Braxia Scientific presents positive preliminary findings from phase II randomized, multi-dose clinical trial of psilocybin-assisted therapy for treatment resistant depression
Braxia Scientific is a major 'player' in the Canadian psychedelic-assisted therapy world with several clinics already providing ketamine and (largely research-linked psilocybin) treatments. At the Toronto From Research to Reality conference at the end of last month, they presented "positive preliminary results from the first Health Canada Approved, Phase II, randomized clinical trial to evaluate the feasibility, safety, tolerability, and efficacy of multi-dose psilocybin-assisted therapy for Treatment-Resistant-Depression." They listed:
- Clinically meaningful improvements in depression severity observed (as measured by the MADRS1) with complete analysis of antidepressant efficacy and secondary outcomes pending. This trial will be completed by December 2022 at which point the full analysis will be completed and submitted for publication.
- Preliminary results indicate strong feasibility with adequate recruitment including 159 individuals who were referred to the study.
- Retention – 93% of participants retained to primary endpoint.
- Safety – No serious adverse events and zero suicide attempts to date.
- Tolerability – majority of adverse effects resolving within 24 hours of each dose and 87% of participants requesting to receive a second dose.
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