Scientific interest in the therapeutic potential of psilocybin – the active ingredient of “magic mushrooms” (which remain illegal in much of the United States, with some exceptions) has increased in recent years. Now, findings presented in a press release from a pharmaceutical maker indicate the compound might be a promising therapy for treatment-resistant depression – albeit with some serious side effects.
The findings add to a growing, though uncertain, body of research surrounding psilocybin’s effectiveness. While previous work indicates that it might offer a safe and effective alternative to traditional drug therapies for some mental health disorders, flawed features of study design have cast doubt on their conclusions. These include small sample sizes, failure to compare psilocybin to other drugs or placebos, and difficulties with blinding (shielding participants from information about which drug or dosage they are taking).
The recent trial addresses several of these issues with a sample size of 233 patients with treatment-resistant depression recruited across ten countries in North America and Europe. It also features the crucial element of double-blinding, a procedure that ensures neither the investigator nor the participant knows which treatment or dose is provided. Participants received one of three psilocybin doses: 25, 10, or 1 milligram (treated as an inactive dose, equivalent to a placebo) The study investigators then assessed participants’ depressive symptoms over time.
As early as two days after taking the highest dose of psilocybin, participants' depression scores markedly improved, an effect that endured up to six weeks. Twelve weeks after treatment, approximately 24 percent of high-dose recipients maintained an improved mental state compared to 10 percent from the “placebo” group.
These findings offer evidence that psilocybin might help treat severe depression. Nonetheless, the authors flagged several side-effects of high dosage, ranging from mild symptoms, such as headaches, nausea, and fatigue, to rare, but serious, adverse effects, such as suicidal ideations and self-harm. These severe symptoms affected 11 high-dose recipients, compared to just a single patient from the inactive dose group. The observation suggests potential cause for concern, and the FMF team looks forward to these preliminary results being discussed in greater detail in a peer-reviewed publication.
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