Sage 217 clinical trials started

Just in case people have not picked up on it.

If you’re locating in the U.S., here’s the website where you can potentially qualify for the phase 3 sage-217 trial:

https://landscapedepressionstudies.com/

Hoping to hear some feedback of members who qualify (I’m unfortunately from Canada!).

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Replacement of Allopregnanolone with a synthetic hormone may lead to a suppression of the natural hormone. The body will detect the synthetic version then may decide after a period of 14 days that there is enough of the hormone within the body and thus stops natural production. Therefore cycling the drug for 14 days then coming off maybe a way to minimize the risk of damaging natural production assuming what I write is correct. So this drug may only provide a short term solution via cycling but still it should improve the patients quality of life during treatment.

With anabolic steriods a 6 month shut down of natural production is enough to damage the HPTA and result in lower levels of natural testosterone being produced on a permanent basis. The longer our natural production is shut down the greater the risk to natural secretion within the body. There is no guarantee that the body will accept a synthetic version over a long period of time. TRT patients have sometimes found testosterone treatments have started to fail after many years of use and require a long period off the medication.

We also don’t know how PFS will react if Allopregnanolone is introduced to the body at normal levels or what will happen to PFS if we come off synthetic Allopregnanolone. Then there will be a period of low natural production as the body restarts secretion.

The hormone system is a carefully balanced orchestra :slight_smile: we don’t know what affect a synthetic version will have on other hormones or functions of the body. An example would be how synthetic testosterone can thicken the blood and increase risk of a clot formation. An Endocrinologist would probably have a better idea as to the suitability of this medication over a long period and the potential side affects to natural production. If anyone here is visiting an Endo it might be worth asking during the consultation what their Drs thoughts are on synthetic Allopregnanolone.

lol I’ve been to three of the supposedly “highest rated” endocrinologists in my metropolitan area and they all told me there isn’t even a blood test for DHT ffs. Would love to hear their thoughts on synthetic Allopregnanolone…

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It’s almost funny that “high rated” endos wouldn’t even be bothered to look it up.

As far as an exogenous allopregnenolone analogue shutting down natural production, I’ve never heard of a feedback mechanism involving allopregnenolone, but haven’t been bothered to look into it. It would be a shame if this works but leads to dependency. Still better than if it doesn’t work.

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source?

Thanks Dubya. It’s worth raising these concerns, if we fail to prepare were prepared to fail :slight_smile: trusting a pharmaceutical company is what brought us here in the first place. A treatment that leads to dependency would be a shame like you said. Lets see if someone can clear this up on their next visit to an Endo.

It is doubtful any endocrinologist, outside of neurosteroid specialists, could answer this. If they would even have an answer. Feedback mechanisms of allo may have never been investigated.

There is some back-coversion of allopregnanolone to DHP, which acts on progesterone receptors. But sage-217 is only similar to allopregnanolone, so it may not undergo a similar conversion to a DHP equivalent, or the metabolite may be inactive.

Someone else said that perhaps the drug is proposed to be administered in cycles because of a potential for tolerance or shutdown.

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i thought it was proposed for long cycles because it was designed as an “anti biotic” that keeps the symptoms away for a long time

thats what i read on the sage websites and papers

In addition to Sage, there seems to be another possible treatment for the depressive sides, which hopefully won’t have more compounding sides of its own:

The active ingredients of ketamine, a popular club drug, show promise in battling deep despair.

will they reach their goal to finish SAGE217 trails by end of this year?

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Just an update:

“Jonas wrote the first-ever book about Prozac, called, “Everything you need to know about Prozac,” partly in reaction to a colleague’s negative article about the drug”

https://www.bizjournals.com/boston/blog/bioflash/2015/06/five-things-you-don-t-know-about-jeff-jonas-ceo.html

How much can we trust a guy who feels positive about Prozac? (Feel free to correct me. I haven’t read his book on Prozac)

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Also the price of the drug is insane.

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I’m moving to Salt Lake City from Australia soon, but it seems the closest trial would be LA. Does anyone know if you need to be a US citizen to apply?

Sage 217 (Zuranolone) should be cheaper than Zulresso (Brexanolone), not sure by how much.

This is probably up to the individual center or researcher conducting the trial. I wouldn’t imagine it would be a huge problem so long as you have a visa that is valid for the duration of the trial.

Myself and a friend applied for the last round of Zuranolone trials (I was rejected for some reason and she wouldn’t commit to the travel burden required at the risk of being given placebo).

There isn’t much work involved in applying. You could complete the online forms and see what happens

Thanks - there’s actually a trial in Vegas which isn’t too far, but I’ll apply and see.

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Anyone update on Sage ?

Are they still trying to bring their allopregnanolone drug to the market ?

Zuranolone officially FDA approved.

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Any word yet on how much Zuranolone will cost patients ?