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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.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\n            \u003Cp id=\u0022p-1\u0022\u003EArmodafinil 150 mg daily for 8 weeks as an adjuvant with mood stabilizers and\/or antipsychotic drugs improved depressive symptoms associated with bipolar I disorder. The benefits, however, were not statistically significant compared with placebo. The findings of a multi-institutional, international, Phase 3, randomized, double-blind, placebo-controlled trial are discussed in this article [APA 2014 (poster NR6-038); \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01305408\u0026amp;atom=%2Fspmdc%2F14%2F8%2F12.atom\u0022\u003ENCT01305408\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMood Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychopharmacology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMood Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychopharmacology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPsychiatry Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EArmodafinil 150 mg daily for 8 weeks as an adjuvant with mood stabilizers and\/or antipsychotic drugs improved depressive symptoms associated with bipolar I disorder. The benefits, however, were not statistically significant compared with placebo. The findings of a multi-institutional, international, Phase 3, randomized, double-blind, placebo-controlled trial were presented by Caleb Adler, MD, University of Cincinnati, Cincinnati, Ohio, USA [APA 2014 (poster NR6\u2013038); \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01305408\u0026amp;atom=%2Fspmdc%2F14%2F8%2F12.atom\u0022\u003ENCT01305408\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe study focused on depressive episodes of bipolar I disorder, which occur more frequently than the manic episodes [Kupka RW et al. \u003Cem\u003EBipolar Disord\u003C\/em\u003E 2007] and exact a toll on personal and work relationships [Calabrese JR et al. \u003Cem\u003EJ Clin Psychiatry\u003C\/em\u003E 2004]. The ability of armodafinil to bind to the dopamine transporter and inhibit dopamine reuptake [NUVIGIL (package insert). Frazer, PA: Cephalon, Inc; 2013] may be useful in treatment of bipolar I depression [Calabrese JR et al. \u003Cem\u003EJ Clin Psychiatry\u003C\/em\u003E 2010; Frye MA et al. \u003Cem\u003EAm J Psychiatry\u003C\/em\u003E 2007].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EResearchers screened 656 patients for the trial. All were aged 18 to 65 years, were diagnosed with bipolar I disorder, and were currently depressed for \u22652 weeks but \u226412 months despite a regimen of mood stabilizers for at least 4 weeks. Exclusion criteria included other Axis I or II disorders, psychotic symptoms or psychosis within 4 weeks of screening, suicidal ideation or a history of suicidal behavior, a Hamilton Anxiety Scale score \u226517 at baseline, and a documented drug or hypersensitivity reaction.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe 399 enrolled patients were randomly assigned to receive placebo (n=199) or armodafinil 150 mg\/day (n=200). At baseline, 308 (77%) of patients were taking one mood stabilizer or antipsychotic. Patients in the two groups were similar in baseline demographic and bipolar illness characteristics (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15831\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15831\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15831\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EBaseline Demographic and Bipolar Illness Characteristics\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EThe primary efficacy assessment was the mean change from baseline to 8 weeks in the 30-item, clinician-rated Inventory of Depressive Symptomatology (IDS-C\u003Csub\u003E30\u003C\/sub\u003E) score. Safety assessments included adverse events, serious adverse events, vital signs, and laboratory data.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe baseline mean IDS-C\u003Csub\u003E30\u003C\/sub\u003E scores were 42.4 and 43.5 in the armodafinil and placebo groups, respectively. The respective reduction in the score at 8 weeks was \u221220.8 and \u221219.4; the difference was not statistically significant (p=0.272). At 8 weeks, there were no clinically significant differences compared with baseline in serum chemistries, lipid profiles, and urinalysis parameters. Mean weight at 8 weeks was reduced in the armodafinil group by 0.5 kg and was increased in the placebo group by 0.3 kg.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EArmodafinil was well tolerated. Adverse events were similar in the two groups; most were mild or moderate, and no deaths occurred.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThe finding of a benefit of armodafinil that was not statistically significant from placebo calls for more research to conclusively determine the clinical value of the drug for treatment of bipolar I depression.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\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\/14\/8\/12.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_openurl.js?nzp80p\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_tables.js?nzp80p\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}