A Double-Blind, Placebo-Controlled Comparator Study of LY2140023 monohydrate in patients with schizophrenia
Pomaglumetad methionil (LY2140023 monohydrate) is a potent and highly selective agonist for the metabotropic glutamate mGluR2 and mGluR3 receptors. We present results of a pivotal clinical study H8Y-MC-HBBM assessing the efficacy of LY2140023 in improving symptoms as a monotherapy in patients with a...
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| Veröffentlicht in: | BMC psychiatry 2014-12, Vol.14 (1), p.351-351, Article 351 |
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| creator | Downing, AnnCatherine M Kinon, Bruce J Millen, Brian A Zhang, Lu Liu, Lin Morozova, Margarita A Brenner, Ronald Rayle, Tami Jo Nisenbaum, Laura Zhao, Fangyi Gomez, Juan Carlos |
| description | Pomaglumetad methionil (LY2140023 monohydrate) is a potent and highly selective agonist for the metabotropic glutamate mGluR2 and mGluR3 receptors. We present results of a pivotal clinical study H8Y-MC-HBBM assessing the efficacy of LY2140023 in improving symptoms as a monotherapy in patients with an acute exacerbation of schizophrenia.
Enrolled adult patients (ages 18-65) with schizophrenia who had experienced an exacerbation of symptoms within 2 weeks prior to study entry. Patients (N = 1013) were randomized 2:2:2:1 to treatment with placebo, LY40 mg twice daily (BID), LY80 mg BID, or risperidone (RIS) 2 mg BID for 6 weeks after a one-week blinded placebo lead-in. The primary outcome assessed change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in an overall schizophrenia population and a predefined subpopulation which excluded non-Hispanic white patients with the A/A genotype at the HTR2A SNP rs7330461.
Neither LY2140023 dose showed significant improvement compared to placebo on PANSS total in either population (1-sided p-value [significance level], overall: LY40, p = .154 [0.01]; LY80, p = .698 [0.01], subpopulation: LY40, p = .033 [0.0025]; LY80, p = .659 [0.0025], MMRM analysis). RIS statistically separated from placebo in both populations (p |
| doi_str_mv | 10.1186/s12888-014-0351-3 |
| format | Article |
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Enrolled adult patients (ages 18-65) with schizophrenia who had experienced an exacerbation of symptoms within 2 weeks prior to study entry. Patients (N = 1013) were randomized 2:2:2:1 to treatment with placebo, LY40 mg twice daily (BID), LY80 mg BID, or risperidone (RIS) 2 mg BID for 6 weeks after a one-week blinded placebo lead-in. The primary outcome assessed change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in an overall schizophrenia population and a predefined subpopulation which excluded non-Hispanic white patients with the A/A genotype at the HTR2A SNP rs7330461.
Neither LY2140023 dose showed significant improvement compared to placebo on PANSS total in either population (1-sided p-value [significance level], overall: LY40, p = .154 [0.01]; LY80, p = .698 [0.01], subpopulation: LY40, p = .033 [0.0025]; LY80, p = .659 [0.0025], MMRM analysis). RIS statistically separated from placebo in both populations (p < .001 [0.05]). There were no statistically significant differences in the incidence of serious adverse events, and no seizures on LY2140023.
LY2140023 treatment did not demonstrate efficacy in populations studied. Overall, LY2140023 treatment was generally well tolerated with no new adverse safety findings compared to previous trials. Further understanding of the role of glutamate as a therapeutic target in schizophrenia is needed.
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR SchizophreniaClinicalTrials.gov identifier: NCT01086748.</description><identifier>ISSN: 1471-244X</identifier><identifier>EISSN: 1471-244X</identifier><identifier>DOI: 10.1186/s12888-014-0351-3</identifier><identifier>PMID: 25539791</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adult ; Aged ; Amino Acids - administration & dosage ; Analysis ; Antipsychotic Agents - administration & dosage ; Dopamine Antagonists - administration & dosage ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Female ; Humans ; Hypotheses ; Male ; Medical research ; Methods ; Middle Aged ; Pharmaceutical industry ; Psychiatric Status Rating Scales ; Psychiatry ; Receptors, Metabotropic Glutamate - agonists ; Risperidone - administration & dosage ; Schizophrenia ; Schizophrenia - drug therapy ; Studies ; Treatment Outcome ; Young Adult</subject><ispartof>BMC psychiatry, 2014-12, Vol.14 (1), p.351-351, Article 351</ispartof><rights>COPYRIGHT 2014 BioMed Central Ltd.</rights><rights>2014 Downing et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c472t-56139ce524c4d3fc42e63d9809879a6d737ad25398666db920497a9ebceb279e3</citedby><cites>FETCH-LOGICAL-c472t-56139ce524c4d3fc42e63d9809879a6d737ad25398666db920497a9ebceb279e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,860,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25539791$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Downing, AnnCatherine M</creatorcontrib><creatorcontrib>Kinon, Bruce J</creatorcontrib><creatorcontrib>Millen, Brian A</creatorcontrib><creatorcontrib>Zhang, Lu</creatorcontrib><creatorcontrib>Liu, Lin</creatorcontrib><creatorcontrib>Morozova, Margarita A</creatorcontrib><creatorcontrib>Brenner, Ronald</creatorcontrib><creatorcontrib>Rayle, Tami Jo</creatorcontrib><creatorcontrib>Nisenbaum, Laura</creatorcontrib><creatorcontrib>Zhao, Fangyi</creatorcontrib><creatorcontrib>Gomez, Juan Carlos</creatorcontrib><title>A Double-Blind, Placebo-Controlled Comparator Study of LY2140023 monohydrate in patients with schizophrenia</title><title>BMC psychiatry</title><addtitle>BMC Psychiatry</addtitle><description>Pomaglumetad methionil (LY2140023 monohydrate) is a potent and highly selective agonist for the metabotropic glutamate mGluR2 and mGluR3 receptors. We present results of a pivotal clinical study H8Y-MC-HBBM assessing the efficacy of LY2140023 in improving symptoms as a monotherapy in patients with an acute exacerbation of schizophrenia.
Enrolled adult patients (ages 18-65) with schizophrenia who had experienced an exacerbation of symptoms within 2 weeks prior to study entry. Patients (N = 1013) were randomized 2:2:2:1 to treatment with placebo, LY40 mg twice daily (BID), LY80 mg BID, or risperidone (RIS) 2 mg BID for 6 weeks after a one-week blinded placebo lead-in. The primary outcome assessed change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in an overall schizophrenia population and a predefined subpopulation which excluded non-Hispanic white patients with the A/A genotype at the HTR2A SNP rs7330461.
Neither LY2140023 dose showed significant improvement compared to placebo on PANSS total in either population (1-sided p-value [significance level], overall: LY40, p = .154 [0.01]; LY80, p = .698 [0.01], subpopulation: LY40, p = .033 [0.0025]; LY80, p = .659 [0.0025], MMRM analysis). RIS statistically separated from placebo in both populations (p < .001 [0.05]). There were no statistically significant differences in the incidence of serious adverse events, and no seizures on LY2140023.
LY2140023 treatment did not demonstrate efficacy in populations studied. Overall, LY2140023 treatment was generally well tolerated with no new adverse safety findings compared to previous trials. Further understanding of the role of glutamate as a therapeutic target in schizophrenia is needed.
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR SchizophreniaClinicalTrials.gov identifier: NCT01086748.</description><subject>Adult</subject><subject>Aged</subject><subject>Amino Acids - administration & dosage</subject><subject>Analysis</subject><subject>Antipsychotic Agents - administration & dosage</subject><subject>Dopamine Antagonists - administration & dosage</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Humans</subject><subject>Hypotheses</subject><subject>Male</subject><subject>Medical research</subject><subject>Methods</subject><subject>Middle Aged</subject><subject>Pharmaceutical industry</subject><subject>Psychiatric Status Rating Scales</subject><subject>Psychiatry</subject><subject>Receptors, Metabotropic Glutamate - agonists</subject><subject>Risperidone - administration & dosage</subject><subject>Schizophrenia</subject><subject>Schizophrenia - drug therapy</subject><subject>Studies</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1471-244X</issn><issn>1471-244X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkkuPFCEUhStG4zz0B7gxJG5cTI1coApYtj2jTtKJJmqiK0IBZTNWQQ1UxfT8eun0-IwLw-IS7nduzg2nqp4APgcQ7YsMRAhRY2A1pg3U9F51DIxDTRj7dP-3-1F1kvM1xsBFAw-rI9I0VHIJx9XXFbqISze4-uXggz1D7wZtXBfrdQxzisPgLFrHcdJJzzGh9_Nidyj2aPOZAMOYUDTGELc7W_oO-YAmPXsX5oy--XmLstn62zhtkwteP6oe9HrI7vFdPa0-vrr8sH5Tb96-vlqvNrVhnMx10wKVxjWEGWZpbxhxLbVSYCm41K3llGtLygKibVvbSYKZ5Fq6rvgmXDp6Wj0_zJ1SvFlcntXos3HDoIOLS1bQMo6BEEH-BwUMQrC2oM_-Qq_jkkJZZE9hoLyR5Bf1RQ9O-dDHOWmzH6pWxXIjsQRWqPN_UOVYN3oTg-t9ef9DAAeBSTHn5Ho1JT_qtFOA1T4L6pAFVbKg9llQtGie3hleutHZn4ofn0-_A-wXq00</recordid><startdate>20141210</startdate><enddate>20141210</enddate><creator>Downing, AnnCatherine M</creator><creator>Kinon, Bruce J</creator><creator>Millen, Brian A</creator><creator>Zhang, Lu</creator><creator>Liu, Lin</creator><creator>Morozova, Margarita A</creator><creator>Brenner, Ronald</creator><creator>Rayle, Tami Jo</creator><creator>Nisenbaum, Laura</creator><creator>Zhao, Fangyi</creator><creator>Gomez, Juan Carlos</creator><general>BioMed Central Ltd</general><general>BioMed Central</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>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20141210</creationdate><title>A Double-Blind, Placebo-Controlled Comparator Study of LY2140023 monohydrate in patients with schizophrenia</title><author>Downing, AnnCatherine M ; Kinon, Bruce J ; Millen, Brian A ; Zhang, Lu ; Liu, Lin ; Morozova, Margarita A ; Brenner, Ronald ; Rayle, Tami Jo ; Nisenbaum, Laura ; Zhao, Fangyi ; Gomez, Juan Carlos</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c472t-56139ce524c4d3fc42e63d9809879a6d737ad25398666db920497a9ebceb279e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Amino Acids - administration & dosage</topic><topic>Analysis</topic><topic>Antipsychotic Agents - administration & dosage</topic><topic>Dopamine Antagonists - administration & dosage</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Humans</topic><topic>Hypotheses</topic><topic>Male</topic><topic>Medical research</topic><topic>Methods</topic><topic>Middle Aged</topic><topic>Pharmaceutical industry</topic><topic>Psychiatric Status Rating Scales</topic><topic>Psychiatry</topic><topic>Receptors, Metabotropic Glutamate - agonists</topic><topic>Risperidone - administration & dosage</topic><topic>Schizophrenia</topic><topic>Schizophrenia - drug therapy</topic><topic>Studies</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Downing, AnnCatherine M</creatorcontrib><creatorcontrib>Kinon, Bruce J</creatorcontrib><creatorcontrib>Millen, Brian A</creatorcontrib><creatorcontrib>Zhang, Lu</creatorcontrib><creatorcontrib>Liu, Lin</creatorcontrib><creatorcontrib>Morozova, Margarita A</creatorcontrib><creatorcontrib>Brenner, Ronald</creatorcontrib><creatorcontrib>Rayle, Tami Jo</creatorcontrib><creatorcontrib>Nisenbaum, Laura</creatorcontrib><creatorcontrib>Zhao, Fangyi</creatorcontrib><creatorcontrib>Gomez, Juan Carlos</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>BMC psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Downing, AnnCatherine M</au><au>Kinon, Bruce J</au><au>Millen, Brian A</au><au>Zhang, Lu</au><au>Liu, Lin</au><au>Morozova, Margarita A</au><au>Brenner, Ronald</au><au>Rayle, Tami Jo</au><au>Nisenbaum, Laura</au><au>Zhao, Fangyi</au><au>Gomez, Juan Carlos</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Double-Blind, Placebo-Controlled Comparator Study of LY2140023 monohydrate in patients with schizophrenia</atitle><jtitle>BMC psychiatry</jtitle><addtitle>BMC Psychiatry</addtitle><date>2014-12-10</date><risdate>2014</risdate><volume>14</volume><issue>1</issue><spage>351</spage><epage>351</epage><pages>351-351</pages><artnum>351</artnum><issn>1471-244X</issn><eissn>1471-244X</eissn><abstract>Pomaglumetad methionil (LY2140023 monohydrate) is a potent and highly selective agonist for the metabotropic glutamate mGluR2 and mGluR3 receptors. We present results of a pivotal clinical study H8Y-MC-HBBM assessing the efficacy of LY2140023 in improving symptoms as a monotherapy in patients with an acute exacerbation of schizophrenia.
Enrolled adult patients (ages 18-65) with schizophrenia who had experienced an exacerbation of symptoms within 2 weeks prior to study entry. Patients (N = 1013) were randomized 2:2:2:1 to treatment with placebo, LY40 mg twice daily (BID), LY80 mg BID, or risperidone (RIS) 2 mg BID for 6 weeks after a one-week blinded placebo lead-in. The primary outcome assessed change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in an overall schizophrenia population and a predefined subpopulation which excluded non-Hispanic white patients with the A/A genotype at the HTR2A SNP rs7330461.
Neither LY2140023 dose showed significant improvement compared to placebo on PANSS total in either population (1-sided p-value [significance level], overall: LY40, p = .154 [0.01]; LY80, p = .698 [0.01], subpopulation: LY40, p = .033 [0.0025]; LY80, p = .659 [0.0025], MMRM analysis). RIS statistically separated from placebo in both populations (p < .001 [0.05]). There were no statistically significant differences in the incidence of serious adverse events, and no seizures on LY2140023.
LY2140023 treatment did not demonstrate efficacy in populations studied. Overall, LY2140023 treatment was generally well tolerated with no new adverse safety findings compared to previous trials. Further understanding of the role of glutamate as a therapeutic target in schizophrenia is needed.
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR SchizophreniaClinicalTrials.gov identifier: NCT01086748.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>25539791</pmid><doi>10.1186/s12888-014-0351-3</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Amino Acids - administration & dosage Analysis Antipsychotic Agents - administration & dosage Dopamine Antagonists - administration & dosage Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Humans Hypotheses Male Medical research Methods Middle Aged Pharmaceutical industry Psychiatric Status Rating Scales Psychiatry Receptors, Metabotropic Glutamate - agonists Risperidone - administration & dosage Schizophrenia Schizophrenia - drug therapy Studies Treatment Outcome Young Adult |
| title | A Double-Blind, Placebo-Controlled Comparator Study of LY2140023 monohydrate in patients with schizophrenia |
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