Magic mushrooms found to be effective in treating serious depression

A mental health care company dedicated to accelerating patient access to evidence-based innovation announced that its groundbreaking clinical trial of psilocybin therapy has found that a 25mg dose of magic mushrooms is effective for treatment-resistant depression.

Compass Pathways revealed the psychedelic drug was highly efficacious as a therapy “demonstrating a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response.”

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

The study is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III program, which Compass expects to begin in 2022.

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges. It combines the pharmacological effects of psilocybin, a psychoactive substance, with psychological support.

Psilocybin is an active ingredient in some species of fungi—often referred to as ‘magic mushrooms’— due to the hallucinogenic psychedelic experience they induce.

Compass developed a synthesized formulation of psilocybin, COMP 360, and the company is investigating the effectiveness of psilocybin therapy in treatment-resistant depression.

Early studies conducted in pioneering academic centers have shown signals that psilocybin could be a safe and effective medicine for patients with depression, anxiety, addiction, and other mental illnesses, when administered with psychological support from specially-trained therapists.

“No one is untouched by the mental health crisis – everyone has a story,” said Compass Pathways CEO George Goldsmith. “We urgently need options for people who are not helped by existing therapies. We set out to explore the safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression, through a rigorous and large-scale trial, and to find an appropriate dose to take to the next stage.”

“I am delighted that we have succeeded in doing this. We have demonstrated our ability to execute an innovative, multicentre, multinational clinical trial program – and in the midst of a global pandemic,” said Goldsmith. “Our work follows the efforts and achievements of so many researchers before us, and we are grateful to all of them and for the opportunity to work with the mental health care community to transform patient experience and patient outcomes.”

“With our world-leading psychedelic research over the last few years, we have now created a unique and extensive data lake; this provides an unprecedented opportunity to further evaluate and optimize psilocybin therapy for patients suffering from serious mental health illness,” said Goldsmith. “With these compelling data, we will urgently progress our clinical development program and move closer to making this therapy accessible to patients in need, if approved.”

Due partly to restrictions of the Controlled Substances Act in the United States, research had been frozen until the early 21st century when psilocybin mushrooms were tested for their potential to treat drug dependence, anxiety and mood disorders.

In 2018, the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for studies of psilocybin in depression disorders.