Here is the Data Sharing Statement, in its entirety, for Goodwin GM, Aaronson ST, Alvarez O, et al. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. DOI: 10.1056/NEJMoa2206443.
8 thoughts on “Here is the Data Sharing Statement, in its entirety, for Goodwin GM, Aaronson ST, Alvarez O, et al. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. DOI: 10.1056/NEJMoa2206443.”
The administration session (day 1) lasted 6 to 8 hours, with the lead therapist who had pre-pared the participant for the intervention and an assisting therapist in attendance. A trial psychia-trist was available on site for consultation. Ad-ministration rooms were designed to provide a nonclinical, calming atmosphere. During the administration session, participants listened to a specially designed music playlist while wearing eyeshades to help direct attention internally. After at least 6 hours and when the psychedelic effects of the drug had fully dissipated, partici-pants returned home.
3) Does not generalize to other conditions- Like painkillers that are not addictive when an authority figure gives it to you in the hospital, which is totally different than taking them at home while you watch tv.
One (unrealistically) charitable perspective is that there can sometimes be a gap between that document and actual data availability — potentially in the direction of the data being more available than that would make it seem.
For example, in your paper (Zwet et al., 2023, NEJM Evidence) the data sharing statement, in that same form, still just says, in response to “Will the data collected for your study be made available to others?”, “Not a clinical trial”
(https://evidence.nejm.org/doi/suppl/10.1056/EVIDoa2300003/suppl_file/evidoa2300003_data-sharing.pdf). But then actually the data, if not the analysis code, is available!
So one could hope something like that could be true here.
At least they’re honest. And brief too!
The other pattern here is that both these are for trials of things that aren’t doing well.
(I started to enumerate the problems with these two classes of drugs, but you all already know them, I’d guess.)
A short and succinct answer to the question “should you trust the results of this study?”
https://pubmed.ncbi.nlm.nih.gov/36322843/
This sounds like a horrible thing to do to someone. They should be in the woods or flying a kite on the beach or something.
This is a good example of why whole RCT approach just doesn’t work though.
1) Blinding failed- the subjects and therapists could tell how strong the effect was
2) Dose needs to be tailored to the individual, its crazy to give everyone the same
This approach couldn’t even figure out that water puts out housefires. Or filling tires with air fixes flat tires.
Sorry:
3) Does not generalize to other conditions- Like painkillers that are not addictive when an authority figure gives it to you in the hospital, which is totally different than taking them at home while you watch tv.
This is the same feeling I get when I grade students’ assignments and they speed through complex and important sections with causal remarks.
I have no way of verifying this is legit, but there’s a public playlist on Spotify called “Psilocybin clinical trial playlist v2.0.”
I’m going to leave off the http header in the hope of evading the spam filter:
open.spotify.com/playlist/7Ab1gzQkoCb3Wg5feQBu55?si=f17d77c161e143fc
One (unrealistically) charitable perspective is that there can sometimes be a gap between that document and actual data availability — potentially in the direction of the data being more available than that would make it seem.
For example, in your paper (Zwet et al., 2023, NEJM Evidence) the data sharing statement, in that same form, still just says, in response to “Will the data collected for your study be made available to others?”, “Not a clinical trial”
(https://evidence.nejm.org/doi/suppl/10.1056/EVIDoa2300003/suppl_file/evidoa2300003_data-sharing.pdf). But then actually the data, if not the analysis code, is available!
So one could hope something like that could be true here.