“According to the researchers, only 20 randomized, controlled trials of ketamine for depression exist—and of these, most were “proof-of-concept” studies that used only a single dose and did not include follow-up. Altogether, these studies included 430 participants exposed to ketamine. Especially distributed across 20 studies, this number is considered very small when attempting to draw significant, generalizable conclusions about efficacy.” And one offs are considered science or worst yet, an experiment? And 1 suicide out of 430 participant with mostly one dose? My next question is how many doses did the participants have to take overall? Did anyone consider this a public safety risk? Dr Littrell brings up a fantastic point and the most anticipated side effect of this drug is psychosis. I would love to see the error band on that side effect, never mind what P comes out to or worst yet, what the confidence intervals are for psychosis. I am really wondering what the Murphy Act has/has on this approval process. I know that a lot were concerned about the new FDA guidelines and public safety. Does anybody know what the new guidelines are?