{"id":67548,"date":"2016-08-18T18:25:16","date_gmt":"2016-08-18T22:25:16","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=67548"},"modified":"2016-08-24T20:14:53","modified_gmt":"2016-08-25T00:14:53","slug":"the-best-predictor-5","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/08\/18\/the-best-predictor-5\/","title":{"rendered":"the best predictor&#8230;"},"content":{"rendered":"\n<div align=\"justify\" class=\"small\">I don&#8217;t know anything about <font color=\"#200020\">Ketamine<\/font> except what I read. It is an FDA Approved off-patent anesthetic by day, and a club drug by night [<em><font color=\"#200020\">Special K<\/font><\/em>]. We began to hear about it as an antidepressant around the time that it became apparent that PHARMA was abandoning CNS drug development in 2012. It&#8217;s given iv and is a lightweight hallucinogen. The excitement was that the <font color=\"#200020\">antidepressant effects<\/font> seemed to persist for a variable period of time [<font color=\"#200020\">days<\/font>] after the <em><font color=\"#200020\">druggie<\/font><\/em> effects wore off [<font color=\"#200020\">hours<\/font>]. And in a modern world, there was another problem &#8211; it&#8217;s generic &#8211; ergo no blockbuster potential in sight [or so I thought]. But then the cynical part of my mind got engaged when I saw commentaries by major KOLs&nbsp; <em><font color=\"#200020\">suggesting caution[???]<\/font><\/em> [full text on-line]:<\/div>\n<ul><sup>        <\/p>\n<li><a href=\"http:\/\/ajp.psychiatryonline.org\/doi\/full\/10.1176\/appi.ajp.2014.13101434\" target=\"_blank\">A word to the wise about ketamine<\/a><br \/>      by <strong><font color=\"#660033\">Alan Schatzberg<\/font><\/strong><br \/>      <strong><font color=\"#004400\"> AJP<\/font><\/strong> 2014 171:<span class=\"articlePageRange\">262-264.<br \/>      March 2014.<\/span><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/psychnews.psychiatryonline.org\/doi\/full\/10.1176%2Fappi.pn.2015.2a26\">The ketamine challenge: when practice leaps ahead of science<\/a><br \/>      by <strong><font color=\"#660033\">Jeffrey Lieberman<\/font><\/strong><br \/>      <strong><font color=\"#000001\">Psychiatric<\/font><font color=\"#990000\">News<\/font><\/strong><br \/>      February 3, 2015.<\/li>\n<li><a href=\"https:\/\/www.researchgate.net\/publication\/282435255_Ketamine_and_Other_NMDA_Antagonists_Early_Clinical_Trials_and_Possible_Mechanisms_in_Depression\" target=\"_blank\">Ketamine and Other NMDA Antagonists<\/a>:<br \/>     <a href=\"https:\/\/www.researchgate.net\/publication\/282435255_Ketamine_and_Other_NMDA_Antagonists_Early_Clinical_Trials_and_Possible_Mechanisms_in_Depression\" target=\"_blank\">Early Clinical Trials and Possible Mechanisms in Depression<\/a><br \/>     by Jeffrey Newport, Linda Carpenter, William McDonald, James Potash, Mauricio Tohen, <strong><font color=\"#660033\">Charles Nemeroff<\/font><\/strong>, and The APA Council of Research Task Force on Novel Biomarkers and Treatments<br \/>    <strong><font color=\"#004400\">AJP<\/font><\/strong> 2015 172:950-966.<br \/>    October 2015.<\/li>\n<p>     <\/sup><\/ul>\n<div align=\"justify\" class=\"small\">These are <u>not<\/u> the kind of people who <em><font color=\"#200020\">suggest caution[???] <\/font><\/em>about drugs, and I freely admit that I was immediately suspicious that they were holding out for something PHARMA could market and downplaying Ketamine itself [call me paranoid? or call me wise?]. That last Nemeroff paper was a review article and I wrote about it in <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2015\/10\/07\/a-touch-of-paralysis\/\">a touch of paralysis&hellip;<\/a>. I did think they were talking up <font color=\"#200020\">Rapastinel<\/font>, a patented Ketamine analog and that the evidence base for that drug was beyond shaky [see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2015\/10\/24\/infomercials\/\">infomercials&hellip;<\/a> and <a href=\"http:\/\/1boringoldman.com\/index.php\/2016\/03\/10\/shame-on-us\/\"><em>shame on us<\/em>&hellip;<\/a>]. Then shortly after the Nemeroff article was published, another contender came on the scene from <strong><font color=\"#990000\">Johnson and Johnson<\/font><\/strong> &#8211; <font color=\"#200020\">Esketamine<\/font>. <font color=\"#200020\">Esketamine <\/font>and <font color=\"#200020\">Ketamine<\/font> are <a href=\"https:\/\/en.wikipedia.org\/wiki\/Enantiomer\" title=\"Enantiomer\">enantiomers<\/a> &#8211; moleculers that have the same chemical formula but are mirror images that can&#8217;t be superimposed on each other. There is some evidence that their properties as drugs differ, summarized <a target=\"_blank\" href=\"https:\/\/en.wikipedia.org\/wiki\/Esketamine#Pharmacology\">here<\/a>. In November 2015, <strong><font color=\"#990000\">Johnson and Johnson<\/font><\/strong>  received a <font color=\"#200020\">Breakthrough Therapy Designation<\/font> for&nbsp; treatment resistant depression based on this report of a phase 2 clinical trial:<\/div>\n<blockquote>\n<div align=\"center\" class=\"middle\"><a target=\"_blank\" href=\"http:\/\/www.biologicalpsychiatryjournal.com\/article\/S0006-3223%2815%2900914-2\/fulltext\">Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study<\/a><\/div>\n<div align=\"center\" class=\"middle\">by Jaskaran B. Singh , Maggie Fedgchin, Ella Daly, Liwen Xi, Caroline Melman, Geert De Bruecker, Andre Tadic, Pascal Sienaert, Frank Wiegand, Husseini Manji, Wayne C. Drevets, and Luc Van Nueten<\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#cc6600\">Biological Psychiatry.<\/font><\/strong> November 3, 2015. EPub ahead of print.<\/div>\n<div align=\"center\" class=\"middle\">[<a target=\"_blank\" href=\"http:\/\/www.biologicalpsychiatryjournal.com\/article\/S0006-3223%2815%2900914-2\/fulltext\">full text online<\/a>]<\/div>\n<div align=\"center\" class=\"middle\">[<a target=\"_blank\" href=\"http:\/\/www.biologicalpsychiatryjournal.com\/cms\/attachment\/2062742993\/2065297803\/mmc1.pdf\">supplemental information<\/a>]<\/div>\n<p>   <\/p>\n<div align=\"justify\"><strong><font color=\"#200020\">BACKGROUND:<\/font><\/strong>  The purpose of this study was to assess the efficacy and safety and to explore the dose response of esketamine intravenous [IV] infusion in patients with treatment-resistant depression [TRD].<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">METHODS:<\/font><\/strong>  This multicenter, randomized, placebo-controlled trial was conducted in 30 patients with TRD. Patients were randomly assigned 1:1:1 to receive an IV infusion of .20 mg\/kg or .40 mg\/kg esketamine or placebo over 40 minutes on day 1. The primary end point was change in Montgomery-&Aring;sberg Depression Rating Scale total score from day 1 [baseline] to day 2. Nonresponders who received placebo on day 1 were randomly assigned again 1:1 to IV esketamine .20 mg\/kg or .40 mg\/kg on day 4. Secondary efficacy and safety measures were also evaluated.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">RESULTS:<\/font><\/strong>  Of the enrolled patients, 97% [29 of 30] completed the study. The least squares mean changes [SE] from baseline to day 2 in Montgomery-&Aring;sberg Depression Rating Scale total score for the esketamine .20 mg\/kg and .40 mg\/kg dose groups were -16.8 [3.00] and -16.9 [2.61], respectively, and showed significant improvement [one-sided p = .001 for both groups] compared with placebo [-3.8 [2.97]]. Esketamine showed a rapid [within 2 hours] and robust antidepressant effect. Treatment-emergent adverse events were dose dependent. 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.<\/div>\n<div align=\"justify\"><strong><font color=\"#200020\">CONCLUSIONS:<\/font><\/strong>  A rapid onset of robust antidepressant effects was observed in patients with TRD after a 40-min IV infusion of either .20 mg\/kg or .40 mg\/kg of esketamine. The lower dose may allow for better tolerability while maintaining efficacy<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">But that was just for starters. They&#8217;ve been working on an intranasal delivery version for seven years, recently presented [reference: Canuso C, et al. &quot;<font color=\"#200020\">Esketamine for  the Rapid Reduction of the Symptoms of  Major Depressive Disorder,  Including Suicidal Ideation, in Subjects  Assessed to be at Imminent  Risk for Suicide.<\/font>&quot; Society of Biological  Psychiatry 71<sup>st<\/sup> Annual Scientific Meeting. <span class=\"xn-chron\">May 12-14, 2016<\/span>.]. Now <strong><font color=\"#990000\">Johnson and Johnson<\/font><\/strong> has just been granted <font color=\"#200020\">Breakthrough Therapy Designation<\/font> for the <em><font color=\"#200020\">intranasal<\/font><\/em> version for both treatment resistant depression and major depressive  disorder with imminent risk for suicide [<font color=\"#200020\">Breakthrough Therapy Designation<\/font> is essentially a fast-track FDA Approval process for promising and much-needed drugs].   <\/div>\n<blockquote>\n<div align=\"center\" class=\"middle\"><a href=\"http:\/\/www.jnj.com\/news\/all\/Esketamine-Receives-Breakthrough-Therapy-Designation-from-US-Food-and-Drug-Administration-for-Major-Depressive-Disorder-with-Imminent-Risk-for-Suicide\" target=\"_blank\">Esketamine Receives Breakthrough Therapy Designation from U.S.  Food and Drug Administration for Major Depressive Disorder with  Imminent Risk for Suicide<\/a><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#990000\">Johnson and Johnson<\/font><font color=\"#200020\">: Press Release<\/font><\/strong><\/div>\n<div align=\"center\">August 16, 2016<\/div>\n<p align=\"justify\">Janssen Research &amp; Development, LLC, one of  the Janssen Pharmaceutical Companies of Johnson &amp; Johnson, announced  today that the U.S. Food and Drug Administration [FDA] has granted a  Breakthrough Therapy Designation for &nbsp;esketamine, an investigational  antidepressant medication, for the indication of major depressive  disorder with imminent risk for suicide. If approved by the FDA,  esketamine would be one of the first new approaches to treat major  depressive disorder available to patients in the last 50 years.<\/p>\n<p align=\"justify\">This  also marks the second time esketamine has received a Breakthrough  Therapy Designation from the U.S. regulatory authority. Esketamine was  first granted this designation for treatment-resistant depression in  November 2013. Breakthrough Therapy Designation is intended to expedite  development and review timelines when preliminary clinical evidence  indicates the drug may demonstrate substantial improvement on one or  more clinically significant endpoints over available therapies for  serious or life-threatening conditions.<\/p>\n<p align=\"justify\">The esketamine Phase 2 clinical trial data presented by Janssen in May 2016 at the Society of Biological Psychiatry 71<sup>st<\/sup>  Annual Scientific Meeting in Atlanta, Georgia, provided preliminary  clinical evidence to support the Breakthrough Therapy Designation for  major depressive disorder with imminent risk for suicide.          <\/p>\n<div><strong><font color=\"#200020\">About Esketamine<\/font><\/strong>          <\/p>\n<div align=\"justify\">  Esketamine  for intranasal administration is an investigational compound being  studied by Janssen as part of a global development program. Esketamine  is a non-competitive and subtype non-selective activity-dependent  N-methyl-D-aspartate [NMDA] receptor antagonist, which has a novel  mechanism of action, meaning it works differently than currently  available therapies for depression. The program in treatment-resistant  depression is currently in Phase 3, with six ongoing clinical trials&#8230;<\/div>\n<div align=\"right\">[see also <a href=\"http:\/\/www.cnn.com\/2016\/08\/17\/health\/ketamine-depression-treatment\/index.html\" target=\"_blank\">Party drug ketamine closer to approval for depression<\/a> &#8211; CNN] <\/div>\n<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\"><img decoding=\"async\" vspace=\"6\" hspace=\"4\" height=\"150\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/special-k.gif\" \/><img decoding=\"async\" vspace=\"3\" hspace=\"4\" height=\"85\" border=\"1\" align=\"left\" src=\"http:\/\/1boringoldman.com\/images\/gorsky.jpg\" alt=\"Alex Gorsky\" title=\"Alex Gorsky\" \/>I&#8217;ll have to admit that the notion of seeing a suicidal patient and offering them a sniff of some version of <strong><font color=\"#990000\">Special K<\/font><\/strong> as a treatment strikes me as borderline ludicrous, hard for me to say with a straight face &#8211; but stranger things have happened. That&#8217;s not why I&#8217;m writing about it. Remember, this is <strong><font color=\"#990000\">Johnson and Johnson<\/font><\/strong>, the people who gave us <font color=\"#200020\">TMAP<\/font> and all of the <font color=\"#200020\">Risperidal&reg;<\/font> sheenanigans. The CEO is still Alex Gorsky &#8211; West Point graduate and lifelong Boy Scout, who brought in Billions with all kinds of hanky-panky, flooding the literature with articles churned out by <font color=\"#200020\">Excerpta Medica<\/font>. <strong><font color=\"#990000\">Johnson and Johnson<\/font><\/strong> gladly paid the <font color=\"#200020\">cost-of-doing-business<\/font> fines of around $2.2 B &#8211; trivial in the face of their ill-gotten gains.&nbsp; And with <font color=\"#200020\">Risperidal&reg;<\/font>, they were also first-on-the-market:  <\/div>\n<p align=\"center\" class=\"small\"><img decoding=\"async\" width=\"520\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/risperdal-total-1.gif\" \/><\/p>\n<p align=\"justify\" class=\"small\">Here&#8217;s a roster of their <font color=\"#200020\">Esketamine<\/font> clinical trials from <a target=\"_blank\" href=\"https:\/\/clinicaltrials.gov\/ct2\/results?term=esketamine&#038;Search=Search\">clinicaltrials.gov.<\/a> As you can see, they&#8217;re going long on Esketamine. It&#8217;s a hungry market and they&#8217;re going after it. And then there&#8217;s that old saying, &quot;<font color=\"#200020\">The best predictor of future behavior is past behavior.<\/font>&quot;  <\/p>\n<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" align=\"center\">\n<tr>\n<td valign=\"top\" align=\"center\" class=\"small\"><strong><font color=\"#200020\">NCT #<br \/>             &nbsp; <\/font><\/strong><\/td>\n<td width=\"5\" align=\"center\" rowspan=\"29\">&nbsp;<\/td>\n<td valign=\"top\" align=\"center\" class=\"small\"><strong><font color=\"#200020\">Title<\/font><\/strong><\/td>\n<td width=\"5\" align=\"center\" rowspan=\"29\">&nbsp;<\/td>\n<td valign=\"top\" align=\"center\" class=\"small\"><strong><font color=\"#200020\">Status<\/font><\/strong><\/td>\n<td valign=\"top\" align=\"center\" class=\"small\"><strong><font color=\"#200020\">Phase<\/font><\/strong><\/td>\n<td valign=\"top\" align=\"center\" class=\"small\"><strong><font color=\"#200020\">Start<\/font><\/strong><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT01394757\">NCT01394757<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging [phMRI]<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>&#8211;<\/sup><\/td>\n<td valign=\"top\"><sup>08\/2011<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT00847418\">NCT00847418<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>02\/2009<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT01780259\">NCT01780259<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>12\/2012<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02060929\">NCT02060929<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>10\/2013<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT01980303\">NCT01980303<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Assess the Pharmacokinetics of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Volunteers<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>11\/2013<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02129088\">NCT02129088<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Pharmacokinetic, Safety and Tolerability Study of Esketamine in Healthy Elderly and Adult Participants<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>03\/2014<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02094378\">NCT02094378<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>06\/2014<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02154334\">NCT02154334<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>06\/2014<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02228239\">NCT02228239<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>09\/2014<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02345148\">NCT02345148<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>12\/2014<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02343289\">NCT02343289<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Evaluate the Absolute Bioavailability of Intranasal and Oral Esketamine and the Effects of Clarithromycin on the Pharmacokinetics of Intranasal Esketamine in Healthy Participants<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>01\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02568176\">NCT02568176<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>10\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02611505\">NCT02611505<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>11\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02606084\">NCT02606084<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>12\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02846519\">NCT02846519<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>02\/2016<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02682225\">NCT02682225<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>03\/2016<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02674295\">NCT02674295<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>03\/2016<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02737605\">NCT02737605<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Not yet recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>07\/2016<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02857777\">NCT02857777<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly Japanese, and Healthy Younger Adult Japanese Subjects<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Not yet recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>1<\/sup><\/td>\n<td valign=\"top\"><sup>08\/2016<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT01640080\">NCT01640080<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><strong><font color=\"#200020\"><sup>A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression<\/sup><\/font><\/strong><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>2<\/sup><\/td>\n<td valign=\"top\"><sup>06\/2012<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT01998958\">NCT01998958<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>2<\/sup><\/td>\n<td valign=\"top\"><sup>01\/2014<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02133001\">NCT02133001<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><strong><font color=\"#200020\"><sup>A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide<\/sup><\/font><\/strong><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#990000\">Completed<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>2<\/sup><\/td>\n<td valign=\"top\"><sup>05\/2014<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02417064\">NCT02417064<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>3<\/sup><\/td>\n<td valign=\"top\"><sup>08\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02418585\">NCT02418585<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>3<\/sup><\/td>\n<td valign=\"top\"><sup>08\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02422186\">NCT02422186<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>3<\/sup><\/td>\n<td valign=\"top\"><sup>08\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02497287\">NCT02497287<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>3<\/sup><\/td>\n<td valign=\"top\"><sup>09\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02493868\">NCT02493868<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>3<\/sup><\/td>\n<td valign=\"top\"><sup>10\/2015<\/sup><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><sup><a href=\"https:\/\/ClinicalTrials.gov\/show\/NCT02782104\">NCT02782104<\/a><\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup>A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant Depression<\/sup><\/td>\n<td valign=\"top\" align=\"left\"><sup><strong><font color=\"#009900\">Recruiting<\/font><\/strong><\/sup><\/td>\n<td valign=\"top\" align=\"center\"><sup>3<\/sup><\/td>\n<td valign=\"top\"><sup>06\/2016<\/sup><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>I don&#8217;t know anything about Ketamine except what I read. It is an FDA Approved off-patent anesthetic by day, and a club drug by night [Special K]. We began to hear about it as an antidepressant around the time that it became apparent that PHARMA was abandoning CNS drug development in 2012. It&#8217;s given iv [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-67548","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/67548","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=67548"}],"version-history":[{"count":50,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/67548\/revisions"}],"predecessor-version":[{"id":67703,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/67548\/revisions\/67703"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=67548"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=67548"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=67548"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}