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Ketamine Approved For Depression


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#1 KathyInFL

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Posted 06 March 2019 - 10:11 AM

This isn't Cymbalta, but a new drug was just approved for depression. 

 

https://www.mynews13...vere-depression

 

Isn't Ketamine also known as a "Date Rape Drug"?


#2 invalidusername

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Posted 06 March 2019 - 10:32 AM

This is good news! Thanks for sharing Kathy...

 

In much higher doses, Ketamine can be used for all sorts of nasty things, but the dose for depression is very low. There have been a number of tests done with this drug with some amazing success. More than 50% of people with "untreatable" depression saw significant benefits, with a further 35% seeing marginal use. Quite good statistics compared with AD's. 

 

It can be administered intravenously, or by a vapour, and only takes a few minutes. Patients are in and out within the hour. 

 

Despite it not being approved until today, there have been clinics all over the US - and a few in the UK - offering this service for a price, stating off-label. Looks like this cash cow will have ended as it will soon be on prescription.

 

As far as I know, inhalers (developed by Johnson and Johnson) will be given to the patient to self-administer, but there is concern over abuse. In most cases, a dose of the inhaler will only be required every week, or in some cases, every two weeks. So at £150 per treatment, equating to around £500/month on a weekly treatment, this gets expensive. Lets hope that NICE follow suit soon! 


#3 fishinghat

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Posted 06 March 2019 - 10:39 AM

Just so everyone knows but this is not Ketamine.  It is esketamine, an active derivative of Ketamine. It is a nasal spray that takes effect in four hours.

 

Ooops, something came up, will be back shortly with more info.


#4 fishinghat

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Posted 06 March 2019 - 11:05 AM

OK, that is taken care of. Sorry for the interruption.

 

Ketamine has many questionable effects. Its lists of side effects and possible damage to the nervous system is fairly well reviewed on the Wikipedia page. Currently it is approved in the USA as a Class III drug. It is illegal in many states as well.

 

I will look into the esketamine and see what details I can find out.


#5 fishinghat

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Posted 06 March 2019 - 11:31 AM

Esketamine (Spravato)

https://www.ncbi.nlm...pubmed/28759464
We successfully modeled the inhalation of nebulized esketamine in healthy volunteers. Nebulized esketamine is inhaled with a substantial reduction in bioavailability. Although the reduction in dose-independent bioavailability is best explained by retention of drug and particle exhalation, the reduction in dose-dependent bioavailability is probably due to sedation-related loss of drug into the air.

https://www.ncbi.nlm...pubmed/26707087
The most common treatment-emergent adverse events were headache, nausea, and dissociation; the last-mentioned was transient and did not persist beyond 4 hours from the start of the esketamine infusion.
A rapid onset of robust antidepressant effects was observed in patients with TRD after a 40-minute IV infusion of either .20 mg/kg or .40 mg/kg of esketamine. The lower dose may allow for better tolerability while maintaining efficacy.

https://www.ncbi.nlm...pubmed/28790825
Therapeutic response and remission frequencies were seen in 16 (59.3%) and 11 (40.7%) patients, respectively, within 24 hours following drug infusion. The most relevant side effect observed during the esketamine infusion was dissociative symptoms ranging from mild to severe, which was reported by 11.1% of patients as a very disturbing experience.
The present study demonstrates that rapid infusion of esketamine is possibly not the optimal choice to administer this drug for treatment-resistant depression due to tolerability reasons.

https://www.ncbi.nlm...pubmed/29656663
Between-group reductions in clinician global judgment of suicide risk scores were not statistically different at any time point. The most common adverse events among participants in the esketamine group were nausea, dizziness, dissociation, unpleasant taste, and headache.
These preliminary findings indicate that intranasal esketamine compared with placebo, given in addition to comprehensive standard-of-care treatment, may result in significantly rapid improvement in depressive symptoms, including some measures of suicidal ideation, among depressed patients at imminent risk for suicide.

https://www.ncbi.nlm...les/PMC5869899/
Esketamine was associated with cognitive performance decline, and greater effort was required to complete the test battery versus placebo at 40 min postdose, which returned to placebo-comparable levels by 2 h postdose.

https://www.ncbi.nlm...les/PMC5838571/
Three of 56 (5%) esketamine-treated participants during the double-blind phase vs none receiving placebo and 1 of 57 participants (2%) during the open-label phase had adverse events that led to study discontinuation (1 event each of syncope, headache, dissociative syndrome, and ectopic pregnancy).

https://www.fda.gov/...e/UCM631429.pdf
Slide presentation from the Feb. 12 approval meeting.

No drug insert is available at this time.
 


#6 fishinghat

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Posted 06 March 2019 - 11:37 AM

and this..

https://www.forbes.c...n/#71fa966e3e03

As much as people with treatment-related depression need better options, the clinical trials on esketamine have not been uniformly positive. In a memo to the FDA advisory committee that voted to approve esketamine 14-2 with one abstaining on February 12, Tiffany R. Farchione, acting director of the FDA’s Division of Psychiatry Products, noted that the phase-3 clinical trial evidence supporting approval of esketamine came from one short-term study with a flexible dose and a randomized withdrawal study, when most approved antidepressants have at least two positive short-term trials. Another short-term study with designated doses did not demonstrate that esketamine helped patients more than a placebo.


#7 invalidusername

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Posted 06 March 2019 - 11:48 AM

Very strange that there have been such a mixture of effects. This really does need looking into more. How can one study show 50% over placebo, whilst another shows no difference? There MUST be some factors in there which are contributing to these results. No question. 

 

The side effects of the vapour do sound concerning, but for those with TRD, four hours per week to suffer these is a drop in the ocean. It will be interesting to see if such effects get easier as treatment progresses. 

 

Also, big absence of long-term studies - but that would be normal for new drugs of course.


#8 fishinghat

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Posted 06 March 2019 - 12:37 PM

"It will be interesting to see if such effects get easier as treatment progresses."

This is a key factor I picked up on. It seems that the studies of less than 2 weeks were minimally effective at best but those who took it for 2 to 6 weeks showed more significant improvements. Yes, I thin k you are right. Those who think this will be a short term fix when depression flairs up may be disappointed but for long term use it may be an asset.

#9 invalidusername

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Posted 06 March 2019 - 03:21 PM

Now that it has approval, we should see a lot more studies coming out. I anticipate there more issues - despite it being labeled a wonder drug, and the cure-all for depression. Let's not forget that Prozac started out life with a similar reputation, and here we are 30 years on, still looking for the miracle...





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