https://m2.mtmt.hu/ hun 2026-05-01 17:59 JournalArticle 3194039 VALIDATED true Export Date: 26 April 2025; Cited By: 271; CODEN: LANCA 0 2018-10-02T08:54:25.000+0000 false 3194039 2026-03-11T08:35:32.610+0000 2025-02-10T14:13:50.259+0000 2017-03-01T09:32:09.000+0000 true 10020178 Czobor Pál /api/author/10020178 Author true 10020178 2025-04-26T17:57:36.654+0000 2025-02-10T14:13:50.552+0000 true 10062062 Gere Tamásné /api/admin/10062062 Admin true 10062062 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Németh, G Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial true true /api/journal/3012 REVIEWED true false 3012 false 3012 true 0140-6736 1474-547X Journal FOREIGN 389 10074 1103 1113 1103 11 2017 BACKGROUND: Although predominant negative symptoms of schizophrenia can be severe enough to cause persistent impairment, effective treatment options are lacking. We aimed to assess the new generation antipsychotic cariprazine in adult patients with predominant negative symptoms. METHODS: In this randomised, double-blind, phase 3b trial, we enrolled adults aged 18-65 years with long-term (>2 year), stable schizophrenia and predominant negative symptoms (>6 months) at 66 study centres (mainly hospitals and university clinics, with a small number of private practices) in 11 European countries. Patients were randomly assigned (1:1) by an interactive web response system to 26 weeks of monotherapy with fixed-dose oral cariprazine (3 mg, 4.5 mg [target dose], or 6 mg per day) or risperidone (3 mg, 4 mg [target dose], or 6 mg per day); previous medication was discontinued over 2 weeks. The primary outcome was change from baseline to week 26 or end of treatment on the Positive and Negative Syndrome Scale factor score for negative symptoms (PANSS-FSNS) analysed in a modified intention-to-treat population of patients who had follow-up assessments within 5 days after last receipt of study drugs with a mixed-effects model for repeated measures. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with EudraCT, number 2012-005485-36. FINDINGS: Between May 27, 2013, and Nov 17, 2014, 533 patients were screened and 461 (86%) patients were randomised to treatment (230 for cariprazine and 231 for risperidone); 460 were included in the safety population (one patient discontinued before study drug intake). 227 (99%) of 230 patients in the cariprazine group and 229 (99%) of 230 patients in the risperidone group were included in the modified intention-to-treat population (178 [77%] in each group completed 26 weeks of treatment). Mean daily doses were 4.2 mg (SD 0.6) for cariprazine and 3.8 mg (0.4) for risperidone. Treatment-emergent adverse events (eg, insomnia, akathisia, worsening of schizophrenia, headache, anxiety) were reported in 123 (54%) patients treated with cariprazine and 131 (57%) patients treated with risperidone. Use of cariprazine led to a greater least squares mean change in PANSS-FSNS from baseline to week 26 than did risperidone (-8.90 points for cariprazine vs -7.44 points for risperidone; least squares mean difference -1.46, 95% CI -2.39 to -0.53; p=0.0022; effect size 0.31). One patient in the risperidone group died of a cause regarded as unrelated to treatment. INTERPRETATION: Our results support the efficacy of cariprazine in the treatment of predominant negative symptoms of schizophrenia. 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0 27 26 27 26 2024 0 31 28 31 28 2025 0 26 23 26 23 D1 A nemzetközi false 10020178,10005190,10035947 false false false 2018-01-23T08:05:48.000+0000 2017-03-01T09:35:29.000+0000 Pszichiátriai és Pszichoterápiás Klinika (SE / AOK / K); Richter Gedeon Nyrt. 6 9 2 12 0 true Language 10002 /api/language/10002 Angol English true 2 true PersonAuthorship 8900115 /api/authorship/8900115 1 0.083 true false true Author 10035947 /api/author/10035947 Németh György true 10035947 true Németh G true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false 25686966 true PersonAuthorship 8900116 /api/authorship/8900116 2 0.083 false false Author 10089886 /api/author/10089886 Laszlovszky István true true Laszlovszky I true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false 25686965 true PersonAuthorship 8900117 /api/authorship/8900117 3 0.083333336 false false Author 10020178 /api/author/10020178 Czobor Pál true 10020178 true Czobor P true false false AuthorshipType 1 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1 /api/authorshiptype/1 0 true 0 true false 25686959 true PersonAuthorship 8900123 /api/authorship/8900123 9 0.083333336 false false Durgam S true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false 25686958 true PersonAuthorship 8900124 /api/authorship/8900124 10 0.083333336 false false Author 10005190 /api/author/10005190 Bitter István true 10005190 true Bitter I true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false 25686957 true PersonAuthorship 8900125 /api/authorship/8900125 11 0.083333336 false false Marder S true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false 25686956 true PersonAuthorship 8900126 /api/authorship/8900126 12 0.083333336 false true Fleischhacker WW true false false AuthorshipType 1 /api/authorshiptype/1 0 true 0 true false 25686955 true PublicationIdentifier 1180878 /api/publicationidentifier/1180878 PlainSource 6 /api/publicationsource/6 PublicationSourceType 10001 /api/publicationsourcetype/10001 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RatingType 10011 /api/ratingtype/10011 DEM Institute 19060 /api/institute/19060 0 false true false Demográfiai Osztályközi Állandó Bizottság Committee on Demography true 19060 true true true A nemzetközi false true MtaRating 519059 /api/mtarating/519059 RatingType 10007 /api/ratingtype/10007 SZTB Institute 14102 /api/institute/14102 0 false true false Szociológiai Tudományos Bizottság Committee on Sociology true 14102 true true true A nemzetközi true 19059 true SjrRating 10971853 /api/sjrrating/10971853 7 0.0 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2701 /api/classificationexternal/2701 true 2701 true D1 DIRECT true true /api/publication/3194039 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" mtid="10035947"><a href="/gui2/?type=authors&mode=browse&sel=10035947" target="_blank">Németh G ✉ (<span class="authorship-author-name">Németh György</span> <span class="authorAux-mtmt"> Neurológia</span>) </a> </span> <span class="author-affil">Richter Gedeon Nyrt.</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10089886"><a href="/gui2/?type=authors&mode=browse&sel=10089886" target="_blank">Laszlovszky I (<span class="authorship-author-name">Laszlovszky István</span> <span class="authorAux-mtmt"> klinikai kutatás, neurokémia, farmakológia</span>) </a> </span> <span class="author-affil">Richter Gedeon Nyrt.</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10020178"><a href="/gui2/?type=authors&mode=browse&sel=10020178" target="_blank">Czobor P (<span class="authorship-author-name">Czobor Pál</span> <span class="authorAux-mtmt"> Pszichiátria</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Pszichiátriai és Pszichoterápiás Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Szalai E </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10048351"><a href="/gui2/?type=authors&mode=browse&sel=10048351" target="_blank">Szatmári B (<span class="authorship-author-name">Szatmári Balázs</span> <span class="authorAux-mtmt"> Neurológia</span>) </a> </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Harsányi J </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10092649"><a href="/gui2/?type=authors&mode=browse&sel=10092649" target="_blank">Barabássy Á (<span class="authorship-author-name">Barabássy Ágota</span> <span class="authorAux-mtmt"> CNS</span>) </a> </span> <span class="author-affil">Richter Gedeon Nyrt.</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Debelle M </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Durgam S </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10005190"><a href="/gui2/?type=authors&mode=browse&sel=10005190" target="_blank">Bitter I (<span class="authorship-author-name">Bitter István</span> <span class="authorAux-mtmt"> Elmekórtan</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Pszichiátriai és Pszichoterápiás Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Marder S </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Fleischhacker WW </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;3194039" target="_blank">Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial</a></div> <div> <span class="journal-title">LANCET</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0140-6736">0140-6736</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1474-547X">1474-547X</a>)</span>: <span class="journal-volume">389</span> <span class="journal-issue">10074</span> <span class="page"> pp 1103-1113 </span> <span class="year">(2017)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_PAY" title=" Fizetős "> <a style="color:blue" title="10.1016/S0140-6736(17)30060-0" target="_blank" href="https://doi.org/10.1016/S0140-6736%2817%2930060-0"> DOI </a> </span> <span class="id identifier oa_CLOSED" title=" Zárt "> <a style="color:blue" title="4143" target="_blank" href="https://repo.lib.semmelweis.hu/handle/123456789/4143"> SE Repozitórium </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000396408700026" target="_blank" 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<div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 279</span> | Független: 241 | Függő: 38 | Nem jelölt: 0 | WoS jelölt: 243 | Scopus jelölt:&nbsp;231 | WoS/Scopus jelölt:&nbsp;279 | DOI jelölt:&nbsp;257 (Nem nyilvános:&nbsp;3) </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;3194039&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 10 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 3194039</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> <span class="oldId">Régi azonosító: 3194039</span> | Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">MEDLINE</span> </div> <div class="lastModified">Utolsó módosítás: 2025.02.10. 15:13 Gere Tamásné (SE_KK_Admin5_GT, admin) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Export Date: 26 April 2025; Cited By: 271; CODEN: LANCA</pre> </div></div>