A Phase IIb study will be conducted in 2019 with 216 participants with treatment-resistant depression in 12-15 different research sites across Europe and North America.
The study will monitor dose-ranging. Participants must have failed two first-line anti-depressants to qualify as treatment-resistant.
Compass Pathways is using psilocybin as it's first innovation into finding treatment for patients with mental illness. The company will be working with the contract research organization (CRO) Worldwide Clinical Trials in this study.
Tracy Cheung, director of communications at Compass Pathways told us, “The research will be the largest ever clinical trial in psychoactive care. It follows a number of earlier academic studies which suggest that coupling psilocybin with psychological support provides immediate and sustained reductions in depression.”
Cheung said the study was designed as part of a collaborative effort involving consultation and discussion with scientists, clinicians, patients, and regulators to ensure the study was patient-focused.
The regulatory approval from the US Food and Drug Administration (FDA) means that the company can include US sites. The trial will be run across Europe, Canada, and the US. The study is set to begin in the United Kingdom at the end of August, and will be initiated in other countries following more regulatory approvals.
A study of psilocybin with healthy volunteers is ongoing at the Institute of Psychiatry, Psychology and Neuroscience at Kings College London.
Psilocybin is a psychoactive medicine, one of the two active ingredients in what is colloquially known as ‘magic mushrooms.’ As a therapy, psilocybin based medicine is given with psychological support. Research has shown “promising” results of efficacy and safety according to Cheung. The company has manufactured two batches of psilocybin to current good manufacturing practice (cGMP) standards already.
Unlike Selective Serotonin Reuptake Inhibitors (SSRIs), psilocybin inhibits serotonin-dependent neurons, which research believes increases emotional connection and “resets” the brain. The direct impact of Psilocybin is on the amygdala, where in high doses serotonin starved neurons can cause hallucinations along with distortions of time and perception of reality.