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COMP006 Study - COMP360 (psilocybin) for treatment resistant depression

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Aims

In this research study, psilocybin is being tested for the treatment of treatment resistant depression (TRD) when administered with psychological support from a trained study therapist. COMP360 is a man-made form of the naturally occurring chemical compound, psilocybin. Psilocybin is found in some species of mushrooms, most commonly known as “magic mushrooms”. 

The main purpose of this study is to investigate how well two initial administrations of COMP360 psilocybin therapy works to lessen the severity of symptoms in TRD within the first 6 weeks of treatment when administered with psychological support and to determine the durability and long-term safety of COMP360 over approximately one year (55 to 62 weeks). The study will also be investigating the safety of COMP360 psilocybin therapy as well as how tolerable it is. 

Methods

A Phase III, multicentre, randomised, double-blind,controlled study to investigate the efficacy, safety,and tolerability of two initial administrations of COMP360 (psilocybin) in participants with treatment-resistant depression

Participants enrolled in this trial will be randomised to receive either 1mg, 10mg or 25mg of psilocybin. There will also be potential option to participate in an Open Label Extension, where all participants receive 25mg of psilocybin. 

Participating in the trial

If you wish to volunteer for this trial, please consider your decision carefully. There are strict inclusion and exclusion criteria the team cannot deviate from. You will be usually asked to attend the research facility on numerous occasions, without much flexibility for variation in dates. Clinical trials are not the same as receiving treatment from your doctor or therapist. We use placebos or variable doses in some of our trials. You may not get the treatment you want and the team is unable to change this, for any reason.

For one reason or another, most people who volunteer turn out not to be eligible for a clinical trial. It’s important to be realistic about the chances of inclusion and pursue other sources of help at the same time.

Effects of Psychedelics

Depending on the drug, psychedelic therapy lasts from about 2 to 8 hours. We only give people psychedelics in a dedicated hospital facility with support from doctors, nurses, psychotherapists and study coordinators. We don’t give people psychedelics to take home.

It isn’t possible to predict how psychedelics will affect an individual person. Clinical trials are an experiment. They are being done because we do not yet know if psychedelic therapy is a safe and effective form of treatment. Therefore, your participation in a trial comes with some risks. Your condition could improve, stay the same or it could worsen.Psychedelic therapy is not a ‘reset’ for your brain and it is not a ’quick fix’. Regardless of what happens, it’s important to have the right support around you if this happens. There are limits to the extent the study team can support you, particularly out of normal office hours.

Trials Design

Status

Recruiting

Participants

Adults

Clinical area

Treatment Resistant Depression

Intervention

Psilocybin therapy

Recruitment period

2024-2025

Contact

psilocybin@kcl.ac.uk

Funder

Compass Pathways

Sponsor

Compass Pathways

Our Partners

Project status: Ongoing
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Principal Investigator