[HN Gopher] MDMA-assisted therapy for PTSD: A randomized, placeb...
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       MDMA-assisted therapy for PTSD: A randomized, placebo-controlled
       phase 3 trial
        
       Author : beefman
       Score  : 34 points
       Date   : 2023-09-15 21:42 UTC (1 hours ago)
        
 (HTM) web link (www.nature.com)
 (TXT) w3m dump (www.nature.com)
        
       | notamy wrote:
       | > There were no deaths or serious TEAEs [treatment emergent
       | adverse event]. These data suggest that MDMA-AT reduced PTSD
       | symptoms and functional impairment in a diverse population with
       | moderate to severe PTSD and was generally well tolerated.
        
         | prashp wrote:
         | But also
         | 
         | > Seven participants had a severe treatment emergent adverse
         | event (TEAE) (MDMA-AT, n = 5 (9.4%); placebo with therapy, n =
         | 2 (3.9%)).
        
       | [deleted]
        
       | RadixDLT wrote:
       | dupe: https://news.ycombinator.com/item?id=37524353
        
         | dang wrote:
         | Thanks! but on HN, we don't count reposts as dupes if the story
         | hasn't had significant attention yet. This is to give good
         | stories multiple changes at getting attention.
         | 
         | This is in the FAQ (https://news.ycombinator.com/newsfaq.html)
         | and there are past explanations at
         | https://hn.algolia.com/?dateRange=all&page=0&prefix=true&que...
         | if interested.
        
       | mountainriver wrote:
       | Overall seems positive, some interesting pieces:
       | 
       | > The only measured exploratory covariate with a significant
       | interaction with treatment was lifetime history of SSRI use,
       | which was associated with improved efficacy of MDMA-AT (P = 0.02;
       | Supplementary Table 5). Covariates significantly impacting the
       | main effect were sex assigned at birth and baseline Beck
       | Depression Inventory (BDI)-II score; female sex assigned at birth
       | and baseline BDI-II score >=23 were both associated with improved
       | outcomes irrespective of treatment assignment (P < 0.05).
       | 
       | This is an interesting outcome, particularly the SSRI usage
       | 
       | > Eight participants (MDMA-AT, n = 7; placebo with therapy, n =
       | 1) experienced cardiac TEAEs, which included palpitations (MDMA-
       | AT, n = 5 (9.4%); placebo with therapy, n = 1 (2.0%)) and
       | tachycardia (MDMA-AT, n = 2 (3.8%)); all were mild.
       | 
       | Seems a bit concerning, but I have little to measure this
       | against.
       | 
       | > superiority of MDMA-AT over SSRIs cannot be assumed without a
       | direct comparison
       | 
       | I feel as though this should be done. Even though the results are
       | promising they come with a significant safety risk for the
       | participants who are essentially at the mercy of the
       | administrator and could be easily subject to abuse.
       | 
       | That being said, for people with severe PTSD this is surely a
       | godsend. Maybe we can mitigate the safety issue other ways.
        
       | singingfish wrote:
       | I've been hearing about this for a long time - probably since the
       | late 1990s, so I'm surprised to see that it seems only in the
       | last couple of years that there are phase three trials. I would
       | imagine that the safety profile of MDMA is already well
       | understood / fairly well researched in the 1950s and 1960s
        
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       (page generated 2023-09-15 23:00 UTC)