The UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) has approved a trial investigating psilocin for major depressive disorder (MDD) that will be carried out in London.
The trial will investigate whether a novel psilocin prodrug – MSP-1014 – developed by Canadian pharmaceutical company Mindset Pharma Inc, can treat MDD when combined with therapy.
Its approval has been made against the backdrop of a mental health crisis in the UK, with one in four people in the country taking antidepressants for more than five years. Recent studies have estimated the cost of mental health problems to the UK economy at over £110bn a year.
Psilocin for major depression
Designed by contract research organisation Clerkenwell Health, the trial will be delivered in the company’s facility in London, near Harley Street, and will enable patients to stay on their antidepressants for the duration of the trial.
CEO at Clerkenwell Health, Tom McDonald, said: “We’re incredibly excited to be given the green light for this trial to explore an innovative treatment to a mental health condition which blights millions of people’s lives in the UK.
“Our work with Mindset is part of a suite of trials we’re planning to undertake in the next 12 months, to test the potential of psychedelics-related medicines for complex mental health and central nervous system conditions including alcohol use disorder and PTSD.”
Clerkenwell has stated that the trials will combine dosages of the psilocin-based drug with specialist therapy, delivered by therapists who have undertaken the organisation’s first-of-its-kind training programme for therapists delivering therapy in conjunction with psychedelic drugs.
Chief Scientific Officer of Mindset, Joseph Araujo, stated: “This is an exciting milestone as we prepare to enter our first-in-human clinical trial with our novel psilocin prodrug, MSP-1014.
“Based on pre-clinical data, we believe that MSP-1014 has the potential to be a better tolerated psychedelic therapeutic compared to psilocybin.
“This approval for a Phase II study should provide us with a strong efficacy signal and expedite our pathway to approval for MSP-1014 as a new effective and more tolerable treatment for patients suffering from MDD.”
MSP-1014 is anticipated to exert similar efficacy to psilocybin in improving symptoms of depression, and preclinical studies comparing the drug to psilocybin suggest that the tolerability of MSP-1014 may be superior to psilocybin.
