What did we learn from the largest psilocybin trial?

10th November 2021

While the use of psychedelics and the development of psychedelic-based medicines and therapies are on the rise, evidence around how they work and affect us is still relatively under-researched, thanks to decades of prohibition.

However, the recent publication of the results from the largest psilocybin study ever completed may help us to better understand the potential of this substance.

Compass Pathways has revealed that these results demonstrated a “rapid and sustained response” for patients receiving a psychedelic-based medicine.

According to the company, the medicine could reduce symptoms of treatment-resistant depression after three weeks, making it a potentially useful therapeutic option for the treatment of the condition.

What is psilocybin?

Psilocybin is a psychedelic substance that is found in a small number of fungi, often referred to as ‘magic mushrooms’.

These mushrooms have become well-known, however for the past half-decade, they have largely been associated with recreational drug use, hippy culture and anti-establishment groups.

There is comparatively little awareness of the health and therapeutic potential of the substance.

About treatment-resistant depression (TRD)

More than 320 million people globally suffer from major depressive disorder (MDD), the leading cause of disability worldwide and one of the fastest-growing mental health illnesses.

About a third of these patients – roughly 100 million people – aren’t helped by existing therapies and suffer from treatment-resistant depression (TRD).

TRD carries two to three times the medical costs of the treatment of non-TRD MDD, and patients with TRD have higher all-cause mortality compared with non-TRD MDD patients.

So what did the study say?

In this recent randomised, controlled, double-blind trial, a single dose of investigational psilocybin-based medicine was given to 233 patients in conjunction with psychological support from specially trained therapists.

The trial aimed to compare two active doses of COMP360, the medicine, 25mg and 10mg, against 1mg dose of a comparator.

The results are telling: the 25mg group vs the 1mg group – basically the placebo group – showed a -6.6 difference on the Montgomery-Asberg Depression Rating Scale (MADRS) depression scale at week three.

However, there was no real difference between those given 10mg of COMP360 and 1mg comparator.

Furthermore, almost a third (29%) of the 25mg group reported some sort of remission after three weeks – with almost a quarter of the same group still in remission 12 weeks after administration.

These are promising results, to say the least.

David J Hellerstein MD, a Principal Investigator on the trial and Professor of Clinical Psychiatry at the Columbia University Irving Medical Center, said: “Treatment-resistant depression is a common and devastating condition, affecting tens of millions of people, with few effective treatments.

“This is the largest modern study of a psychedelic drug, combined with psychological support, enrolling over 200 people with TRD. In this groundbreaking study, a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks.

“Remission rates appear to be higher than seen in traditional medication studies. We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder.

“These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care if approved.”

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