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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\u003Cp id=\u0022p-1\u0022\u003EAdults with attention deficit hyperactivity disorder may benefit from an oral regimen of dasotraline, which inhibits reuptake of dopamine and norepinephrine. Deficiencies of both compounds have been associated with attention deficit hyperactivity disorder symptoms. The 4-week, randomized, double-blind, placebo-controlled trial provided proof-of-concept for dasotraline use, and should prompt further clinical trials and dose optimization.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Edasotraline\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Edopamine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Enorepinephrine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EADHD\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einsomnia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epsychiatry \u0026amp; psychology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EA 4-week, randomized, double-blind, placebo-controlled trial [Koblan KS et al. \u003Cem\u003ENeuropsychopharmacology\u003C\/em\u003E. 2015] demonstrated clinically meaningful effects with dasotraline, an inhibitor of the reuptake of dopamine and norepinephrine, in the treatment of adults with attention-deficit\/hyperactivity disorder (ADHD).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ESymptoms of ADHD, including restlessness, impulsive behavior, forgetfulness, and distractibility, can hamper social interactions and work\/school performance, and ADHD that is first evident in childhood can continue into adulthood. Drugs that increase dopamine and norepinephrine transmission have proven clinical value in the management of ADHD symptoms. Dasotraline blocks the presynaptic reuptake of dopamine and norepinephrine, increasing their levels in the brain.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThis trial, conducted by Kenneth S. Koblan, PhD, Sunovion Pharmaceuticals, Marlborough, Massachusetts, USA, and colleagues, explored the potential value of dasotraline in adults with ADHD. Secondary objectives included evaluations of dasotraline safety and tolerability.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAdult outpatients aged 18 to 55 years (n\u2005=\u2005341) with a primary diagnosis of ADHD based on DSM-IV-TR criteria were randomized 1:1:1 in a double-blind fashion to a 4-week oral regimen of dasotraline 4 or 8 mg\/d, or to placebo. The treatment period was followed by a 2-week washout (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/11\/3\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Study DesignData presented in No. (%).DB, double-blind.Adapted by permission from Macmillan Publishers Ltd: Nerophsychopharmacology. Koblan KS et al. Dasotraline for the Treatment of Attention-Deficit\/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults. Advance online publication 3 June 2015; doi: 10.1038\/npp.2015.124. Copyright (2015).\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-991663098\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Study DesignData presented in No. (%).DB, double-blind.Adapted by permission from Macmillan Publishers Ltd: \u0026amp;lt;em\u0026amp;gt;Nerophsychopharmacology\u0026amp;lt;\/em\u0026amp;gt;. Koblan KS et al. Dasotraline for the Treatment of Attention-Deficit\/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults. Advance online publication 3 June 2015; doi: 10.1038\/npp.2015.124. Copyright (2015).\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/11\/3\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/11\/3\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/11\/3\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16872\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EStudy Design\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EData presented in No. (%).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EDB, double-blind.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EAdapted by permission from Macmillan Publishers Ltd: \u003Cem\u003ENerophsychopharmacology\u003C\/em\u003E. Koblan KS et al. Dasotraline for the Treatment of Attention-Deficit\/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults. Advance online publication 3 June 2015; doi: 10.1038\/npp.2015.124. Copyright (2015).\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EInclusion criteria other than diagnosis of ADHD included prior treatment with at least one ADHD medication (stimulant or nonstimulant), and a Clinical Global Impression, Severity (CGI-S) score \u2265\u20054 at baseline. Exclusion criteria were history of bipolar disorder, schizophrenia, or other psychotic disorder; substance abuse\/dependence in the prior 12 months, or a positive alcohol or drug screen test result during trial screening; and treatment in the preceding 6 months with specified medications. Use of zolpidem, zaleplon, and eszopiclone for insomnia management was allowed.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThe intention-to-treat arms for dasotraline 4 mg, 8 mg, and placebo were demographically\/clinically comparable at baseline. The primary outcome of mean change from baseline in the ADHD Rating Scale, version IV score at 4 weeks was reduced by dasotraline 4 and 8 mg vs placebo (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/11\/3\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Primary OutcomeThe primary efficacy measure of ADHD RS-IV (with adult prompts) total score was reduced by dasotraline 4 mg (adjusted P\u0026#x2005;=\u0026#x2005;.076) and 8 mg (adjusted P\u0026#x2005;=\u0026#x2005;.019) at 4 wk compared with placebo.ADHD RS-IV, Attention Deficit Hyperactivity Disorder Rating Scale version IV; LS, least squares.aBaseline mean, 36.8.bBaseline mean, 36.6.cBaseline mean, 36.7.*P\u0026#x2005;\u0026amp;lt;\u0026#x2005;.05.Adapted by permission from Macmillan Publishers Ltd: Nerophsychopharmacology. Koblan KS et al. Dasotraline for the Treatment of Attention-Deficit\/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults. Advance online publication 3 June 2015; doi: 10.1038\/npp.2015.124. Copyright (2015).\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-991663098\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Primary OutcomeThe primary efficacy measure of ADHD RS-IV (with adult prompts) total score was reduced by dasotraline 4 mg (adjusted \u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt;\u0026#x2005;=\u0026#x2005;.076) and 8 mg (adjusted \u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt;\u0026#x2005;=\u0026#x2005;.019) at 4 wk compared with placebo.ADHD RS-IV, Attention Deficit Hyperactivity Disorder Rating Scale version IV; LS, least squares.\u0026amp;lt;sup\u0026amp;gt;a\u0026amp;lt;\/sup\u0026amp;gt;Baseline mean, 36.8.\u0026amp;lt;sup\u0026amp;gt;b\u0026amp;lt;\/sup\u0026amp;gt;Baseline mean, 36.6.\u0026amp;lt;sup\u0026amp;gt;c\u0026amp;lt;\/sup\u0026amp;gt;Baseline mean, 36.7.\u0026amp;lt;sup\u0026amp;gt;*\u0026amp;lt;\/sup\u0026amp;gt;\u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt;\u0026#x2005;\u0026amp;amp;lt;\u0026#x2005;.05.Adapted by permission from Macmillan Publishers Ltd: \u0026amp;lt;em\u0026amp;gt;Nerophsychopharmacology\u0026amp;lt;\/em\u0026amp;gt;. Koblan KS et al. Dasotraline for the Treatment of Attention-Deficit\/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults. Advance online publication 3 June 2015; doi: 10.1038\/npp.2015.124. Copyright (2015).\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/11\/3\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/11\/3\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/11\/3\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16873\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \u003Cp id=\u0022p-12\u0022 class=\u0022first-child\u0022\u003EPrimary Outcome\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EThe primary efficacy measure of ADHD RS-IV (with adult prompts) total score was reduced by dasotraline 4 mg (adjusted \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.076) and 8 mg (adjusted \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.019) at 4 wk compared with placebo.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EADHD RS-IV, Attention Deficit Hyperactivity Disorder Rating Scale version IV; LS, least squares.\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003E\u003Csup\u003Ea\u003C\/sup\u003EBaseline mean, 36.8.\u003C\/p\u003E\u003Cp id=\u0022p-16\u0022\u003E\u003Csup\u003Eb\u003C\/sup\u003EBaseline mean, 36.6.\u003C\/p\u003E\u003Cp id=\u0022p-17\u0022\u003E\u003Csup\u003Ec\u003C\/sup\u003EBaseline mean, 36.7.\u003C\/p\u003E\u003Cp id=\u0022p-18\u0022\u003E\u003Csup\u003E*\u003C\/sup\u003E\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.05.\u003C\/p\u003E\u003Cp id=\u0022p-19\u0022\u003EAdapted by permission from Macmillan Publishers Ltd: \u003Cem\u003ENerophsychopharmacology\u003C\/em\u003E. Koblan KS et al. Dasotraline for the Treatment of Attention-Deficit\/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults. Advance online publication 3 June 2015; doi: 10.1038\/npp.2015.124. Copyright (2015).\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-20\u0022\u003EBoth doses of dasotraline significantly improved the CGI-S score compared with placebo at 4 weeks (4 mg, \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.021; 8 mg, \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.013). Significant improvements in the hyperactivity\/impulsivity (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.027) and inattentiveness (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.016) subscales were also evident with the 8 mg dose arm.\u003C\/p\u003E\u003Cp id=\u0022p-21\u0022\u003EAdverse events that occurred more often in those receiving dasotraline included insomnia, decreased appetite, anxiety, nausea, and dizziness. Events leading to patient withdrawal for the 4 and 8 mg doses of dasotraline were insomnia (2.6% and 10.8%), anxiety (2.6% and 1.8%), and panic attacks (0% and 2.7%); these events did not occur in the placebo arm. The mean changes in the Insomnia Severity Index scores for both doses of dasotraline were significantly higher at weeks 1 through 4 compared with placebo.\u003C\/p\u003E\u003Cp id=\u0022p-22\u0022\u003EThe proof-of-concept trial demonstrated clinically meaningful benefits in adults with ADHD using dasotraline, with benefits being significantly better than placebo for the 8 mg dose. The observation of increased plasma levels of the norepinephrine metabolite dihydroxyphenylglycol with increasing dasotraline dose supports the view that the drug\u2019s beneficial effects reflect inhibition of dopamine and norepinephrine reuptake. Further clinical trials, including dose optimization, are anticipated.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/11\/3.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzli82\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzli82\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}