Clinical Trials
Psychedelic clinical trials are rapidly gaining momentum as researchers explore the therapeutic potential of substances like psilocybin, LSD, and MDMA. These trials involve carefully controlled settings where patients receive psychedelic treatment alongside psychotherapy. Early findings indicate significant promise in addressing conditions such as depression, PTSD, addiction, and anxiety. With increasing support and a growing body of evidence, psychedelic-assisted therapy is poised to revolutionize mental health treatment in the coming years.
Sample of companies undertaking clinical studies and one FDA approval
Compass Pathways PLC
Compass Pathways is developing a synthetic form of psilocybin, the main psychedelic compound in magic mushrooms. According to a recent phase 2b trial, Compass Pathways’ lead psilocybin treatment significantly reduced depressive symptoms by three weeks after a single dose. Patients given the highest dose also had benefits lasting for up to 12 weeks. Compass Pathways is following up the trial results in a phase 3 trial. The company is also testing the drug in other mental health conditions including PTSD, and supporting investigator-initiated studies in conditions including bipolar disorder, anorexia and major depressive disorder.
Eleusis
Eleusis undertook clinical trials in 2022 with an infusion of psilocin - the active form of psilocybin - which was expected to theoretically produce faster, less-variable results. Eleusis has developed a stable salt of psilocin that it plans to study in a Phase 1 trial.
Janssen
Johnson & Johnson’s Janssen Pharmaceuticals was the first US company to obtain US Food and Drug Administration approval in 2019 for Spravato, the mind-altering drug, for treatment-resistant depression. Spravato is a nasal spray that contains the S enantiomer of ketamine, an anesthetic and party drug also known as Special K. Patients typically get two treatments per week for 4 weeks and also take an antidepressant. Ketamine isn’t technically a psychedelic compound, but the approval lent credibility to the idea of using what is considered an illicit substance to treat intractable mental illness. The treatment was heralded as a breakthrough in a field that hadn’t seen innovation since the 1980s.