Psilocybin Study

Information for clinicians

About psilocybin

Psilocybin is a naturally occurring chemical found in several species of mushrooms, sometimes referred to as ‘magic mushrooms’. It is one of a group of drugs known as ‘psychedelics’ which are being studied as potential treatments for several mental health conditions including depression, anxiety, OCD, and addiction.

Over 2,000 psilocybin sessions have been conducted in modern scientific studies in patients and healthy volunteers. Hundreds of patients were treated with psilocybin in the 1950s and 60s1. A recent preliminary small-scale open-label study2 in 20 patients with treatment-resistant depression demonstrated significant reductions in depressive symptoms at all measured timepoints after baseline. In this study, symptom improvements appeared rapidly after just two psilocybin treatment sessions and remained significant six months post-treatment. In October 2018, the FDA3 gave Breakthrough Therapy status to COMPASS Pathways’ programme of psilocybin therapy for treatment-resistant depression. The FDA designates a programme as a Breakthrough Therapy if preliminary clinical evidence shows that it may demonstrate substantial improvement over available therapy.

The study

Newcastle is taking part in a worldwide multi-centre study investigating the effects of psilocybin in treatment-resistant depression. The study is sponsored by COMPASS Pathways and listed on clinicaltrials.gov.

The study will analyse the effects of a single administration of psilocybin at three doses (1mg, 10mg, 25mg) in 216 patients. All patients on antidepressants must taper off them within 3-6 weeks prior to baseline (the study team will manage this). The study includes 13-16 visits, two of which can be done remotely, over a 15-18 week period. A specially trained study therapist will support every participant before, during and after the psilocybin session.

How to refer a patient

Only patients who have tried two, three or four anti-depressants without success for their current episode of depression are eligible for this trial. If single episode, it must be more than 3 months but less than 2 years.

Patients interested in joining this trial who satisfy the eligibility criteria below need to be referred by their physician in order to be considered for the study.

Eligibility criteria:

  • 18 years or older
  •  Failure to respond to 2, 3 or 4 pharmacological treatments for current episode of depression
  • At least moderate Major Depressive Disorder (single or recurrent episode as defined by DSM-54; if single episode, duration of 3 months and 2 years)

Exclusion criteria:

  • Current, or history of, psychosis, schizophrenia, personality disorders, or bipolar disorder
  • Depression secondary to other medical condition
  • ECT5 or ketamine for current episode
  • High risk of suicide
  • Alcohol or drug abuse in the last year
  • Cardiovascular conditions, such as myocardial infarction, in the last  year
  • Seizure disorder
  • Uncontrolled insulin dependent diabetes

If you have a patient who may be suitable or would like more information, please contact: Anna Massey; anna.massey@cntw.nhs.uk; 0191 208 1362.


1Nichols et al (2016);2Carhart-Harris et al (2017);3US Food and Drug Administration;4Diagnostic and Statistical Manual of Mental Disorders;5Electroconvulsive therapy