FDA Approves Clinical Trial Of Magic Mushroom's 'Psychedelic Ingredient' To Treat Depression
The Food and Drug Administration (FDA) approved the use of magic mushroom's "psychedelic ingredient" to treat depression. The federal agency allowed the life science firm Compass Pathways to conduct a drug trial on August 23 to see its effects on patients who were not cured by traditional medicines for the depressive disorder.
According to Talon Marks, there will be 216 patients that will participate in the said trial in Europe and North America that will start this September. Tracy Cheung revealed to Business Times China that there are no plans to reduce the treatment period this time and we will not be microdosing.
She added that "participants will receive synthesized psilocybin in a carefully controlled setting with two therapists/chaperones present throughout the entire session. Patients are then followed up over a 12 week period, but no further psilocybin is taken."
"Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people," Compass Pathways chairman and co-founder George Goldsmith said in a statement. "It is a huge unmet need, and the trial will teach us more about how this new approach might address it."
Fox Business reported a lot of psychedelic scientists has theorized the hallucination effect of the magic mushroom can help reboot the patient's brain. It will eventually result in a clearer mind that is free of any negative thoughts that cause depression.
Compass Pathways, on the other hand, talked about "psilocybin therapy," a dose of psilocybin, which is the combination of magic mushroom's psychedelic ingredient and psychoactive medicine. It revealed psychological support showed the use of it already displayed positive signs of effectiveness and safety as a treatment for depression in academic studies in the U.K. and the U.S.
Compass Pathways chief medical officer and co-founder Ekaterina Malievskaia assured the clinical study is a joint effort of scientists, clinicians, patient representatives, and regulators from all over the world. When the clinical trial becomes successful, the company shared it will conduct the phase III studies.
Compass Pathways is a London-based life sciences startup that started in 2016 under the backing of the billionaire Peter Thiel. He invested in the company with an undisclosed amount and one of its high-profile backers.