Sage Therapeutics Clinical trial of SAGE-217 (Zuranolone)

Personally I’m not that big into conspiracies

I wonder what data they have on the relationship between all levels and depressive symptoms. Surely they developed this drug based upon such research rather than simply the postpartum case of low allow levels which has been long established…

All you have to do is google scholar search allo and depression to see what the literature is. In the meantime, if you are depressed, I would recommend doing 23andMe if there is nothing else you can do. The best antidote to helplessness is just doing things that advance yourself. Ultimately, the only way we are going to get out of this mess is by making research happen. If we do not do that, then the next ten years will be the same as the last.

I just read that sage will likely try to go for treatment resistant depression rather than major.

I think we would have treatment resistant?

Treatment resistant depression is just what you call depression that hasn’t gone away after attempted treatment with all the standard treatments such as SSRIs and psychotherapy. So I guess rather than doing the study on anyone with major depression, they will be doing the trial on people who have depression and have tried many treatments without success. But has that trial already started or will it be at square one, which would involve a lot of time designing the trial, applying for it, getting it funded, recruiting subjects, etc?

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Anyway, this was never going to be the cure. It was always only possibly a bandaid for one aspect of PFS that has only been shown in one study.

apparently there were 3 trials going on and this one that failed was just 1 of the 3.

so im guessing its going on? if someone knows better please correct me

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true but people like me who are dealing with mostly/only cognitive and mental symptoms would benefit largely. even with people who deal with both sexual and mental would be able to cope and tolerate way better. a healthy brain goes a long way

a guy who boosted his allo with an SSRI (which i dont plan on touching) said his emotional range came back and his brain fog is cured.

i have brain fog, insomnia, and emotional blunting. allopregnanolone would be godly to me and many others.

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This statement is misleading - there is no way to know for sure:
a) That his allo levels were boosted
b) That there wasn’t another mechanism at play which helped his mental symptoms, such as an increase in available serotonin, etc

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there is another guy that took baclofen and reported the same benefits minus the brain fog reduction (because it hits Gaba B instead of A maybe).

either way, i am very much inclined to believe that

a) allo was boosted
b) the allo mechanism was in play

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“Attention will now turn to three other studies of SAGE-217 in depression and insomnia that Sage has already initiated. Changes to the SAGE-217 pivotal program are possible, with Jonas stating that “drug development is an iterative process.””

so good news is the other studies are already going on, and there’s 3 of them.

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I wish Sage would do a trial for PFS patients.

As far as the medical community is concerned, PFS does not exist. Until we get several studies published in high prestige journals, PFS does not exist. That’s why the only thing that really matters right now is that we do everything in our power to promote more studies. No drug company or research agency or anyone will commit efforts toward therapy for something that doesn’t exist. It is up to us to bootstrap our selves into being recognized as existing, via research.

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How can they totally disregard the medical studies done by Robert Melcangi?

They will probably try and say that the Melcangi studies were too small to have any significance.

If you look at any medical hypothesis in the literature, there will generally be multiple studies/investigations of it with varied results. Ultimately, to be taken seriously, the confirming results need to overwhelm the negative results. So there need to be a lot of studies of our problem. Right now there are only a handful and perhaps the most prestigious one (Harvard) says PFS doesn’t exist. I’m not in medicine and don’t want to misrepresent my specific knowledge of the current literature in this field. Just saying that looking at it as a whole it doesn’t come close to meeting the bar to be taken seriously according to traditional scientific standards. One little study like Melcangi’s doesn’t have a lot of sway. Its value would probably mostly just be in stimulating more interest from other scientists. But it hasn’t happened yet and presumably never will until there is more. We need to get snowball rolling. It’s the only way out of this mess and the clock is ticking on us. If we don’t do it ourselves, then we get sacrificed one by one until some generation later finally sees the light and says “we are going to die lives screwed up like those that came before us unless we get serious and do the research”

Once there a nice chunk of literature, scientists can go to agencies like NIH and say “There are X people showing Y severe symptoms that are causing great suffering them and their families. Bio markers a,b,c lend credibility to the notion this may be addressable. Please look at my research plan wherein I will achieve deliverable Z. This plan will cost X amount to execute. Please give it to me.”

If the case is strong, assessed by the quality of literature that supports it, then scientists will get money and the snowball gets big. Eventually one of the deliverables is patients recovering.

This is how we will get a cure, not bumbling around the internet trying random drugs and supplements that not only have always failed for over decade now but furthermore have made a lot of people worse off.

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Yes we all understand that.

I’m not sure why you think there aren’t legitimate efforts put towards getting those studies started

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I see people being depressed that this allo drug isn’t coming out yet most haven’t even done the 23andMe test, for example. I just generally think if more people knew how the treatment discovery process worked then they would spend less time being cynical with victim mentality and more time doing things that advance us.

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There are very real reasons why people haven’t done the 23andMe test, but rightfully hold out hope for Sage providing them some level of symptomatic relief.

  1. The test is expensive for those not in the US. We’re talking about $200+ if you’re in Australia, for instance.
  2. The likelihood of discovering anything meaningful from the very limited coverage of the genome is very low.

I’m not saying that we shouldn’t all be doing it, but simply spelling out the reasons why people may not all be piling on to get it done.