Vortioxetine (Lu AA21004) in generalized anxiety disorder: Results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial
Abstract Vortioxetine is a multimodal antidepressant, with anxiolytic properties observed in preclinical studies. The goal of the current study was to evaluate the efficacy and tolerability of vortioxetine 5 mg vs placebo in adults with generalized anxiety disorder (GAD). Adults with a primary diagn...
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| Veröffentlicht in: | European neuropsychopharmacology 2012-12, Vol.22 (12), p.847-857 |
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| creator | Bidzan, Leszek Mahableshwarkar, Atul R Jacobsen, Paula Yan, Mingjin Sheehan, David V |
| description | Abstract Vortioxetine is a multimodal antidepressant, with anxiolytic properties observed in preclinical studies. The goal of the current study was to evaluate the efficacy and tolerability of vortioxetine 5 mg vs placebo in adults with generalized anxiety disorder (GAD). Adults with a primary diagnosis of GAD (HAM-A total score ≥20 and MADRS score ≤16) received vortioxetine 5 mg or placebo for 8 weeks. The primary efficacy endpoint was reduction in HAM-A total scores from baseline after 8 weeks of treatment compared with placebo. Key secondary measurements were HAD anxiety subscore, CGI-I, SDS total score, HAM-A response rates, HAM-A total score for subjects whose baseline HAM-A total score was ≥25, and SF-36 social functioning subscore. HAM-A remission rates were also measured. Adverse events (AEs) were assessed throughout the study. In total, 301 subjects (mean age, 45.2 years; 31% male) were randomized (1:1) to receive vortioxetine 5 mg ( n =150) or placebo ( n =151). After 8 weeks of treatment, there was a statistically significant difference in reduction from baseline in HAM-A total score for the vortioxetine group (−14.30) compared with placebo recipients (−10.49) ( P |
| doi_str_mv | 10.1016/j.euroneuro.2012.07.012 |
| format | Article |
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The goal of the current study was to evaluate the efficacy and tolerability of vortioxetine 5 mg vs placebo in adults with generalized anxiety disorder (GAD). Adults with a primary diagnosis of GAD (HAM-A total score ≥20 and MADRS score ≤16) received vortioxetine 5 mg or placebo for 8 weeks. The primary efficacy endpoint was reduction in HAM-A total scores from baseline after 8 weeks of treatment compared with placebo. Key secondary measurements were HAD anxiety subscore, CGI-I, SDS total score, HAM-A response rates, HAM-A total score for subjects whose baseline HAM-A total score was ≥25, and SF-36 social functioning subscore. HAM-A remission rates were also measured. Adverse events (AEs) were assessed throughout the study. In total, 301 subjects (mean age, 45.2 years; 31% male) were randomized (1:1) to receive vortioxetine 5 mg ( n =150) or placebo ( n =151). After 8 weeks of treatment, there was a statistically significant difference in reduction from baseline in HAM-A total score for the vortioxetine group (−14.30) compared with placebo recipients (−10.49) ( P <0.001). Statistically significant differences were observed for all key secondary outcomes favoring vortioxetine treatment (vs placebo), using a mixed model for repeated measurements (MMRM) analysis. Active treatment resulted in a significantly higher rate of remission. Vortioxetine was well tolerated. The most common treatment-related AEs were nausea, headache, dizziness, and dry mouth. In sum, vortioxetine was safe and effective in treating adults with GAD in this multinational population.</description><identifier>ISSN: 0924-977X</identifier><identifier>EISSN: 1873-7862</identifier><identifier>DOI: 10.1016/j.euroneuro.2012.07.012</identifier><identifier>PMID: 22898365</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Adult ; Age ; Anti-Anxiety Agents - therapeutic use ; Antidepressants ; Anxiety ; Anxiety Disorders - drug therapy ; Anxiety Disorders - epidemiology ; Anxiety Disorders - psychology ; Anxiolytics ; Bis-aryl-sulfanylamine ; Clinical trials ; Double-Blind Method ; Female ; Generalized anxiety disorder (GAD) ; Glutamate decarboxylase ; Headache ; Humans ; Internal Medicine ; Internationality ; Major depressive disorder (MDD) ; Male ; Middle Aged ; Mouth ; Multimodal ; Nausea ; Piperazines - therapeutic use ; Poland - epidemiology ; Psychiatry ; Remission ; Sodium lauryl sulfate ; Statistical analysis ; Sulfides - therapeutic use ; Time Factors ; Treatment Outcome</subject><ispartof>European neuropsychopharmacology, 2012-12, Vol.22 (12), p.847-857</ispartof><rights>Elsevier B.V. and ECNP</rights><rights>2012 Elsevier B.V. and ECNP</rights><rights>Copyright © 2012 Elsevier B.V. and ECNP. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c459t-310847d0cf2134f67ee9956cd8e924e0cf36cc4af9491230f618d4af8286d7403</citedby><cites>FETCH-LOGICAL-c459t-310847d0cf2134f67ee9956cd8e924e0cf36cc4af9491230f618d4af8286d7403</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0924977X12001940$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22898365$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bidzan, Leszek</creatorcontrib><creatorcontrib>Mahableshwarkar, Atul R</creatorcontrib><creatorcontrib>Jacobsen, Paula</creatorcontrib><creatorcontrib>Yan, Mingjin</creatorcontrib><creatorcontrib>Sheehan, David V</creatorcontrib><title>Vortioxetine (Lu AA21004) in generalized anxiety disorder: Results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial</title><title>European neuropsychopharmacology</title><addtitle>Eur Neuropsychopharmacol</addtitle><description>Abstract Vortioxetine is a multimodal antidepressant, with anxiolytic properties observed in preclinical studies. The goal of the current study was to evaluate the efficacy and tolerability of vortioxetine 5 mg vs placebo in adults with generalized anxiety disorder (GAD). Adults with a primary diagnosis of GAD (HAM-A total score ≥20 and MADRS score ≤16) received vortioxetine 5 mg or placebo for 8 weeks. The primary efficacy endpoint was reduction in HAM-A total scores from baseline after 8 weeks of treatment compared with placebo. Key secondary measurements were HAD anxiety subscore, CGI-I, SDS total score, HAM-A response rates, HAM-A total score for subjects whose baseline HAM-A total score was ≥25, and SF-36 social functioning subscore. HAM-A remission rates were also measured. Adverse events (AEs) were assessed throughout the study. In total, 301 subjects (mean age, 45.2 years; 31% male) were randomized (1:1) to receive vortioxetine 5 mg ( n =150) or placebo ( n =151). After 8 weeks of treatment, there was a statistically significant difference in reduction from baseline in HAM-A total score for the vortioxetine group (−14.30) compared with placebo recipients (−10.49) ( P <0.001). Statistically significant differences were observed for all key secondary outcomes favoring vortioxetine treatment (vs placebo), using a mixed model for repeated measurements (MMRM) analysis. Active treatment resulted in a significantly higher rate of remission. Vortioxetine was well tolerated. The most common treatment-related AEs were nausea, headache, dizziness, and dry mouth. In sum, vortioxetine was safe and effective in treating adults with GAD in this multinational population.</description><subject>Adult</subject><subject>Age</subject><subject>Anti-Anxiety Agents - therapeutic use</subject><subject>Antidepressants</subject><subject>Anxiety</subject><subject>Anxiety Disorders - drug therapy</subject><subject>Anxiety Disorders - epidemiology</subject><subject>Anxiety Disorders - psychology</subject><subject>Anxiolytics</subject><subject>Bis-aryl-sulfanylamine</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Generalized anxiety disorder (GAD)</subject><subject>Glutamate decarboxylase</subject><subject>Headache</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Internationality</subject><subject>Major depressive disorder (MDD)</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mouth</subject><subject>Multimodal</subject><subject>Nausea</subject><subject>Piperazines - therapeutic use</subject><subject>Poland - epidemiology</subject><subject>Psychiatry</subject><subject>Remission</subject><subject>Sodium lauryl sulfate</subject><subject>Statistical analysis</subject><subject>Sulfides - therapeutic use</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0924-977X</issn><issn>1873-7862</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUttuFDEMHSEQ3RZ-AfJYpJ0hl5lJwgPSqioXaSUkbuItyiYelG022SYz0OVX-Fky2rYPvMCLLdvHx7KPq-o5wQ3BpH-5bWBKMcymoZjQBvOmuAfVggjOai56-rBaYEnbWnL-7aQ6zXmLMekYk4-rE0qFFKzvFtXvrzGNLt7A6AKg8_WEVitKMG5fIBfQdwiQtHe_wCIdbhyMB2RdjslCeoU-Qp78mFEcShGJ-ifA1RLtSs4FXUiD9kuUdLBxNzMskY3TxkO98S6UaO-1gU2sTQxjit6XGaZUnNEejclp_6R6NGif4emtP6u-vLn8fPGuXn94-_5ita5N28mxZgSLlltsBkpYO_QcQMquN1ZA2R9KnvXGtHqQrSSU4aEnwpZQUNFb3mJ2Vp0fefcpXk-QR7Vz2YD3OkCcsiKUU84kw_LfUMJlKzgRXYHyI9SkmHOCQe2T2-l0UASrWUS1VfciqllEhbkqrnQ-ux0ybXZg7_vuVCuA1REA5So_HCSVjYNgwLoEZlQ2uv8Y8vovjrvjX8EB8jZOqehXNlK59KhP8y_Nr0RoeSNZrvYH7zDH_Q</recordid><startdate>20121201</startdate><enddate>20121201</enddate><creator>Bidzan, Leszek</creator><creator>Mahableshwarkar, Atul R</creator><creator>Jacobsen, Paula</creator><creator>Yan, Mingjin</creator><creator>Sheehan, David V</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7TK</scope></search><sort><creationdate>20121201</creationdate><title>Vortioxetine (Lu AA21004) in generalized anxiety disorder: Results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial</title><author>Bidzan, Leszek ; Mahableshwarkar, Atul R ; Jacobsen, Paula ; Yan, Mingjin ; Sheehan, David V</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c459t-310847d0cf2134f67ee9956cd8e924e0cf36cc4af9491230f618d4af8286d7403</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Age</topic><topic>Anti-Anxiety Agents - therapeutic use</topic><topic>Antidepressants</topic><topic>Anxiety</topic><topic>Anxiety Disorders - drug therapy</topic><topic>Anxiety Disorders - epidemiology</topic><topic>Anxiety Disorders - psychology</topic><topic>Anxiolytics</topic><topic>Bis-aryl-sulfanylamine</topic><topic>Clinical trials</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Generalized anxiety disorder (GAD)</topic><topic>Glutamate decarboxylase</topic><topic>Headache</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Internationality</topic><topic>Major depressive disorder (MDD)</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mouth</topic><topic>Multimodal</topic><topic>Nausea</topic><topic>Piperazines - therapeutic use</topic><topic>Poland - epidemiology</topic><topic>Psychiatry</topic><topic>Remission</topic><topic>Sodium lauryl sulfate</topic><topic>Statistical analysis</topic><topic>Sulfides - therapeutic use</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bidzan, Leszek</creatorcontrib><creatorcontrib>Mahableshwarkar, Atul R</creatorcontrib><creatorcontrib>Jacobsen, Paula</creatorcontrib><creatorcontrib>Yan, Mingjin</creatorcontrib><creatorcontrib>Sheehan, David V</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Neurosciences Abstracts</collection><jtitle>European neuropsychopharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bidzan, Leszek</au><au>Mahableshwarkar, Atul R</au><au>Jacobsen, Paula</au><au>Yan, Mingjin</au><au>Sheehan, David V</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Vortioxetine (Lu AA21004) in generalized anxiety disorder: Results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial</atitle><jtitle>European neuropsychopharmacology</jtitle><addtitle>Eur Neuropsychopharmacol</addtitle><date>2012-12-01</date><risdate>2012</risdate><volume>22</volume><issue>12</issue><spage>847</spage><epage>857</epage><pages>847-857</pages><issn>0924-977X</issn><eissn>1873-7862</eissn><abstract>Abstract Vortioxetine is a multimodal antidepressant, with anxiolytic properties observed in preclinical studies. The goal of the current study was to evaluate the efficacy and tolerability of vortioxetine 5 mg vs placebo in adults with generalized anxiety disorder (GAD). Adults with a primary diagnosis of GAD (HAM-A total score ≥20 and MADRS score ≤16) received vortioxetine 5 mg or placebo for 8 weeks. The primary efficacy endpoint was reduction in HAM-A total scores from baseline after 8 weeks of treatment compared with placebo. Key secondary measurements were HAD anxiety subscore, CGI-I, SDS total score, HAM-A response rates, HAM-A total score for subjects whose baseline HAM-A total score was ≥25, and SF-36 social functioning subscore. HAM-A remission rates were also measured. Adverse events (AEs) were assessed throughout the study. In total, 301 subjects (mean age, 45.2 years; 31% male) were randomized (1:1) to receive vortioxetine 5 mg ( n =150) or placebo ( n =151). After 8 weeks of treatment, there was a statistically significant difference in reduction from baseline in HAM-A total score for the vortioxetine group (−14.30) compared with placebo recipients (−10.49) ( P <0.001). Statistically significant differences were observed for all key secondary outcomes favoring vortioxetine treatment (vs placebo), using a mixed model for repeated measurements (MMRM) analysis. Active treatment resulted in a significantly higher rate of remission. Vortioxetine was well tolerated. The most common treatment-related AEs were nausea, headache, dizziness, and dry mouth. In sum, vortioxetine was safe and effective in treating adults with GAD in this multinational population.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>22898365</pmid><doi>10.1016/j.euroneuro.2012.07.012</doi><tpages>11</tpages></addata></record> |
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| ispartof | European neuropsychopharmacology, 2012-12, Vol.22 (12), p.847-857 |
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| subjects | Adult Age Anti-Anxiety Agents - therapeutic use Antidepressants Anxiety Anxiety Disorders - drug therapy Anxiety Disorders - epidemiology Anxiety Disorders - psychology Anxiolytics Bis-aryl-sulfanylamine Clinical trials Double-Blind Method Female Generalized anxiety disorder (GAD) Glutamate decarboxylase Headache Humans Internal Medicine Internationality Major depressive disorder (MDD) Male Middle Aged Mouth Multimodal Nausea Piperazines - therapeutic use Poland - epidemiology Psychiatry Remission Sodium lauryl sulfate Statistical analysis Sulfides - therapeutic use Time Factors Treatment Outcome |
| title | Vortioxetine (Lu AA21004) in generalized anxiety disorder: Results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial |
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