{"id":29687,"date":"2021-02-18T03:29:33","date_gmt":"2021-02-18T03:29:33","guid":{"rendered":"https:\/\/wames.org.uk\/cms-english\/?p=29687"},"modified":"2021-02-18T03:30:33","modified_gmt":"2021-02-18T03:30:33","slug":"open%e2%80%90label-study-with-the-monoamine-stabilizer-%e2%80%90%e2%80%90osu6162-in-me-cfs","status":"publish","type":"post","link":"https:\/\/wames.org.uk\/cms-english\/open%e2%80%90label-study-with-the-monoamine-stabilizer-%e2%80%90%e2%80%90osu6162-in-me-cfs\/","title":{"rendered":"Open\u2010label study with the monoamine stabilizer (\u2010)\u2010OSU6162 [drug] in ME\/CFS"},"content":{"rendered":"<h3><a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/full\/10.1002\/brb3.2040\" target=\"_blank\" rel=\"noopener\">Open\u2010label study with the monoamine stabilizer (\u2010)\u2010OSU6162 in myalgic encephalomyelitis\/ chronic fatigue syndrome<\/a>, by Sara Haghighi, Sara Forsmark, Olof Zachrisson, Arvid Carlsson, Marie K L Nilsson, Maria L Carlsson, Robert C Schuit, Carl\u2010Gerhard Gottfries <span style=\"text-decoration: underline;\">in<\/span> <em>Brain and Behavior,<\/em> 02 February 2021 [doi.org\/10.1002\/brb3.2040]<\/h3>\n<p>&nbsp;<\/p>\n<h3><strong>Research abstract:<\/strong><\/h3>\n<p><strong>Objectives<\/strong><\/p>\n<p><img data-recalc-dims=\"1\" decoding=\"async\" class=\"alignleft wp-image-23928 lazyload\" data-src=\"https:\/\/i0.wp.com\/wames.org.uk\/cms-english\/wp-content\/uploads\/2020\/01\/tablets-pink-bottle.jpg?resize=350%2C233&#038;ssl=1\" alt=\"\" width=\"350\" height=\"233\" data-srcset=\"https:\/\/i0.wp.com\/wames.org.uk\/cms-english\/wp-content\/uploads\/2020\/01\/tablets-pink-bottle.jpg?w=1280&amp;ssl=1 1280w, https:\/\/i0.wp.com\/wames.org.uk\/cms-english\/wp-content\/uploads\/2020\/01\/tablets-pink-bottle.jpg?resize=300%2C200&amp;ssl=1 300w, https:\/\/i0.wp.com\/wames.org.uk\/cms-english\/wp-content\/uploads\/2020\/01\/tablets-pink-bottle.jpg?resize=1024%2C683&amp;ssl=1 1024w, https:\/\/i0.wp.com\/wames.org.uk\/cms-english\/wp-content\/uploads\/2020\/01\/tablets-pink-bottle.jpg?resize=150%2C100&amp;ssl=1 150w, https:\/\/i0.wp.com\/wames.org.uk\/cms-english\/wp-content\/uploads\/2020\/01\/tablets-pink-bottle.jpg?resize=768%2C512&amp;ssl=1 768w, https:\/\/i0.wp.com\/wames.org.uk\/cms-english\/wp-content\/uploads\/2020\/01\/tablets-pink-bottle.jpg?resize=1536%2C1024&amp;ssl=1 1536w\" data-sizes=\"(max-width: 350px) 100vw, 350px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 350px; --smush-placeholder-aspect-ratio: 350\/233;\" \/>The purpose of the present study was to investigate the safety and tolerability of the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Monoaminergic\" target=\"_blank\" rel=\"noopener\">monoaminergic<\/a> stabilizer (\u2010)\u2010<a href=\"https:\/\/en.m.wikipedia.org\/wiki\/OSU-6162\" target=\"_blank\" rel=\"noopener\">OSU6162<\/a> in patients with myalgic encephalomyelitis\/chronic fatigue syndrome (ME\/CFS). In addition, a potential therapeutic effect of (\u2010)\u2010OSU6162 in ME\/CFS was evaluated by means of observer\u2010rated scales and self\u2010assessment rating scales.<\/p>\n<p><strong>Materials and Methods<\/strong><\/p>\n<p>In the current study using an <a href=\"https:\/\/en.wikipedia.org\/wiki\/Open-label_trial\" target=\"_blank\" rel=\"noopener\">open\u2010labe<\/a>l <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3059315\/\" target=\"_blank\" rel=\"noopener\">single\u2010arm design<\/a> ME\/CFS patient received treatment with (\u2010)\u2010OSU6162 during 12 weeks. The patients received the following doses of (\u2010)\u2010OSU6162: 15 mg b.i.d. during the first 4\u2010week period, up to 30 mg b.i.d. during the second 4\u2010week period and up to 45 mg b.i.d. during the third 4\u2010week period, with follow\u2010up visits after 16 and 20 weeks.<\/p>\n<p><strong>Results<\/strong><\/p>\n<p>Out of 33 included patients, 28 completed the 12 weeks treatment period. (\u2010)\u2010OSU6162 was well tolerated; only one patient discontinued due to an adverse event. Vital signs and physical examinations showed no abnormal changes. Blood analyses showed an increase in <a href=\"https:\/\/www.healthline.com\/health\/prolactin\" target=\"_blank\" rel=\"noopener\">serum prolactin<\/a>. Therapeutically, improvements were seen on the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Clinical_Global_Impression\" target=\"_blank\" rel=\"noopener\">Clinical Global Impression of Change scale<\/a>, the <a href=\"https:\/\/link.springer.com\/chapter\/10.1007\/978-1-4419-9893-4_37\" target=\"_blank\" rel=\"noopener\">FibroFatigue scale<\/a>, the <a href=\"https:\/\/www.longdom.org\/open-access\/evaluation-of-the-mental-fatigue-scale-and-its-relation-to-cognitive-and-emotional-functioning-after-traumatic-brain-injury-or-stroke-2329-9096.1000182.pdf\" target=\"_blank\" rel=\"noopener\">Mental Fatigue Scale<\/a>, the <a href=\"https:\/\/me-pedia.org\/wiki\/Fatigue_Severity_Scale\" target=\"_blank\" rel=\"noopener\">Fatigue Severity Scale<\/a>, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Beck_Depression_Inventory\" target=\"_blank\" rel=\"noopener\">Beck Depression Inventory<\/a>, and the <a href=\"https:\/\/me-pedia.org\/wiki\/Short_Form_36-Item_Health_Survey\" target=\"_blank\" rel=\"noopener\">Short Form 36 Health Survey<\/a> Questionnaire.<\/p>\n<p><strong>Conclusions<\/strong><\/p>\n<p>(\u2010)\u2010OSU6162 is well tolerated in ME\/CFS patients and shows promise as a novel treatment to mitigate fatigue and improve mood and health\u2010related quality of life in ME\/CFS. Obviously, the present results need to be confirmed in future placebo\u2010controlled double\u2010blind trials.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Open\u2010label study with the monoamine stabilizer (\u2010)\u2010OSU6162 in myalgic encephalomyelitis\/ chronic fatigue syndrome, by Sara Haghighi, Sara Forsmark, Olof Zachrisson, Arvid Carlsson, Marie K L Nilsson, Maria L Carlsson, Robert C Schuit, Carl\u2010Gerhard Gottfries in Brain and Behavior, 02 February &hellip; <a href=\"https:\/\/wames.org.uk\/cms-english\/open%e2%80%90label-study-with-the-monoamine-stabilizer-%e2%80%90%e2%80%90osu6162-in-me-cfs\/\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[1],"tags":[1415,6550,1560,6548,6549,6554,5275,6553,6555,6547,6551,6552],"class_list":["post-29687","post","type-post","status-publish","format-standard","hentry","category-news","tag-anti-depressant","tag-arvid-carlsson","tag-carl-gerhard-gottfries","tag-maria-l-carlsson","tag-marie-kl-nilsson","tag-monoamine-stabilizer","tag-olof-zachrisson","tag-osu6162","tag-prolactin","tag-robert-c-schuit","tag-sara-forsmark","tag-sara-haghighi"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p5qkYK-7IP","_links":{"self":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/29687","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/comments?post=29687"}],"version-history":[{"count":4,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/29687\/revisions"}],"predecessor-version":[{"id":29824,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/29687\/revisions\/29824"}],"wp:attachment":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/media?parent=29687"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/categories?post=29687"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/tags?post=29687"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}