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.
Over the last few years promising preliminary research has shown psilocybin to potentially be effective in helping terminal cancer patients manage end of life anxiety. Initial psilocybin trials focusing on depression concentrated specifically on treatment-resistant depression – a clinical classification that categorizes patients suffering from MDD who have not responded 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.
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.
“The magnitude of the effect we saw was about four times larger than what clinical trials have shown for traditional antidepressants on the market,” says Alan Davis, from the Johns Hopkins University School of Medicine and corresponding author on the study. “Because most other depression treatments take weeks or months to work and may have undesirable effects, this could be a game changer if these findings hold up in future ‘gold-standard’ placebo-controlled clinical trials.”