A new study is presenting the first published data from preliminary human trials investigating the effect of psilocybin-assisted psychotherapy to treat major depressive disorder (MDD). The incredibly positive results have been described as just a “taste of things to come” with larger a Phase 2 trial well underway.
The US Food and Drug Administration (FDA) has granted psilocybin, the primary psychoactive compound in magic mushrooms, a Breakthrough Therapy designation on two occasions over the past 24 months. Initially the designation was granted to help accelerate trials for severe treatment-resistant depression, but more recently the classification focused on trials for major depressive disorder.
effectively to at least two different pharmacological antidepressant treatments during a current depressive episode.
MDD is much more common, with some estimates suggesting over 300 million people worldwide suffer from the debilitating condition. While a larger Phase 2 trial testing psilocybin for MDD is currently underway, this new study, in the journal JAMA Psychiatry, offers the first peer-reviewed published data showing efficacy for this particular mental health condition.
This small preliminary trial recruited 24 subjects with at least two-years documented history of depression. All subjects were required to wean off any anti-depressant treatment before the trial commenced.
Depression was assessed using the standard GRID-Hamilton Depression Rating Scale. Severe depression scores 24 or higher on the scale, while seven or less is classified as no depression. At the beginning of the study the average score for the cohort was 23.
The treatment process resembled the general protocol used in most psilocybin studies. Two doses of psilocybin were administered to each subject, spaced two weeks apart. A number of psychotherapy sessions both preceded and followed the active psilocybin sessions.