Germany’s Federal Ministry of Education and Research (BMBF) has provided a grant of €2.6m for a study exploring the efficacy of psilocybin as a treatment for resistant depression.
The “Efficacy and safety of Psilocybin In treatment-reSistant majOr DEpression” (EpisoDE) study launched in 2021 and is being carried out by the Central Institute for Mental Health (CIMH) Mannheim.
Partner and second study centre is the Clinic for Psychiatry and Psychotherapy at the Charité Berlin Campus Mitte, and the Federal Ministry of Education and Research (BMBF) and the MIND Foundation are both sponsoring the project.
According to the CIMH, the funding, which will see around €2.3 million going to Mannheim and €300,000 going to Berlin, will enable the investigation of biomarkers that could inform who may benefit from psychedelic treatment and to what extent, enabling the research to begin a Phase 3 study, integrating the learnings from the EPIsoDE study.
Speaking to Psychedelic Health, Professor Dr Gerhard Gründer, Professor of Psychiatry and Head of the Molecular Neuroimaging Department at the Central Institute of Mental Health (CIMH), commented: “The additional funding now approved means that the EPIsoDE study is now being funded with a total of almost €5 million.
“This takes account of the fact that psychedelic-assisted psychotherapy is one of the most important – and perhaps the most important – current developments in psychiatry.
“The German government has recognised that people’s mental health is one of the most important challenges of our time and that Germany must take a leading role in the development of these therapies in Europe.”
The study
For the study, researchers are administering a high therapeutic dose, a low dose and a control substance.
They will be investigating whether psilocybin has better antidepressant efficacy than a placebo and which dose produces the best antidepressant effect, as well as whether multiple doses of psilocybin produce a better antidepressant effect than a single dose.
Following three preparation sessions, the psilocybin treatment takes place in two eight-hour sessions six weeks apart where patients are given either 5 or 25 mg psilocybin or a placebo.
The CIMH states that this is then followed by two integration sessions – one day and one week after each substance session – to integrate the therapeutic support.
It also highlights that each patient receives at least one presumably therapeutic dose of psilocybin: “Part of the study group will receive psilocybin in two sessions, while the rest of the group will receive one placebo and one psilocybin.”
Studies will also be carried out on the cost-effectiveness of psychedelic-assisted psychotherapy.
Psychedelic research in Germany
Whilst Germany has been gaining increasing media attention over its plans to make progressive changes to its cannabis policy through the introduction of a regulated, adult-use market, the German government’s decision to fund this psilocybin study demonstrates its openness to medical psychedelics.
Currently, Germany offers ketamine-assisted therapy for patients with mental health conditions such as depression, anxiety and post-traumatic stress disorder (PTSD), and is home to psychedelics company atai Life Sciences.
The country has been no stranger to psychedelic research over the years, with German pharma company Merck being the first to synthesise MDMA in 1912 – the effects of which were later discovered by Alexander Shulgin.
Adding to this, whilst research on LSD was carried out in Germany throughout the 50s and 60s, it continued throughout the 70s when psychedelic research was stopped elsewhere, only coming to end in 1992.
Dr Henrik Jungaberle, Director of the MIND Foundation, told Psychedelic Health: “The German government was the first leading Western nation that provided a grant for a large clinical study with psychedelics.
“Now the government has confirmed its commitment to the new field by doubling the budget for this methodically advanced study. This is a relief and support for the research team and medicine as a whole. It helps to counter stigmatisation and supports implementation of psychedelic therapies.
“The increased EPIsoDE budget enables us to realise the side studies on neuroimaging, genetics, and several additional biological aspects of psilocybin-augmented therapy. This will add to our common knowledge on screening parameters and safety in later implementation.
“The current grant is a confirmation for the study team to proceed to a Phase 3 psilocybin study in which we want to integrate the learnings from EPIsoDE. Internally, it takes away some of the enormous pressure to work over hours that the team is facing.”
