Research & trials
Psilocybin therapy is a medical practice in which psilocybin, a psychoactive medicine, is administered to a patient during a session supported by a therapist. A psychoactive medicine is one that affects brain function and results in a change in cognition, perception or behaviour.
The timeline below shows some of the key developments in psilocybin research in the last few decades.
In particular, a number of small academic studies have suggested that psilocybin therapy provides immediate and sustained reductions in depression and other illnesses, following a single treatment. The timeline links to the relevant clinical study reports.
Sandoz chemist Albert Hofmann isolated and determined the structure of psilocybin
Launch of Indocybin (psilocybin)
Discontinued distribution of Indocybin due to misuse
Strassman et al, Journal of Psychopharmacology, First significant psychoactive trial (Di-Methyl-Tryptamine or DMT)
Moreno et al, Clinical Psychiatry, Obsessive Compulsive Disorder
Grob et al, Archives of General Psychiatry, Existential distress
Johnson et al, Journal of Psychopharmacology, Tobacco dependence
Bogenschutz et al, Journal of Psychopharmacology, Alcohol dependence
Cahart-Harris et al, The Lancet, Treatment-resistant depression
Ross et al, Journal of Psychopharmacology, Existential distress
Griffiths et al, Journal of Psychopharmacology, Existential distress
Treatment-resistant depression clinical trial
This summer we are beginning a randomised controlled trial of psilocybin therapy for treatment-resistant depression. This will be the largest clinical study of its kind and will take place in a number of clinical trial sites across Europe.
The trial is a phase IIb dose-ranging study with 216 patients. If successful, it will be followed by phase III studies in which we will look at comparing the optimal dose, mostly likely to placebo or standard of care.
We have received many enquiries about participation in our treatment-resistant depression trial. Please note that trial sites will only recruit patients who are referred by their healthcare provider (GP or psychiatrist).
The study coordinators at the trial sites will be contacting healthcare providers in their area once patient recruitment is underway. They will be able to discuss suitability for the trial in more detail.
The map below shows sites in countries where the team is already actively engaged in trial activities. We will update it progressively as more sites become active.
Healthy volunteer study
In conjunction with the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London, we are currently running a double-blind placebo-controlled phase I study with 90 healthy participants, aged between 18 and 65 years. The aim of the study is to assess the effects of two different doses of psilocybin versus placebo on cognitive and emotional function. It will involve simultaneous dosing of six participants in each session.
The participants will carry out a battery of computerised and paper tests over a 12-week period and will be supported throughout the study by trained therapists. They will be required to attend the centre on four occasions.
The study is due to finish in early 2019.
COMPASS is committed to developing new therapies that will help patients suffering with mental illness and ease the burden on healthcare systems.
We are actively exploring additional indications for psilocybin and at least two new substances, with a goal of bringing these to market over the next 5-10 years.
Our goal is to accelerate patient access to evidence-based innovation. We are interested in any innovation that might help those for whom existing treatments don’t work, whether that involves psychedelic drugs or not.
Investigator instigated studies using psilocybin supplied by COMPASS
We are keen to further research that will change mental health outcomes and help patients who have not been helped by other treatments. To support this, we work in collaboration with academic institutions and researchers around the world. We provide our cGMP (clinical Good Manufacturing Practice – the highest manufacturing grade) psilocybin to researchers at below cost price or for free, eg as part of the Medicines Chest programme of the European College of Neuropsychopharmacology (ECNP). We are looking at extending this approach to other eligible scientific associations and researchers with approved protocols.
For these investigator instigated studies, we also provide support in protocol development, through a project manager and input from our Scientific Advisory Board.
If you are interested in collaborating with COMPASS through an investigator instigated study, please contact us at email@example.com and we will be in touch to take you through the process and steps for set-up.
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Mindstrong Health delivers digital biomarkers of brain health. Its scientifically validated technology utilises content free, human-smartphone interactions to measure cognition and mood. We are working with Mindstrong Health on our treatment-resistant depression clinical trial to assess digital biomarkers as exploratory clinical endpoints.
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