Psilocybin could be a promising therapeutic strategy for people with treatment-resistant depression

Psilocybin could be a promising therapeutic strategy for people with treatment-resistant depression

Researchers at Trinity College Dublin have taken part in the largest and most rigorous clinical trial to date of psilocybin (a psychoactive ingredient in magic mushrooms), raising the possibility that COMP360 psilocybin, with psychological support, could be a beneficial therapeutic strategy for people with treatment-resistant depression (TRD).

The study will be published tonight in the prestigious New England Journal of Medicine (NEJM) [9 pm, Wednesday 2nd November 2022]Here: http://www.nejm.org/doi/full/10.1056/NEJMoa2206443

Based on promising preliminary results, this funded multicenter, randomized, double-blind Phase 2b clinical trial was initiated in 2018 to determine the safety and potential antidepressant effects of a single dose of COMP360 psilocybin (25 mg or 10 mg) compared to 1 mg, with psychological support in people with TRD. The study was sponsored by COMPASS Pathways, a UK-based mental health company that also developed COMP360 – their proprietary formulation of synthetic psilocybin administered in conjunction with psychological support.

The study, which involved 233 people with TRD in 10 countries, including the Irish site of Tallaght University Hospital, showed that patients who received a single 25 mg dose of COMP360 psilocybin experienced a highly statistically and clinically significant rapid reduction in depression symptoms compared to 1 mg after 3 weeks (p < 0.001). This provides hope that COMP360 psilocybin with psychological support could be an effective antidepressant treatment paradigm for some people with TRD if proven effective and safe in larger studies. COMPASS Pathways will conduct a larger Phase 3 program of COMP360 psilocybin therapy in TRD, scheduled to begin in 2022.

Important research results

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• 25 mg COMP360 Psilocybin mit psychologischer Unterstützung führten zu einer statistisch und klinisch signifikanten Verringerung der Depressionssymptome bei Menschen mit TRD im Vergleich zu 1 mg in Woche 3.
• 37 % der Personen mit TRD in der 25-mg-Gruppe erfüllten die Kriterien für das Ansprechen in Woche 3 (≥ 50 % Abnahme der depressiven Symptome).
• Ungefähr 30 % der Menschen mit TRD in der 25-mg-Gruppe erfüllten die Kriterien für eine Remission in Woche 3 (29,1 %).
• 20 % der Menschen mit TRD in der 25-mg-Gruppe erfüllten die Kriterien für ein anhaltendes Ansprechen in Woche 12.
• COMP360 Psilocybin wurde im Allgemeinen gut vertragen.

This is the largest and most rigorous clinical trial of psilocybin to date. It shows a promising antidepressant signal for 25 mg COMP360 psilocybin with psychological support and has paved the way for Phase 3 clinical trials that will determine whether it will translate into a much-needed complementary treatment strategy in the psychiatric clinic.

We look forward to the Phase 3 trial and to developing a translational psychedelic science research program at Trinity College Institute of Neuroscience and Tallaght University Hospital. Ultimately we hope this will bring tangible benefits to patients, the healthcare system and Irish society.”

Dr. John R. Kelly, Psychiatrist and Clinical Lecturer, Trinity College

Source:

Trinity College Dublin

Reference:

Goodwin, GM, et al. (2022) Single dose of psilocybin for a treatment-resistant episode of major depression. New England Journal of Medicine. doi.org/10.1056/NEJMoa2206443.

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