Compass pathways’ phase 2B… breakthrough therapy designation by the US FDA in late 2018… delivers mixed results
…a 35-percent response rate and a 5-percent SAE rate means for every seven patients positively responding to the treatment, one person will experience serious negative outcomes… these serious adverse events included suicidal ideation and suicidal behavior.
Five patients (6.3 percent) in the 25-mg group and six patients (8 percent) in the 10-mg group experienced at least one serious adverse event in the follow-up period after the psilocybin treatment. This compared to just one serious adverse event reported in the 1-mg placebo group.
Original Article (New Atlas):
Largest psychedelic therapy trial to date delivers mixed results
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