundation. It is a two-centre 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.
This phase 2b study requires a budget of 3,8 Million Euros to create the safety and data quality needed for approval with the European Medicines Agency and the German Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). The Bundesministerium für Bildung und Forschung (BMBF) has already granted 2,2 million Euros to this study. The approval status of the study will be announced by autumn 2020.
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 a group at the second study centre at Charité Universitätsmedizin Berlin have come together to study the effects of psilocybin-assisted treatment of treatment-resistant depression. This will be the first clinical study of its kind in Germany since the 1970s, with 144 patients planned to be treated. It still needs approval from the BfArM.
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.
Project Updates and Application Progress
The planned study is allocated and managed at the Central Institute of Mental Health Mannheim (University of Heidelberg). Prof. Dr. med. Gerhard Gründer is the Principal Investigator. The second planned study centre is planned to be established at the Charitéb Universitätsmedizin Berlin. The project team intends to set up a project website in the next months. If you want to stay updated about the study application process, please subscribe to the MIND newsletters.