World’s First Phase 3 Clinical Trial for Psilocybin Set to Begin

Psychedelic therapy has been around for millennia, with cultures all over the world embracing its potential benefits until quite recently, actually. The American drug ban in 1971 classifies the majority of psychedelics as Schedule I substances or substances with no medicinal benefit. Because of this, research has either slowed or altogether halted on the subject. In fact, no studies have made it past stage 2… until now.

Compass Pathways And The Future Of Psychedelic Therapy

According to Compass Pathways, the world’s first Phase 3 human trial for day psilocybin therapy with psychological support will begin by the end of 2022. The trial will enroll nearly 1,000 people, and Compass hopes to receive FDA approval by the end of 2025.

This news follows the success of their 2B trials which took place late last year. The research involved 233 patients with treatment-resistant depression who were randomly assigned one of three psychedelic doses: 25 mg, 10 mg, or 1 mg. Compass reported statistically significant improvements after a single 25 mg psilocybin dose over a 12-week follow-up when compared to the lower doses.

Following discussions with the FDA, Compass has decided to release its plan for Phase 3, the first clinical study of its kind.

Phase 3

Phase 3 will focus on studying individuals with treatment-resistant depression, or those with severe depression who have not responded to antidepressants or psychotherapy.

This trial, like most psychedelic clinical research, will employ pre- and post-drug psychotherapy. However, the therapy component of Compass’ protocol is significantly reduced when compared to other psychedelic-assisted therapy trials that use more comprehensive therapeutic oversight.

Pivotal 1

Pivotal 1, the first Phase 3 trial, plans to enroll 378 participants to compare a single 25 mg psilocybin dose to a placebo. The use of a placebo control differs from the Phase 2B design, which tested three different doses.

Despite concerns about using a placebo, 2B trials which took place late last year, Compass Pathways’ chief medical officer, stated that the use of a placebo control in Pivotal 1 is intended to help clarify psilocybin’s safety profile.

Pivotal 2

The second phase of the Phase 3 program, dubbed Pivotal 2, more closely resembles the tiered approach of 2B and is attempting to recruit 568 participants. However, the goal here is to investigate the efficacy of a second psilocybin dose administered three weeks after the first dose. According to Goodwin, one of the main reasons for Pivotal 2’s two-dose design is to see if two 10-mg doses are effective at reducing depression symptoms. 2B revealed that 25mg doses were more effective on initial consumption, but benefits of the lower doses were detected in the follow-up period, hence Pivotal 2.

After The Study

The primary endpoint of the Phase 3 trial is a reduction in depression as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) six weeks after the first drug dose. While the long-term efficacy of this type of psychedelic-assisted psychotherapy treatment is unknown, Compass Pathways believes that some patients may require two to three psilocybin doses per year to maintain the positive effects of treatment.

Compass anticipates that the first wave of data from Pivotal 1 will arrive in late 2024. And applications to the FDA for market approval could be made as soon as the following year. So, if the trial is successful, this could be the clinical evidence needed to approve psilocybin treatment.

This is a super exciting development in psychedelic drug therapy. We’re excited that the FDA is allowing Compass to proceed with the trial, and we hope for some scientific evidence of the benefits of psychedelics to come out soon.

The results of this study are sure to be interesting, and we’re looking forward to reading them.

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