The trials will test the efficacy and safety of the investigational psilocybin therapy – made with a synthesized version of an active ingredient in magic mushrooms – across sites in the Czech Republic, Finland, Germany, the Netherlands, Portugal, Spain and the UK.
Psychedelic or ‘magic’ mushrooms contain various psychedelic compounds, including psilocybin.
Compass told us it is working with Worldwide Clinical Trials to implement a patient-centric approach.
“All our partners and suppliers have been involved in mapping out the full clinical trial process, thinking about the patient journey and patient impact at every step,” spokesperson Tracy Cheung told us.
The firm will educate patients prior to the trial, and will have trained therapists on-hand to accompany patients throughout the study, said Cheung.
“We have invested a great deal of effort in developing psychoeducational materials that will be shared online with prospective patients…this will help patients to learn more about psilocybin therapy and ensure that all patients are well prepared for the treatment session,” she added.
According to Compass, patient recorded outcomes (PROs) will help assess the efficacy and safety of the synthesized psilocybin product.
“Data will be entered by patients into an electronic portal on a tablet available at the investigational site,” Cheung told us, adding that all data will be consolidated for analysis and review.
Recruitment and psychoactive effects
Cheung said although the main challenge for a clinical trial is usually the recruitment of eligible patients, she believes this trial will attract sufficient numbers.
“We are offering a potential therapy for the indication where there is unmet medical need, so we believe interest will be high,” she told us.
According to Cheung, recruited patients will experience psychoactive effects, but will be under close supervision while undergoing the therapy.
“We are expecting trial patients to experience psychedelic – that is psychoactive effects – since psilocybin is a psychoactive drug,” she told us.
“Based on experience from previous studies, this might be a predictor of efficacy and improvement sustainability,” she added.
Patient recruitment will begin next year at a number of sites across Europe, the same year the firm hopes to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA), we were told.