Research & trials

We are motivated by the need to find better ways to treat and empower patients suffering with mental illness.

Psilocybin therapy

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.

1959
Sandoz

Sandoz chemist Albert Hofmann isolated and determined the structure of psilocybin

1961
Sandoz

Launch of Indocybin (psilocybin)

1965
Sandoz

Discontinued distribution of Indocybin due to misuse

1994

Strassman et al, Journal of Psychopharmacology, First significant psychoactive trial (Di-Methyl-Tryptamine or DMT)

60 participants
2006

Moreno et al, Clinical Psychiatry, Obsessive Compulsive Disorder

9 patients
2011

Grob et al, Archives of General Psychiatry, Existential distress

12 patients
2014

Johnson et al, Journal of Psychopharmacology, Tobacco dependence

15 patients
2015

Bogenschutz et al, Journal of Psychopharmacology, Alcohol dependence

10 patients
Jul 2016

Cahart-Harris et al, The Lancet, Treatment-resistant depression

19 patients
Dec 2016

Ross et al, Journal of Psychopharmacology, Existential distress

29 patients
Dec 2016

Griffiths et al, Journal of Psychopharmacology, Existential distress

51 patients

Treatment-resistant depression clinical trial

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.

Treatment-Resistant Depression active clinical trial sites
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Europe
University Medical Centre Groningen
University Centre for Psychiatry
Kings College London
Institute of Psychiatry, Psychology & Neuroscience
Greater Manchester Mental Health NHS Foundation Trust
Department of Psychiatry
Northumberland, Tyne and Wear NHS Foundation Trust
Wolfson Research Centre, Campus for Ageing and Vitality
University Medical Centre Utrecht
Department of Psychiatry, Affective & Psychotic Disorders

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.

Pipeline

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 select academic institutions and researchers around the world. We provide our cGMP (clinical Good Manufacturing Practice – the highest manufacturing grade) psilocybin to researchers free of charge, in exchange for the right to use safety data. Researchers are expected to cover packaging and shipping costs with our logistics provider.

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 info@compasspathways.com and we will be in touch to take you through the process and steps for set-up.

Research collaborations

We are bringing together innovators in digital health, technology and other fields to help us work more effectively and to learn more quickly.

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.

Calm gives our therapists access to meditation content and training.

7Cups has developed a training bot which is used by our therapists to develop and practise their active listening skills.