About psilocybin therapy
Psilocybin therapy is a new approach that is currently being investigated for the treatment of mental health challenges. It combines the pharmacological effects of psilocybin, a psychoactive substance, with psychological support.
Psilocybin is an active ingredient in some species of mushrooms, often referred to as ‘magic mushrooms’. In order to investigate the effects of psilocybin as a potential treatment for depression and other illnesses, we have synthesised the compound to the highest regulatory standards in our psilocybin product, COMP360.
Early studies conducted in pioneering academic institutions have shown signals that psilocybin could be safe and helpful to patients with depression, anxiety, addiction and other mental illnesses, when administered with psychological support from specially trained therapists. This psychological or psychotherapeutic support consists of several preparation meetings with a dedicated therapist; support in the psilocybin therapy session itself; and integration sessions following the psilocybin experience. The timeline below shows some of the key developments in psilocybin research in the last few decades.
Watch our video on the importance of room setting in
clinical trials of psilocybin therapy
Preparation: the goal of the preparation sessions is for the therapist and a patient to get to know each other and to form a trusting relationship, so a patient feels fully supported during the psilocybin session. The psilocybin session: lying down in a comfortable, specially designed room, patients receive a dose of psilocybin, whilst supported throughout by a trained therapist. During the experience patients listen to a specially designed music playlist whilst wearing an eye mask, to help them focus internally. The psilocybin experience normally lasts between 6-8 hours. Integration: this is where patients discuss their experiences of the psilocybin session; the main goal of the integration is for patients, with support from a therapist, to generate their own insights and solutions that could lead to changes in unhelpful emotional and behavioural patterns. Previous research and experience of our therapists shows that the quality of psychotherapeutic support is as important as any psychopharmacological effects of psilocybin, and so all therapists in our research studies are carefully trained through an FDA-approved program. To learn more about our Therapist Training Programme please click here
What happens before, during and after a therapy session?
What happens before, during and after a therapy session?
Preparation: the goal of the preparation sessions is for the therapist and a patient to get to know each other and to form a trusting relationship, so a patient feels fully supported during the psilocybin session.
The psilocybin session: lying down in a comfortable, specially designed room, patients receive a dose of psilocybin, whilst supported throughout by a trained therapist. During the experience patients listen to a specially designed music playlist whilst wearing an eye mask, to help them focus internally. The psilocybin experience normally lasts between 6-8 hours.
Integration: this is where patients discuss their experiences of the psilocybin session; the main goal of the integration is for patients, with support from a therapist, to generate their own insights and solutions that could lead to changes in unhelpful emotional and behavioural patterns.
Previous research and experience of our therapists shows that the quality of psychotherapeutic support is as important as any psychopharmacological effects of psilocybin, and so all therapists in our research studies are carefully trained through an FDA-approved program. To learn more about our Therapist Training Programme please click here
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
We are running a comprehensive large-scale clinical development programme of psilocybin therapy for depression, including a phase IIb study for treatment-resistant depression, which is taking place across Europe and North America. For more information on our clinical trial, see ‘Our clinical trials’ below.
About treatment-resistant depression
‘Treatment-resistant depression’ (TRD) is a term used when people with depression do not respond adequately to at least two different anti-depressant medications.
Depression is the leading cause of disability and ill health worldwide. Up to two-thirds of people with depression do not respond to the first antidepressant medication they try. Up to a third of people with depression do not respond to multiple attempts at treatment.
Our clinical trials
Treatment-resistant depression study
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.
I suffer with depression
I suffer with depression
Recruitment to this trial is managed directly by the research teams at our trial sites, who work with specific eligibility criteria. In particular, only people who have tried two, three or four anti-depressants without success in the last two years could be eligible to join – and this would need to be verified by your physician. If you think you might be eligible, please contact a study centre near you – locations are listed on the map below.
It may be possible to receive treatment at a site in a country other than that where you live, but this can be very complicated to organise and is up to the site to agree. All applicants need to speak the national language of the country where the trial takes place. In addition, due to the number of face-to-face clinic visits required, applicants should ideally live within one to two hours of the site, unless special provisions have been made.
I am a clinician
I am a clinician
Only people who have tried two, three or four anti-depressants without success in the last two years could be eligible for this trial. If single episode, it must be more than 3 months but less than 2 years. People interested in joining this trial who satisfy the below eligibility criteria need to be referred by their physician in order to be considered for the study. If you have a patient who may be suitable, please contact a study centre near you. Locations are listed on the map below, or visit ClinicalTrials.gov for a list of contact details.
Who is eligible for this study?
Has your patient tried two, three or four anti-depressants without success in the last two years? If so, they could be eligible for this study.
Where is the study taking place?
The map below shows where our study is taking place. We will update it as more centres join. Please click on the map to find contact details for centres near you.
Our randomised controlled trial is a phase IIb dose-ranging study with 216 patients.
For further details on the clinical trial sites, including contact details, please visit: ClinicalTrials.gov
Healthy volunteers study
In conjunction with the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London we ran a phase I, double-blind placebo-controlled study with 89 healthy volunteers, aged between 18 and 65 years.
Initial results of the study were presented at the ACNP 2019 annual meeting (see poster). The results showed that psilocybin was well-tolerated when administered to healthy adult volunteers with support from specially trained therapists (click here to read our press release).
Expanded access policy
We are currently conducting a phase IIb clinical trial 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 our 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
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.
Our therapist training programme
Our Therapist Training has been designed by leading experts from the fields of psychology, psychiatry and psychedelic therapy research, and approved by FDA for research purposes.
Our primary focus is to provide the best quality care for patients by creating a dynamic learning environment in which therapists can share and build their knowledge of psilocybin therapy, under the guidance of our experienced trainers.
We require all our therapists to have specific professional and educational backgrounds, which have been approved by the FDA and European regulators: all therapists must be registered mental health professionals with at least Masters level of education, such as mental health nurse practitioners, clinical psychologists, and psychiatrists with experience in counselling or psychotherapy.
Our programme comprises several tiers which must all be completed before therapists in training can lead our psilocybin research sessions:
- Self-paced online learning on our Shared Knowledge Platform, that includes over 20 hours of didactic materials, video lectures by leading experts, re-enactments of common clinical scenarios from psilocybin sessions, a Psilocybin Therapy Manual approved by the FDA and many other useful resources
- In-person 5-day interactive training in small groups of 10-12 therapists, focusing on role plays and feedback, lead by our own dedicated trainers
- Clinical training under the guidance of an experienced psilocybin research therapist: all therapists are required to be present in at least 4 psilocybin sessions before they can lead the sessions independently. The opportunity to sit in psilocybin session is provided through our academic partners, including The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London, Sheppard Pratt Health System and selected other academic centres with several ongoing psilocybin studies. Our therapists consider this to be the most challenging, yet the most useful part of the training programme
- Continuous professional development: ongoing 1:1 supervision, fidelity rating and feedback sessions with a dedicated mentor: monthly webinars with the community of therapists and trainers focusing on clinical case studies – these additional steps aim to ensure the delivery of quality psychological support
As we expand our knowledge-base of psilocybin therapy, we are constantly improving the therapeutic model and training programme so that it is evidence-based and high quality. At present, our training programme is only available to therapists involved in our studies or investigator-initiated studies that use our compound. In the future, we look forward to welcoming a larger pool of mental health professionals into our training programme, so that more patients can have better access to evidence-based care.
We are keen to further research that will change mental health outcomes and help those 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 with regulatory submissions.
If you are interested in working with COMPASS through an investigator-instigated study, please contact us at email@example.com.
Collaboration is key to developing a new approach to mental health, and this is why we are bringing together health innovators for the benefit of patients.
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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.
Our research and development
We are committed to developing new innovative therapies that help people suffering with mental health conditions and ease the burden on healthcare systems. We are actively exploring additional indications for psilocybin and other new compounds.