Compass Pathways announced that data from an open-label phase 2 clinical trial of investigational COMP360 psilocybin in addition to daily selective serotonin reuptake inhibitors, or SSRIs, in treatment-resistant depression has been published online in the peer reviewed Nature journal, Neuropsychopharmacology. The exploratory phase 2 clinical trial used an open-label, fixed-dose design to investigate the safety and efficacy of a single dose of 25mg of COMP360 psilocybin with psychological support, in addition to an SSRI, in 19 participants experiencing treatment-resistant depression. The findings were first announced in December 2021. Response and remission was seen in 42% of participants at week three. The efficacy findings were similar to those from COMPASS’s Phase 2b study of 25mg of COMP360 psilocybin in treatment-resistant depression, where patients were withdrawn from their antidepressants prior to receiving COMP360. COMP360 psilocybin treatment was generally well tolerated. The most common treatment emergent adverse event was headache. No serious adverse events were reported.
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