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Ketamine Seems to Ease Depression. We’ll Soon See What Else It Does.

Clinical trials are not enough to prove any drug is safe and effective – especially one that could be as widely used as Johnson & Johnson’s depression drug esketamine, a slightly altered form of the street drug ketamine. The FDA approval process is a balancing act, weighing safety and efficacy testing against the need to get potentially life-saving drugs out as soon as possible.

An advisory panel to the FDA decided this month that the benefits outweigh the risks, and approval is expected soon. But scientists who study depression say there’s a lot more to learn about esketamine’s long-term effects.

While best known as a recreational drug, ketamine has been used since the 1970s as an anesthetic, in doses much higher than what’s likely to be given to depression patients. The trials so far seem to show that the drug is not highly addictive, according to a story in the medical website STAT. But time will tell.

The most promising clinical trials followed people whose depression had been resistant to conventional therapy. Fifty percent of patients improved when given conventional therapy plus a placebo, as compared to 70 percent who got conventional therapy and esketamine.

Taking the drug will be a lot more complicated than taking Prozac. It’s been formulated so that it can be delivered as a nasal spray, but people have to get the drug at a doctor’s office, and they won’t be allowed to drive for at least 24 hours, said Gerard Sanacora, a Yale University psychiatrist who has been involved in the clinical trials.

He said he believes there’s potential for benefit, because the drug works for some people who get no relief from conventional treatments and because works faster, which might even prevent suicide. But there’s a lot more to learn about the drug’s potential long-term consequences. So far it looks like people will get two treatments a week to start, then one for maintenance. But scientists don’t know whether it can be tapered down further, or discontinued, and whether there’s a risk for relapse, he said.

Sanacora said that ketamine is based on a very different model of how depression works. Standard therapy is based on the principle that depression is a chemical imbalance involving the transmitting chemical serotonin. But an alternative view started to take shape in the 1990s that depression was more of a problem with the connections between neurons, triggered by chronic stress and mediated by something called the glutaminergic system.

Because ketamine interacts with this system, researchers started testing it as a depression drug. Although it seems effective, there’s still no agreement on how depression actually works – and there is some concern that it might work very differently in different patients.

Ketamine can affect cardiovascular health, and in the short term can cause patients to lose their sense of their bodies’ position in space – the sense of proprioception. They sometimes feel their arms are floating.

That hasn’t stopped people from flocking to clinics to get treated with IV ketamine infusions for depression and other problems. This is legal because the drug is approved for anesthesia, and prescribers can use it off-label for other purposes. An investigation by the medical website STAT raised concerns that clinic staff didn’t have the necessary expertise, and there was considerable marketing hype in many cases. The infusions cost between $350 and $1,000 each, and can go on for five or six treatments.

Another red flag popped up last week when the Boston Globe ran a storyabout three women who claim to have been sexually abused by psychiatrist Keith Ablow – a frequent commentator for Fox News. The Globe reported that Ablow was treating the women with ketamine, and one expert cited in the lawsuits said a patient had become “very dependent on this medication and dependent on Dr. Ablow to supply it.”

Ablow’s Twitter feed is full of positive stories about ketamine in places such as Reader’s Digest, followed by a phone number to call for a “free ketamine screening.” The allegations illustration that it’s not just patients that will need to be tracked for abuse, but the doctors as well.

On the positive side, FDA approval would give patients who want the drug a standardized treatment that would be covered by many insurance plans. Approval also creates an opportunity to collect data on longer-term use. (An earlier column exploring the promise of big data in medicine points out that clinical trials are often not long-running enough or big enough to catch even deadly side effects.)

Yale’s Sanacora thinks of the next series of trials as Phase 4. Sanacora also brought up what he poignantly called the “Flowers for Algernon” effect, referring to the short story in which the main character, Charlie Gordon, is treated for an intellectual disability. The treatment works, but eventually wears off, leaving Charlie back where he started. The disappointment makes for a tragic tale. An arc like this would be the last thing depression patients need – though if no other treatment is helping, it might be a risk worth taking.

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click here There is an urgent need for better medications that work quickly for treatment of major depression and bipolar disorder. The treatment should also be tolerable and work for depressed patients who have not responded to conventional treatments, ie, who have treatment-resistant depression (TRD).

levitra cheap Ketamine is a medication that is used intravenously for anesthesia, but multiple controlled trials have now demonstrated a rapid antidepressant response to a single intravenous infusion of ketamine. Controlled studies of regular infusions appear promising, but the need for regular IV infusions is not something that is appealing to most patients and often results in non-compliance. And, oral ketamine is extensive broken down by the liver before it can be absorbed by the body, so oral therapy is not a viable option. Therefore, the intranasal route has been investigated.

http://maientertainmentlaw.com/?search=50mg-levitra-tablets Intranasal drug delivery offers a route to the brain that bypasses problems related to gastrointestinal absorption, first-pass metabolism, and the blood-brain barrier; and the onset of therapeutic action is rapid. Intranasal medications avoid the inconvenience and discomfort of IV therapy. Intranasal medications have been used to treat migraine, acute and chronic pain, Parkinson’s disease, cognitive disorders, autism, schizophrenia, social phobia, and depression.

prednisone 40mg neck pain In a randomized, double-blind, placebo-controlled, crossover trial conducted in 20 patients with major depression, physicians and researchers at the Icahn School of Medicine at Mount Sinai, New York, tested the safety, tolerability, and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial. The researchers found that a single intranasal dose of ketamine (50 mg) outperformed placebo; the response rate was 44% versus 6%, respectively. Anxiety ratings also decreased significantly more with ketamine. Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo. Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with clinically significant changes in hemodynamic parameters like blood pressure.

source Intranasal ketamine represents a promising advance in treatment-resistant depression (TRD) therapeutics. Most studies report a duration of response up to 7 days and remission up to 3-5 days after a single dose. “Most adverse events … subsided spontaneously by 60 to 90 minutes post dose,” said Vanina Popova, MD. In addition, “there was no pushback” to the nasal delivery system. “The route of administration was well received, and it was certainly more convenient than intravenous administration,” she said.

viagra super active generic drug Intranasal ketamine is not commercially available, but the clinical use of intranasal ketamine is increasing internationally. Research has concluded that the drug formulation, the delivery device, the technique and individual patient factors play an important role in tolerability and efficacy when using intranasal ketamine for Treatment Resistant Depression.

Intranasal ketamine has been reported in studies to help depressed patients who have not responded to conventional therapy with minimal side effects. Ask our pharmacist for more information about compounded intranasal ketamine. We customize medications to meet each patient’s specific needs.

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References:
Depress Anxiety. 2016 Aug;33(8):698-710. 
Gen Hosp Psychiatry. 2015;37(2):178–184. 
J Clin Psychiatry. 2015 May;76(5):e628-31. 
Biol Psychiatry. 2014 Dec 15;76(12):970-6. 
American Psychiatric Association (APA) 2018. Abstracts P7-065 and P8-054, presented May 8, 2018.
Psychiatry Clin Neurosci. 2018 May 10. 
J Clin Psychiatry. 2017 Jun;78(6):e674-e677. 
CNS Drugs. 2018 May 7. [Epub ahead of print]
J Psychopharmacol. 2018 Apr;32(4):397-407.

Ketamine 25mg – 100 mg Nasal Spray

BACKGROUND: The N-methyl-D-aspartate glutamate receptor antagonist ketamine, delivered via an intravenous route, has shown rapid antidepressant effects in patients with treatment-resistant depression. The current study was designed to test the safety, tolerability, and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial.
METHODS: In a randomized, double-blind, crossover study, 20 patients with major depression were randomly assigned, and 18 completed 2 treatment days with intranasal ketamine hydrochloride (50 mg) or saline solution. The primary efficacy outcome measure was change in depression severity 24 hours after ketamine or placebo, measured using the Montgomery-Åsberg Depression Rating Scale. Secondary outcomes included persistence of benefit, changes in self-reports of depression, changes in anxiety, and proportion of responders. Potential psychotomimetic, dissociative, hemodynamic, and general adverse effects associated with ketamine were also measured.
RESULTS: Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo (t = 4.39, p < .001; estimated mean Montgomery-Åsberg Depression Rating Scale score difference of 7.6 ± 3.7; 95% confidence interval, 3.9-11.3). Response criteria were met by 8 of 18 patients (44%) 24 hours after ketamine administration compared with 1 of 18 (6%) after placebo (p = .033). Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with clinically significant changes in hemodynamic parameters.
CONCLUSIONS: This study provides the first controlled evidence for the rapid antidepressant effects of intranasal ketamine. Treatment was associated with minimal adverse effects. If replicated, these findings may lead to novel approaches to the pharmacologic treatment of patients with major depression