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FDA approves ketamine for depression

ketamine nootropic antidepressant

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#1 GABAergic

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Posted 06 March 2019 - 12:02 PM


from source; https://www.theverge...-health-science

 

its the intranasal version, not the IV that clinics already practice and its very expensive. so im wondering if this will cut the price and/if intranasal dosing is safer than having IV ketamine in your blood directly.


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#2 justabody

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Posted 08 March 2019 - 04:00 PM

I don't think it will cut price all that much compared to IV infusions; from what I've read health insurance companies aren't gonna be to keen on covering it and each visit to the clinic for the nasal spray (you don't actually administer the medication yourself) is like $900 a pop without coverage. I imagine insurance would lower the price somewhere in the realm of infusions, like $400 - $500. I hope I'm wrong. I don't think any additional safety has been established over infusions, you're still required to drive to a clinic and be supervised for a couple hours before you're released.


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#3 GABAergic

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Posted 08 March 2019 - 08:06 PM

yeah thats a whole bunch of hassle. i thought the idea of IV is just too much and when i found out they approved just simple nasal spray, things will become easier and cheaper but you are right. and to think you still have to drive to a clinic for a nasal spray that takes few seconds? wow. so nobody seems to be trusted having this stuff at their home eh



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#4 YoungSchizo

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Posted 09 March 2019 - 02:09 PM

I'm sorry for you Americans, the insurance there really sucks.

I'm so excited that this drug is also filed in the EU and waits for approval (Ketamine infusions are not, at least not in the Netherlands). Even though I suffer from schizophrenia and it's contraindicated you never know how it'll work out in practice. Maybe I'll finally find relieve from the severe depressive and negative symptom side of schizophrenia.

#5 Mind_Paralysis

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Posted 09 March 2019 - 04:05 PM

I'm sorry for you Americans, the insurance there really sucks.

I'm so excited that this drug is also filed in the EU and waits for approval (Ketamine infusions are not, at least not in the Netherlands). Even though I suffer from schizophrenia and it's contraindicated you never know how it'll work out in practice. Maybe I'll finally find relieve from the severe depressive and negative symptom side of schizophrenia.

 

Dude... for god's sake... PLEASE! Immediately forget any and everything about Ketamine - it can be a useful drug, for some, but NOT for you...!

 

I know you're aware that Ketamine was the "schizo-model" for the experiments that helped create some of the first antipsychotics, yes?

 

 

Honestly, I think it's so dangerous for someone like you, that... no, don't even go near it. Keep far, far away.

 

 

The psychosis it might induce in someone like you, might actually be so dangerous, that it could end up with you, or someone else, DEAD.

 

Yeez dude... you're sending cold sweat and chills down my spine here... please, please, please - don't ever use it... Please?


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#6 GABAergic

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Posted 09 March 2019 - 07:28 PM

repost


Edited by GABAergic, 09 March 2019 - 07:57 PM.


#7 YoungSchizo

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Posted 09 March 2019 - 07:31 PM

Dude... for god's sake... PLEASE! Immediately forget any and everything about Ketamine - it can be a useful drug, for some, but NOT for you...!

I know you're aware that Ketamine was the "schizo-model" for the experiments that helped create some of the first antipsychotics, yes?


Honestly, I think it's so dangerous for someone like you, that... no, don't even go near it. Keep far, far away.


The psychosis it might induce in someone like you, might actually be so dangerous, that it could end up with you, or someone else, DEAD.

Yeez dude... you're sending cold sweat and chills down my spine here... please, please, please - don't ever use it... Please?


Do you by any chance know what the dosages were that were used to create the antipsychotics?

I guess this is a different story because it's basically micro-dosing Esketamine and I'll know from the first dose if it induces psychosis or not, just like with weed. One micro-dose does not and will not cause a full blown psychosis, just maybe an episode like with weed. When it wears of the hallucinations will wear off.

The funny thing is that even it may cause an episode I might still benefit from it's antidepressant effect afterwards.

I'll be very nervous but happy to give Esketamine a shot.

#8 GABAergic

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Posted 09 March 2019 - 07:56 PM

youngschizo, how about you try Yuejo instead; https://www.nature.c...icles/srep13573 its probably it wont cause as severe side effects as ketamine



#9 YoungSchizo

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Posted 09 March 2019 - 08:45 PM

youngschizo, how about you try Yuejo instead; https://www.nature.c...icles/srep13573 its probably it wont cause as severe side effects as ketamine


Interesting, first time I ever heard about Yuejo. What does it costs and where can I get it?

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#10 GABAergic

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Posted 10 March 2019 - 03:53 AM

beats me. im just trying to find alternatives to ketamine since its so expensive and hard to get. not sure i can really find anything substantial i suppose :s



#11 cocoonman

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Posted 11 March 2019 - 05:43 PM

The active constituent in Yueju is Polygala tenuifolia. It is available at Nootropics Depot. A dose of 0.1 mg/kg of Polygala extract in rats produced AD response similar to 10 mg/kg ketamine. Human equivalent dose would be 0.486 mg/day. However, there are no human studies or long-term safety reports, and the herb is expensive to take in the doses required. It may be an option to try when other alternative antidepressants fail. One idea is to augment Polygala with Agmatine, which is known to potentiate NMDA antagonist effect.


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#12 mono

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Posted 12 March 2019 - 04:06 AM

Dude... for god's sake... PLEASE! Immediately forget any and everything about Ketamine - it can be a useful drug, for some, but NOT for you...!

 

I know you're aware that Ketamine was the "schizo-model" for the experiments that helped create some of the first antipsychotics, yes?

 

 

Honestly, I think it's so dangerous for someone like you, that... no, don't even go near it. Keep far, far away.

 

 

The psychosis it might induce in someone like you, might actually be so dangerous, that it could end up with you, or someone else, DEAD.

 

Yeez dude... you're sending cold sweat and chills down my spine here... please, please, please - don't ever use it... Please?

 

I am currently doing ECT under the recommendation of my psychiatrist, and they are using ketamine as an anaesthetic. I do have schizoaffective disorder and so far have not noticed any psychotic symptoms.


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#13 nickthird

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Posted 12 March 2019 - 04:22 PM

Ketamine was used as a sz model because it induces psychotic effects for the first <30 MINUTES of administration. There are no apparent long term psychotic effects.

 

.


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#14 GABAergic

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Posted 12 March 2019 - 04:25 PM

The active constituent in Yueju is Polygala tenuifolia. It is available at Nootropics Depot. A dose of 0.1 mg/kg of Polygala extract in rats produced AD response similar to 10 mg/kg ketamine. Human equivalent dose would be 0.486 mg/day. However, there are no human studies or long-term safety reports, and the herb is expensive to take in the doses required. It may be an option to try when other alternative antidepressants fail. One idea is to augment Polygala with Agmatine, which is known to potentiate NMDA antagonist effect.

 

ive used the polygala from nootropics depot more than once. it helped tremendously with binge drinking. meaning, the moment you feel like drinking another glass, polygala made you stop. not sure the mechanism behind this but its the best remedy for binge drinking that i have found.

of course i must note, i took very high dose which can come up as quite expensive long term. another very interesting thing is by itself polygala didnt do anything for me even in mega doses. not sure why it only worked when alcohol was combined...



#15 GABAergic

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Posted 12 June 2019 - 12:46 AM

anyone started ketamine therapy? now that its legal and prescribed for depression, im curious to hear experiences. is there a possibility i can buy it without prescription somewhere? if someone knows, msg me please, thanks!



#16 YoungSchizo

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Posted 12 June 2019 - 08:57 AM

anyone started ketamine therapy? now that its legal and prescribed for depression, im curious to hear experiences. is there a possibility i can buy it without prescription somewhere? if someone knows, msg me please, thanks!


The Esketamine form that is mentioned in this article/thread is only given in a clinic under supervision of a clinician, and where you have to stay 2 hours for monitoring. There's no way someone can get there hands on it.

Edited by YoungSchizo, 12 June 2019 - 08:58 AM.


#17 Mind_Paralysis

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Posted 12 June 2019 - 12:28 PM

The Esketamine form that is mentioned in this article/thread is only given in a clinic under supervision of a clinician, and where you have to stay 2 hours for monitoring. There's no way someone can get there hands on it.

 

Well, there's always a way... in some of the most corrupt EU-countries, for instance, some samples might slip out to the market. (bulgaria, greece, hungary, romania)

https://www.transparency.org/cpi2018

 

But I do agree that it's probably going to be VERY hard to get prescribed, and possibly only used in a clinical setting.

 

Hmm... I have to have a look if it's approved in any of the Scandinavian countries.


Edited by Mind_Paralysis, 12 June 2019 - 12:56 PM.


#18 YoungSchizo

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Posted 12 June 2019 - 12:41 PM

Well, there's always a way... in some of the most corrupt EU-countries, for instance, some samples might slip out to the market. (bulgaria, greece, hungary, romania)

 

 

But I do agree that it's probably going to be VERY hard to get prescribed, and possibly only used in a clinical setting.

 

Hmm... I have to have a look if it's approved in any of the Scandinavian countries.

 

Probably.. But I think you need deep pockets if it slips illegally to the market.

 

In Europe it's in Pre-registration (Filed) but not approved yet but probably will.. In which way I don't know.. Guess like in the US as a controlled substance.



#19 Mind_Paralysis

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Posted 12 June 2019 - 01:29 PM

Probably.. But I think you need deep pockets if it slips illegally to the market.

 

In Europe it's in Pre-registration (Filed) but not approved yet but probably will.. In which way I don't know.. Guess like in the US as a controlled substance.

 

Btw, you might want to look into the research on the interaction between the serotonin system and ketamine - apparently the 5ht1b receptor may be involved - I'm not sure if it's an agonistic or antagonistic end result though...

 

Regardless, multiple antipsychotics with varying serotonin modulating effects exist - perhaps a combo of an antipsych which agonises 5ht1a, heavily ANTagonises 5ht2a, and some effect on 5ht1b, could ENHANCE the effects of Ketamine, while also keeping you more sane?

 

Worth looking into.

 

 

Ref:

---------

PET studies of the serotonin system in major depression and its treatment

https://openarchive....dle/10616/42184

 

Ketamine-Induced Prefrontal Serotonin Release Is Mediated by Cholinergic Neurons in the Pedunculopontine Tegmental Nucleus

https://www.ncbi.nlm...les/PMC5838842/

 

(might want to use a nicotinic agonist as well - since there appears to be interaction with the cholinergic system - which is also involved in the pathology of Schiz'.)

 

 

A possible mechanism of the nucleus accumbens and ventral pallidum 5-HT1B receptors underlying the antidepressant action of ketamine: a PET study with macaques

https://www.nature.c...icles/tp2013112
 

 

...ketamine administration significantly increased 5-HT1B receptor binding in the nucleus accumbens and ventral pallidum, whereas it significantly reduced SERT binding in these brain regions.

 

...a potent antagonist of the glutamate α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor, blocked the action of ketamine on the 5-HT1B receptor but not SERT binding. This indicates the involvement of AMPA receptor activation in ketamine-induced alterations of 5-HT1B receptor binding.

 

 

Ok - seems like Agonism is the name of the game - because up-regulation = natural agonism.

 

 

Fast-acting antidepressant activity of ketamine: highlights on brain serotonin, glutamate, and GABA neurotransmission in preclinical studies

https://www.scienced...163725819300403


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#20 GABAergic

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Posted 12 June 2019 - 06:43 PM

not sure if you people realize this, but esketamine works the same way as general ketamine the difference is they scewed it a bit so it can pass FDA's rule for new drug because ketamine is already approved as a drug just not for depression so they figured out a way to make profit by having it approved as new novel drug, but its still ketamine after all. so in such case, just look to buy generic ketamine and im sure its much easier to get.



#21 YoungSchizo

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Posted 13 June 2019 - 09:36 AM

not sure if you people realize this, but esketamine works the same way as general ketamine the difference is they scewed it a bit so it can pass FDA's rule for new drug because ketamine is already approved as a drug just not for depression so they figured out a way to make profit by having it approved as new novel drug, but its still ketamine after all. so in such case, just look to buy generic ketamine and im sure its much easier to get.


I don't know about the US but in Europe they're trialing "normal" ketamine as a treatment for depression and afaik the results so far has been positive and probably will also get approval.
Esketamine is just another easier way to administer ketamine by a nasal spray.

Microdosing of streetdrug ketamine however can be tricky..

#22 Daniel Cooper

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Posted 18 June 2019 - 01:48 AM

not sure if you people realize this, but esketamine works the same way as general ketamine the difference is they scewed it a bit so it can pass FDA's rule for new drug because ketamine is already approved as a drug just not for depression so they figured out a way to make profit by having it approved as new novel drug, but its still ketamine after all. so in such case, just look to buy generic ketamine and im sure its much easier to get.

 

That's pretty much "a bingo" as they say.

 

The regular ketamine that's been on the market forever is racemic - it contains both the S(+) and R(-) isomers.  The R(-) isomer is either less biologically active or not active at all, which just means you have to give a larger dose of a racemic mixture.

 

Esketamine is only the S(+) isomer, so it's more potent at an equal dose.  But there's no reason that I'm aware of that the racemic mixture wouldn't work perfectly well and is what is used for IV ketamine treatment for depression.  I suppose there is an argument that having a more potent per unit volume variety is useful for intranasal administration, but that's probably a pretty weak argument.

 

Several US drug companies have pioneered making a single isomer of long time available and therefore off patent exiting drugs as a way to get a new patent.  That's mostly horseshit.  There is a clause in our patent law that says that for an invention to be patentable it "must not be obvious to one skilled in the art".  Now that it's been done at least a dozen time, making a single isomer version of an existing drug is entirely "obvious to one skilled in the art" and should not be allowed, but that clause is as far as I can tell now universally ignored.  I'm sure that has nothing to do with influence by pharmaceutical on politicians.

 

 

 

 

 



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#23 biggyrat

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Posted 28 June 2019 - 06:41 AM

I have been using sublingual Ketamine from a compounding pharmacy, with a script from a psychiatrist.  I cannot say whether it has the same effects as either a IV infusion or the new FDA approved nasal spray.  One time I did have an intra-muscular injection of Ketamine given by a psychiatrist. Was very different of course that the sublingual. The injection was some time ago and if there were any anti-depressant effects from that, they were very very subtle.  I'm not sure that I can say that the sublingual form is an antidepressant exactly either, but it does help me get through.  I've  found one compounding pharmacy where the cost is considerably less than anywhere else that I checked.  I'm in Los Angeles- the psychiatrist that I went to originally for the Ketamine was out of LA about 2 hours.  Currently I have a local MD.  The compounding pharmacy I found is in Colorado.  If anyone wants more specifics,  PM me.  



#24 GABAergic

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Posted 28 June 2019 - 06:40 PM

i want more specifics. please PM me. im curious if insurance of any type covers it.



#25 biggyrat

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Posted 29 June 2019 - 03:18 AM

Hi Gaba, 

 

I'm pretty sure that there is no insurance that will cover what I'm taking.  Its from a compounding pharmacy for one thing.   As far as I know, compounded meds are not covered. However, the pharmacy does send out a super bill to submit if I wanted to.  I don't though. Its costing me about $75 per month for the dosage I'm getting.  


PS- let me know if you still want more info. 



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#26 Keizo

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Posted 13 January 2020 - 01:06 PM

That's pretty much "a bingo" as they say.

 

The regular ketamine that's been on the market forever is racemic - it contains both the S(+) and R(-) isomers.  The R(-) isomer is either less biologically active or not active at all, which just means you have to give a larger dose of a racemic mixture.

 

Esketamine is only the S(+) isomer, so it's more potent at an equal dose.  But there's no reason that I'm aware of that the racemic mixture wouldn't work perfectly well and is what is used for IV ketamine treatment for depression.  I suppose there is an argument that having a more potent per unit volume variety is useful for intranasal administration, but that's probably a pretty weak argument.

 

Several US drug companies have pioneered making a single isomer of long time available and therefore off patent exiting drugs as a way to get a new patent.  That's mostly horseshit.  There is a clause in our patent law that says that for an invention to be patentable it "must not be obvious to one skilled in the art".  Now that it's been done at least a dozen time, making a single isomer version of an existing drug is entirely "obvious to one skilled in the art" and should not be allowed, but that clause is as far as I can tell now universally ignored.  I'm sure that has nothing to do with influence by pharmaceutical on politicians.

If one isomer causes more antidepressant effect but similar toxicity to the bladder per mg, etc, than that might be of interest. I suspect that Ketamine at any dose any human would use has damaging effects to the bladder, but at low enough and infrequent dosages it's most likely not enough to cause anything serious or even notice it. It might be the case that some patients, treated for whatever it is, require much more frequent intake or higher dosages of Ketamine than typically recommended. The thing that would worry me is the bladder issue, and that it seems to relate so much to frequency and high doses, while at the same time Ketamine has mostly been used medically in very infrequent doses. I think Ketamine (or something very similar to it) will become extremely popular as a medication for all kinds of things, so we will see how much side effects are an issue for these new uses/dosages/frequencies. 


Edited by Keizo, 13 January 2020 - 01:16 PM.





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