{"id":17465,"date":"2022-06-08T15:25:06","date_gmt":"2022-06-08T14:25:06","guid":{"rendered":"https:\/\/psychedelichealth.co.uk\/?p=17465"},"modified":"2022-06-08T15:32:00","modified_gmt":"2022-06-08T14:32:00","slug":"ketamine-study-resistant-depression-doses-patient","status":"publish","type":"post","link":"https:\/\/psychedelichealth.co.uk\/2022\/06\/08\/ketamine-study-resistant-depression-doses-patient\/","title":{"rendered":"Ketamine study for resistant depression doses first patient"},"content":{"rendered":"<h3 class=\"p1\"><b>The first patient has been dosed in HMNC and Develco Pharma\u2019s Phase 2 oral prolonged-release Ketamine (KET01) Study.<\/b><\/h3>\n<p class=\"p1\">According to <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0165032720330585#:~:text=Treatment%20resistant%20depression%20(TRD%3B%20failure,major%20depressive%20disorder%20(MDD).\" target=\"_blank\" rel=\"noopener\">real-world data<\/a> from Europe, TRD affects ~20 per cent of patients with major depressive disorder (MDD). People living with TRD have a <a href=\"https:\/\/bmcpsychiatry.biomedcentral.com\/articles\/10.1186\/s12888-019-2222-4\" target=\"_blank\" rel=\"noopener\">significantly lower quality of life<\/a>, use more health rescues and have decreased work productivity and general activity.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p>\n<p class=\"p1\">To understand if ketamine can help this population of patients, <a href=\"https:\/\/www.hmnc-brainhealth.com\/\" target=\"_blank\" rel=\"noopener\">HMNC<\/a>\u2019s trial will enrol 117 patients who have not responded to a minimum of two standard antidepressants in their current major depressive episode.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p>\n<div style=\"clear:both; margin-top:0em; margin-bottom:1em;\"><a href=\"https:\/\/psychedelichealth.co.uk\/2021\/12\/16\/hmnc-precision-medicine-psychiatric-care\/\" target=\"_blank\" rel=\"dofollow\" class=\"uf2b444bb24780566020c1b95cd03b501\"><style> .uf2b444bb24780566020c1b95cd03b501 { padding:0px; margin: 0; padding-top:1em!important; padding-bottom:1em!important; width:100%; display: block; font-weight:bold; background-color:#eaeaea; border:0!important; border-left:4px solid #34495E!important; text-decoration:none; } .uf2b444bb24780566020c1b95cd03b501:active, .uf2b444bb24780566020c1b95cd03b501:hover { opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; text-decoration:none; } .uf2b444bb24780566020c1b95cd03b501 { transition: background-color 250ms; webkit-transition: background-color 250ms; opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; } .uf2b444bb24780566020c1b95cd03b501 .ctaText { font-weight:bold; color:inherit; text-decoration:none; font-size: 16px; } .uf2b444bb24780566020c1b95cd03b501 .postTitle { color:#000000; text-decoration: underline!important; font-size: 16px; } .uf2b444bb24780566020c1b95cd03b501:hover .postTitle { text-decoration: underline!important; } <\/style><div style=\"padding-left:1em; padding-right:1em;\"><span class=\"ctaText\">See also<\/span>&nbsp; <span class=\"postTitle\">HMNC: pioneering precision medicine for psychiatric care<\/span><\/div><\/a><\/div>\n<p class=\"p1\">It will be carried out across 38 clinical sites, and is expected to confirm the results of the previous trial, with early-onset of efficacy, showing placebo-level dissociative side effects and high tolerability, which HMNC says furthers the take-at-home potential of this novel treatment.<\/p>\n<p class=\"p1\">Chief Medical Officer\u00a0at HMNC Brain Health, Dr Hans Eriksson, commented: \u201cOur first investigator-initiated Phase 2 Proof of concept trial, which we announced the preliminary results for at the end of March, suggested a positive trend in efficacy for KET01, which appears to be a safe and well-tolerated antidepressant with substantially limited dissociative side effects.\u201d<\/p>\n<p class=\"p1\">Trial participants will be randomised into three treatment groups and will either receive a placebo, KET01 120 mg, or KET01 240 mg once daily (OD), in addition to their ongoing standard antidepressant treatment over a period of three weeks.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p>\n<p class=\"p1\">The primary endpoint is the change on the established Montgomery\u2013\u00c5sberg Depression Rating Scale (MADRS) for depressive severity at day 21 compared to placebo.<\/p>\n<p class=\"p1\">HMNC Brain Health CEO, Benedikt von Braunm\u00fchl, added: \u201cWe are very pleased to have achieved this important milestone in the development of KET01 for Treatment-Resistant Depression. We believe KET01 has the potential to improve the lives of patients who are not responding to standard antidepressant therapies, and we are looking forward to further develop this potential medication with the insights generated from this trial\u201d.<\/p>\n<p class=\"p1\">Topline data from the study is expected to be reported in the second quarter of 2023. The Ketabon program, which is a joint venture between HMNC Brain Health and Swiss-based Develco Pharma, funded the trial.<\/p>\n<p>[activecampaign form=52]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The trial will assess the efficacy, safety and tolerability of add-on treatment with KET01 in 117 patients suffering from Treatment-Resistant Depression (TRD).<\/p>\n","protected":false},"author":20,"featured_media":17466,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_cbd_carousel_blocks":"[]","content-type":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[215],"tags":[95,48,226],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v18.1 (Yoast SEO v22.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Ketamine study for resistant depression doses first 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