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
We are running a randomised controlled trial of Psilocybin Therapy for treatment-resistant depression. This will be the largest clinical study of its kind and is taking place in a number of clinical trial sites across Europe and North America.
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 (general practitioner 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 as more sites become active.
Expanded access policy
We are currently conducting phase IIb clinical trials of psilocybin therapy for treatment-resistant depression. We will not have the required preliminary efficacy and safety data to make a benefit-risk analysis until the end of this phase, at the very earliest, and so psilocybin is not yet available under compassionate use.
Click here to see COMPASS Pathways’ position on offering compassionate use of investigational medicines
COMPASS Pathways’ position on offering compassionate use of investigational medicines
COMPASS Pathways is a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health. Our first major initiative is developing Psilocybin Therapy, currently being evaluated in late-stage clinical trials in Europe and North America, for patients with treatment-resistant depression.
We conduct clinical trials to assess the safety and efficacy of investigational medicines which, if proven, will allow us to obtain the necessary approvals from regulatory authorities to provide patients with access to these medicines. We believe that participating in clinical trials is the best way for patients to access medicines prior to approval.
In some circumstances, when this is not possible, patients with diseases or conditions may seek special access to investigational medicines outside of a clinical trial setting. These situations are typically referred to as compassionate use, but can also be known as expanded access, early access, pre-approval access and emergency use.
Through the clinical development process, a drug is rigorously tested for safety and efficacy in humans; if proven, it is submitted to regulatory authorities for approval for sale, and then made available through healthcare systems to as many patients in need as possible, as quickly as possible. Because we do not know during the clinical development whether the investigational medicine is safe or effective, compassionate use may present risks for both the patient and the clinical development programme. For patients, compassionate use may bring potential safety risks or a false sense that the medicine will provide benefit; for the clinical development programme, it can delay or jeopardise the approval of a new medicine sought by many.
We are responsible for ensuring the quality and integrity of our clinical trials and for minimising any risks to participants and possible future patients. When considering compassionate use of an investigational medicine, we consider many factors, such as the strength of the clinical data, the benefit-risk profile, the impact on the clinical development programme, the phase of development, and the probability and timing of regulatory approval.
A compassionate use programme, or a single request for compassionate use of an investigational medicine, can only be considered if the following conditions are met:
• There are no adequate alternative therapies or clinical trials available
• Sufficient preliminary efficacy and safety data exist for the therapy to enable COMPASS Pathways to make a benefit-risk analysis consistent with the establishment of a compassionate use programme. This would not occur earlier than the end of Phase IIb studies, and depending on the clinical programme, potentially even later
• Sufficient clinical data is available to identify an appropriate dose
• A patient’s treating physician and COMPASS Pathways’ Head of Clinical Development both believe there is potential for the patient to reasonably expect benefit from the treatment, and there is robust evidence to support the possibility that the patient will benefit from it
• Adequate supply exists to support both the ongoing clinical trials and approved compassionate use, until and if the product becomes commercially available
• The patient is not eligible for any of the COMPASS-sponsored studies of the treatment. Geographic limitations to participation in a trial would typically not mean a patient is ineligible
• Compassionate access will not adversely impact the clinical development programme, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval
• The request must be made by the patient’s treating physician, unsolicited by COMPASS Pathways or any other individual or organisation
COMPASS Pathways will use the above criteria in consideration of whether to offer compassionate use. We cannot, however, guarantee that a compassionate use programme will be offered, and if it is offered, that the investigational medicine will be available to a particular patient.
Any pre-approval access to an investigational product must always comply with the applicable country-specific laws and regulations, including medicine importation requirements, and approvals must be secured from relevant regulatory bodies and the Institutional Review Board or Ethics Committee of the treating hospital.
For further information on our approach to compassionate use, please contact firstname.lastname@example.org.
Healthy volunteers study
In conjunction with the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London, we have completed a double-blind placebo-controlled phase I study with 89 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.
The study involved simultaneous dosing of six participants in each session. Participants were asked to carry out a battery of computerised and paper tests over a 12-week period and were supported throughout the study by trained therapists.
The study is due to report out shortly, and full results will be published later in the year.
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 email@example.com and we will be in touch to take you through the process and steps for set-up.
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