Sunstone Therapies Releases Encouraging Phase 2 Trial Findings For Major Depressive Disorder

Sunstone Therapies announced full results and methodology for its phase 2 clinical trial of psilocybin-assisted therapy to treat cancer patients suffering from major depressive disorder. The findings, published online in Cancer , the journal of the American Cancer Society, reveal that participants treated with psilocybin reported a notable reduction in depressive symptoms. Additionally, participants expressed positive views on the therapy during post-trial interviews.

This was a pioneering study which added to the growing body of evidence for the effectiveness of psilocybin-assisted therapy in tackling the mental distress experienced by patients with cancer and also, importantly, demonstrated the feasibility of a group and 1:1 patient-to-therapist ratio. Efficient, scalable delivery while maintaining safety is a key issue for psilocybin-assisted therapy and the results of this study suggest a pathway towards wider and faster adoption in the future.

Manish Agrawal MD, Chief Executive Officer and Co-founder, Sunstone Therapies

In the study, 30 adult participants with cancer and major depression received a single 25 mg dose of synthesized psilocybin. This was administered alongside individual therapy sessions and group therapeutic support. Participants, initially experiencing moderate to severe depression, demonstrated a significant average drop of 19.1 points in depression severity scores after eight weeks of treatment, indicating that the majority were no longer clinically depressed.

Moreover, 80% of participants exhibited a sustained response to treatment, with 50% achieving complete remission of depressive symptoms after one week, maintained for the entire eight-week period. Mild treatment-related side effects, such as nausea and headache, were reported.

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Participants noted that the group dynamic enhanced their experience, contributing to a sense of self-transcendence and mutual compassion. The combination of individual and group sessions was observed to support therapy in diverse ways, maintaining an intimate introspective process while fostering a sense of collective support.

Ultimately, the small-scale study suggested that by binding to a specific subtype of serotonin receptor in the brain, psilocybin induced alterations in mood, cognition, and perception. Despite its current classification as a Schedule I drug and lack of FDA approval for clinical use, multiple randomized controlled trials have demonstrated the safety and potential efficacy of psilocybin-assisted therapy. Sunstone Therapies’ approach combines psilocybin with psychological support from trained therapists to treat major depressive disorder.

Despite these promising results, the authors emphasize the need for additional studies with larger patient cohorts and control arms to compare effects with alternative treatments or placebos before considering implementation in clinical practice.

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