This is exciting...5-MeO-DMT just got FDA breakthrough designation for treatment resistant depression.
193 ppl with moderate-to-severe depression
38 sites
6 countries
Patients received either 12 mg (n=73), 8 mg (n=46), or a low-dose comparator of 0.3 mg (n=74), which served as a placebo control.
Efficacy Findings
+ at day 29 post-dosing, a single 12 mg dose reduced depression scores by 11.1 points (MADRS scale 0-60), compared to a 5.8-point reduction with the low 0.3 mg dose.
+ the 8 mg dose demonstrated equivalent efficacy, suggesting its potential sufficiency for therapeutic benefit.
+ effects of both 12 mg and 8 mg therapeutic doses were statistically significant compared to the low 0.3 mg dose, starting two days after treatment and peaking at 29 days post-treatment.
+ both 12 mg and 8 mg single doses exhibited durable effects, with mean depression score reductions of 10.2 and 10.8 points, respectively. Both were significantly greater than the 5.2-point reduction observed with the low 0.3 mg dose.
Safety Findings
+ 5-MeO-DMT was well tolerated at all doses, with over 99% of adverse effects being mild or moderate and no serious adverse effects reported.
+ dose related increases in nausea, headache, blood pressure, and anxiety suggest the 8 mg dose was better tolerated than the 12 mg dose.
+ no suicide-related safety signals or concerns were observed.
+ most treated patients were deemed ready to go home within 90 minutes of treatment
Findings from the phase 2a open-label study, using 12 mg and 8 mg doses spaced two weeks apart, showed similar results. These included a rapid decrease in depression score by day 2, maximal improvement at day 22, with a durable effect lasting over 12 weeks of follow-up.