{"id":56760,"date":"2015-05-12T10:00:10","date_gmt":"2015-05-12T14:00:10","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=56760"},"modified":"2015-05-12T09:32:38","modified_gmt":"2015-05-12T13:32:38","slug":"56760","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/05\/12\/56760\/","title":{"rendered":"prelapse: prequel<sub>1<\/sub>&#8230;"},"content":{"rendered":"\n<p align=\"justify\" class=\"small\">It&#8217;s not easy to talk about the condition we call Schizophrenia these days. Much of the controversy is about long the term management, giving antipsychotic medication not to treat an existing problem, but rather to prevent relapses &#8211; the chronic treatment of the chronic patient. Our existing antipsychotic medications aren&#8217;t much fun to take &#8211; having side effects, and in some cases, irreversible and debilitating side effects. On the other hand, maintenance antipsychotics do significantly decrease the incidence of relapse. And the tendency of patients with Schizophrenic illness to spontaneously stop taking medications is legendary. Anyone reading this likely has an opinion about how to deal with maintenance antipsychotics, and mercifully, that&#8217;s not what this post is about so we can table that particular rhetoric and its usual discord for the moment.<\/p>\n<p align=\"justify\" class=\"small\">One solution is to use depot antipsychotics meaning the patient gets a shot monthly rather than pill[s] daily. And in some instances, these depot injections have been court ordered &#8211; known as a form of the &quot;forced drugging&quot; bitterly opposed by many activists. Again, not exactly the topic here, but it&#8217;s getting closer. I think almost all of us agree that the first episode of Schizophrenia is a special case. While the course up ahead is&nbsp; unknown, most feel that our best chance of preventing a downhill course of illness is in how we handle that initial episode [we&#8217;d like to keep a psychotic break from ever happening at all, but efforts in that sphere have yet to bear fruit]. And that brings us to a case most of us know pretty well by now &#8211; Dan Markingson [his story is <a target=\"_blank\" href=\"http:\/\/markingson.blogspot.com\/\">here<\/a>].<\/p>\n<p align=\"justify\" class=\"small\">Putting aside all the tragedy of that story for the moment, Dan was in a study for patients having their first episode of psychosis [CAFE]. It was a fairly straight-forward trial. The patients were blindly assigned to one of three Atypical Antipsychotics and followed for a year. You left the study one of three ways: <font color=\"#200020\">Completion<\/font>; <font color=\"#200020\">Voluntary Withdrawal<\/font>;<font color=\"#200020\"> Removed by a clinician [non-response]<\/font>. This study was a clone of an earlier NIMH study, CATIE, except CAFE was acute rather than chronic cases. But that&#8217;s a big difference. The chronic patients in CATIE were known antipsychotic responders put on medication to see how long they would take it &#8211; a tolerability study. I can&#8217;t imagine treating a person with a first break with an unknown medication and dose. Treating an acute episode means adjusting the dose or changing drugs based on the response. I wouldn&#8217;t mind the patient or rater being blinded, but not the clinician. Had I been on the IRB, I&#8217;m sure I would&#8217;ve voted &quot;<em><strong><font color=\"#200020\">no<\/font><\/strong><\/em>.&quot;<\/p>\n<div align=\"justify\" class=\"small\">By my read of Dan&#8217;s case, he didn&#8217;t ever really respond to the medication, and after six months, he suicided &#8211; a tragedy that might have been prevented had his doctors been more vigilant and done the usual playing with medication and dose until they found something that worked. While that might not have worked, it was certainly a real possibility that was never tried &#8211; and if he hadn&#8217;t been in that study, it would&#8217;ve surely been attempted. And that brings us to another study in the works &#8211; <strong>PRELAPSE<\/strong> &#8211; the real topic of this post. Here&#8217;s the blurb from Clinicaltrials.gov: <\/div>\n<blockquote>\n<div align=\"center\" class=\"middle\"><a target=\"_blank\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02360319\">Comparison of a Long-acting Injectable  Antipsychotic vs Clinician&#8217;s Choice<\/a><\/div>\n<div align=\"center\" class=\"middle\"><a target=\"_blank\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02360319\">Early in Treatment to Break the  Cycle of Relapse in Early Phase Schizophrenics<\/a><br \/>        [PRELAPSE]<br \/>        NCT02360319<\/div>\n<p>        <\/p>\n<div align=\"justify\">The goal of this project is to show that the best possible option for  preventing relapses in patients suffering from first episode [&lt;1 year  of anti-psychotic medication] or early phase [&lt;5 years of lifetime  exposure to anti-psychotic medication] schizophrenia is by enhancing  medication adherence. The study is designed to answer the question of  whether the use of long-acting injectable [LAI] antipsychotics early in  the course of treatment can break the cycle of frequent relapse that  affects so many patients with early phase schizophrenia. The  participating research sites [not individual patients] will be randomly  assigned to either medication prescribed by their treating physician  [with no restrictions] or to a regimen that involves a monthly long  acting injectable antipsychotic. The sites will be assigned on a one to  one basis to either of the arms taking into account types of patient  population and geographical area. Patients enrolled in the study will  participate in regular assessments either over the phone or in person  and be followed for a period of 2 years. The primary outcome measure is  time to first hospitalization.<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\"><img loading=\"lazy\" decoding=\"async\" width=\"260\" vspace=\"3\" hspace=\"4\" height=\"130\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/abilify-18.gif\" \/>The drug here is <font color=\"#200020\">Abilify Maintena<\/font><font color=\"#200020\">&reg;<\/font>, the depot form of <font color=\"#200020\">Abilify&reg;<\/font> [<font color=\"#200020\">Aripiprazole<\/font>]. So the study brings up two semi-separate issues: the use of depot medications to deal with medication compliance and the treatment of a first episode of Schizophrenia with a fixed dose of depot medication. This is a stopping place, but there&#8217;s more to come&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>It&#8217;s not easy to talk about the condition we call Schizophrenia these days. Much of the controversy is about long the term management, giving antipsychotic medication not to treat an existing problem, but rather to prevent relapses &#8211; the chronic treatment of the chronic patient. Our existing antipsychotic medications aren&#8217;t much fun to take &#8211; [&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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-56760","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56760","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=56760"}],"version-history":[{"count":31,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56760\/revisions"}],"predecessor-version":[{"id":56814,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56760\/revisions\/56814"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=56760"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=56760"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=56760"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}