3 ms·
Some quick points: > 233 patients Very small, can't generalize results based on such a small number. Doesn't mean the study's trash or anything, but don't jum
by MrWiffles 5y ago
Some quick points:
> 233 patients
Very small, can't generalize results based on such a small number. Doesn't mean the study's trash or anything, but don't jump to any conclusions here - good or bad.
> "The trial, which had all patients stopping antidepressants before participating, compared two active doses of COMP360, 25mg and 10mg, against a comparator 1mg dose."
- COMP360 was, I assume, their therapeutic psilocybin but it's unknown if that differs from raw psilocybin or not, and if so in what way.
- Did they TEST and PROVE discontinuation of antidepressants at all stages of the trial? Which kinds of antidepressants did they test for? SSRI? TCA? MAOI? How did they test? Uranalysis? Blood? Or did they just take 233 people's word for it?
> "[...] 179 patients reported at least one adverse event — the most common being headaches, nausea, fatigue and insomnia."
- Likely unrelated to the medication itself, as those can be caused by hundreds (thousands) of factors. Literally included in every possible side effect list for nearly every medication known to exist. Doubtful that the medication caused any of these.
> "There were 12 patients who reported more serious adverse events, such as suicidal behavior, intentional self-injury, and suicidal ideation."
- Do we know how many experienced which specific "serious adverse event"? Was it 11 ideations and 1 behavior that could be interpreted as self-injury, for example?
- Do we know for certain that none of these 12 had any of those adverse events occur in the last few months prior to starting the medication?
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Again, I'm not crapping on this at all here, but folks should take it with a grain of salt and realize there's more to this, that only 12 adverse events isn't a significant concern unless we can show with high confidence that it was caused by the therapy, and at only 5%, even then it sounds like manageable risk as long as a prescriber would know the patient's history before hand.
The announcement - not the study data itself just the press release - is here: https://ir.compasspathways.com/news-releases/news-release-details/compass-pathways-announces-positive-topline-results https://ir.compasspathways.com/news-releases/news-release-de...
- arcticbull 5y ago> Very small, can't generalize results based on such a small number. This comes up pretty often, but how many subjects do you need to know getting punched in the face hurts? It's absolutely possible to get statistically significant data from 233 patients, what matters is how the study is designed.
- deleted 5y ago[deleted]
- tayo42 5y agoYeah For surveying large populations I think you only need around 270 samples to get 90% acuuracy. Something like that, might have mixed up at word it's been awhile since I did stats.
- toomanybeersies 5y ago> Do we know how many experienced which specific "serious adverse event"? From the topline data [1]: - 3 Suicidal behaviour - 5 Self-injury - 4 Suicidal ideation - 1 Drug withdrawal (from codeine?) - 1 Adjustment disorder with anxiety - 1 Adjustment disorder with mixed anxiety and depressed mood - 1 Hospitalisation [1] https://compasspathways.com/knowledge-navigator/pdf/COMP001%20topline%20data%20slides_20211109.pdf https://compasspathways.com/knowledge-navigator/pdf/COMP001%...