Author: Kara Grant, Corporate and Research Writer, MedPage Today November 10, 2021

The drug maker Compass Pathways announced in a press release that in a randomized phase IIB study, the drug compound Psilocybin found in the "magic mushroom" reduced the symptoms of drug-resistant depression, but was associated with some serious adverse events (AE).

In a trial of more than 200 patients who stopped taking antidepressant drug resistance treatment before enrollment, a 25 mg dose of COMP360 psilocybin and continued psychological support resulted in a Montgomery-Åsberg depression scale of -6.6 points The difference (MADRS) total score at week 3 was compared with the group receiving the 1 mg dose (P <0.001), and the difference was still significant during week 6.

The third group of the study tested a 10 mg dose of psilocybin, but this showed no statistically significant difference compared to the 1 mg dose at week 3 (-2.5 points P=0.184). The test results have not been peer reviewed.

In the 25 mg group, 29.1% of patients achieved remission (the total MADRS score decreased by ≥50% from baseline) in the 3rd week, compared with 7.6% in the 1 mg group. By week 12, these rates were 24.1% and 10.1%, respectively.

"The remission rate seems to be higher than that seen in traditional drug research," said David Hellerstein, MD, lead researcher at Columbia University in New York City in a statement. "These findings indicate that, if approved, the COMP360 psilocybin therapy can play an important role in psychiatric care."

In an investor conference call where the Compass leadership presented the findings, Guy Goodwin, MD, the company’s chief medical officer and professor emeritus of psychiatry at Oxford University, stated that the results of the 25 mg group “show evidence of the persistence of the psilocybin response” treatment.

However, the underlying concern is that higher psilocybin doses lead to a higher incidence of serious adverse events (AE) during treatment. These serious AEs—including suicidal behavior, suicidal ideation, and deliberate self-harm—occurred in 5 patients (6.3%) in the 25 mg group and 6 patients (8.0%) in the 10 mg group, as compared with those in the 1 mg group. Compared to one patient (1.3%).

Dr. Matthew Johnson, professor of psychiatry and psychedelics at the Johns Hopkins School of Medicine in Baltimore, told MedPage Today that early data looked encouraging. However, in the absence of more detailed information, questions about the nature of experimental AEs still exist, he said.

"When working with people with depression, these symptoms will appear with the territory. Suicidal behavior can cover a wide range, from fleeting thoughts to more serious plans," Johnson said. "Effective treatment may put people in a more difficult psychological situation when dealing with experiences, just like dealing with trauma. The treatment itself can bring very difficult emotions and may make things worse in the short term."

He explained that since there is no further detailed information on the suicidal tendencies reported by the patients, it is difficult to fully evaluate them.

Lars Christian Wilde, the co-founder and president of Compass, said on an investor conference call that the difference in the frequency of severe AEs was not statistically significant between the dosing groups. He pointed out that among people suffering from treatment-resistant depression, suicidal thoughts, self-harm and even suicidal behavior are also common.

According to the UK-based company, this study is the largest study ever to test the compound and included 233 patients with treatment-resistant depression. Patients were randomly assigned to three doses of COMP360 psilocybin at a ratio of 1:1:1, and received continuous psychological support from the therapist. Participants came from 10 countries in North America and Europe. It is worth noting that 94% of patients have no previous experience with psilocybin.

Overall, 179 patients reported experiencing at least one AE during treatment, and more than 90% of patients were in the mild to moderate category (83.5% in the 25 mg group, 74.7% in the 10 mg group, and 72.2%, the company noted , In the 1 mg group).

The company's researchers plan to start a phase III trial next year, which may focus on the 25 mg dose. The leadership team also announced that the company will launch a phase II trial of psilocybin for the treatment of post-traumatic stress disorder.

Kara Grant joined MedPage Today's corporate and investigative reporting team in February 2021. She is responsible for psychiatry, mental health and medical education. follow

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