The British company Compass Pathways released on Tuesday (9) preliminary results of the largest clinical trial on psychotherapy with psilocybin for treatment-resistant depression. 209 of the 233 patients recruited from centers in ten countries (US and Europe) completed the study.
The announcement of Compass, a firm shrouded in controversy, came as a statement to investors and the press, and not as a publication in a scientific journal after critical analysis by experts (“peer review”). Not by chance, it was done on the same day the company published financial results for the third quarter of 2021.
In the test, patients were divided into three groups, which received 25mg, 10mg or 1mg, respectively, of the substance originally obtained from so-called “magical” mushrooms. The aim of this phase 2 trial was to establish the optimal dose for the phase 3 clinical trial that Compass plans to start in 2022 to gain treatment approval perhaps as early as 2024.
The statement highlights that 36.7% of participants in the 25mg group had a positive response after three weeks, that is, decreased symptoms of severe depression on the standardized MADRS scale. By comparison, among those taking the nearly innocuous 1mg dose, only 17.7% had the same response, a statistically significant difference.
Furthermore, 29.1% were in remission in the first contingent, against 7.6% in the second. For the intermediate dose (10mg), there were no results with statistically relevant differences.
“This is an important and exciting time for the mental health care community,” neuroscientist Robin Carhart-Harris, a star of psychedelic science who moved from Imperial College London to the University of California, San Francisco, said in the Compass statement. . Carhart-Harris led two pioneering studies of psilocybin for depression at Imperial College, the first without a control group and the second, published in April, comparing it to the antidepressant escitalopram (Lexapro).
“[O estudo da Compass] builds on more than two decades of research into the feasibility of psychedelic compounds to treat mental health conditions and demonstrates the potential they have to help people living with resistant depression [a tratamento]. It is encouraging to see how this field has progressed over the past 20 years, and I look forward to continuing the research.”
Nine out of ten records of adverse effects during the experiment were considered mild, such as headaches, nausea, insomnia and fatigue. But there were 12 patients with more serious side effects, such as suicidal ideation and behavior — not uncommon occurrences in these patients, as up to a third of the 100 million people in the world with resistant depression try to commit suicide at least once in their life.
Compass faces resistance from the psychedelic community for its intellectual property-based business model on the healing power of a substance that has been used for centuries by traditional communities and alternative clinics. Open science supporters question the five patents already granted to the company in the US.
A portal was even created with information to supply national intellectual property offices (Porta Sophia), in the expectation that its employees will recognize the lack of originality. In the US state of Oregon, psilocybin-assisted psychotherapy is in the regulatory stage, without waiting for approval from the FDA (US drug agency).
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