Novamind Begins Clinical Trial Of Psilocybin For Depression

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A smattering of small-scale studies provided researchers with encouraging evidence that psilocybin mushrooms could become a leading treatment for depression, but advancing the science has proved challenging in a strict regulatory climate that makes it difficult to study psychedelics on a larger scale.

Novamind Inc. NVMDF NM is contributing its expertise to that mission, announcing it is hosting a phase 2 psilocybin clinical trial sponsored by the Usona Institute.

The Phase 2 Psilocybin Trial May Represents An Important Step Forward For Psychedelic Medicine

The Usona Institute’s phase 2 clinical trial is recruiting 100 adults with major depressive disorder (MDD) who will be randomly split into a control group and a treatment group. The treatment group will receive 25 milligrams of psilocybin while the control group will receive 100 milligrams of the placebo niacin. 

The subjects’ depression symptoms will be scored before treatment using the Montgomery-Asberg Depression Rating Scale (MADRS) to get a baseline reading of how severe their symptoms are. They’ll come back periodically after the treatment to track their MADRS scores at weekly intervals with the goal of seeing a sustained reduction in symptoms of at least 50% at 43 days after treatment and, ideally, a total score of less than 10 out of a possible 60. 

Novamind randomized patients into control and treatment groups at its Draper, Utah, research site for the study, which will add important safety and efficacy data to the growing body of smaller-scale studies showing the potential of psilocybin to treat depression.

A meta-analysis published this year in the Journal of Affective Disorders reviewed the handful of small studies performed to date and found that early research points to a dose-dependent antidepressant effect of psilocybin. Higher doses lead to more significant decreases in depressive symptoms and longer-term results — meaning patients continue to enjoy less severe symptoms for months after treatment.

Because the studies were done on small groups, larger studies like the Phase 2 trial are needed to gather better data on dosing, efficacy, and safety. Once complete, if positive results from this study are received, it could push the field of psychedelic therapeutics forward.

Novamind Has A Strong Track Record In Psychedelic Research

With psilocybin still classified as a Schedule 1 drug, the most restrictive category in the Drug Enforcement Agency’s (DEA) controlled substances schedule, researching potential treatments using psychedelics is difficult. 

Researchers must apply to the DEA for licenses that allow them to store and study the substance as well as dose patients with it. This limits the number of players in the space, but Novamind received two DEA licenses last year, allowing it to move forward with psilocybin research such as the Phase 2 trial. During this trial, Novamind will gain experience working with the drug prior to approval, making them well-positioned upon anticipated FDA approval.

Novamind is a strong player in this emerging field thanks to its contract research organization. Novamind owns and operates a network of outpatient psychiatry clinics, which facilitates patient recruitment for its full-service contract research organization. Its CRO, Cedar Clinical Research, has the resources and expertise to execute the kind of large-scale studies needed to move psychedelic treatments closer to the market.

With its commercial model being compound agnostic, Novamind benefits from drug developers’ high R&D spend. It’s contracted with other leaders in the space like Merck & Co. Inc. MRK and Bionomics Ltd. BNOEF to research other novel treatments for depression, post-traumatic stress disorder, and other major and chronic mental illnesses in urgent need of more effective treatments.

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