Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies

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dc.citation.issue1]
dc.citation.volume82]
dc.contributor.authorBugarski-Kirola, Dragana
dc.contributor.authorBlaettler, Thomas
dc.contributor.authorArango, Celso
dc.contributor.authorFleischhacker, Wolfgang W.
dc.contributor.authorGaribaldi, George
dc.contributor.authorWang, Alice
dc.contributor.authorDixon, Mark
dc.contributor.authorBressan, Rodrigo A. [UNIFESP]
dc.contributor.authorNasrallah, Henry
dc.contributor.authorLawrie, Stephen
dc.contributor.authorNapieralski, Julie
dc.contributor.authorOchi-Lohmann, Tania
dc.contributor.authorReid, Carol
dc.contributor.authorMarder, Stephen R.
dc.coverageNew York
dc.date.accessioned2020-06-26T16:30:32Z
dc.date.available2020-06-26T16:30:32Z
dc.date.issued2017
dc.description.abstractBACKGROUND: There is currently no standard of care for treatment of negative symptoms of schizophrenia, although some previous results with glutamatergic agonists have been promising. METHODS: Three (SunLyte [WN25308], DayLyte [WN25309], and FlashLyte [NN25310]) phase III, multicenter, randomized, 24-week, double-blind, parallel-group, placebo-controlled studies evaluated the efficacy and safety of adjunctive bitopertin in stable patients with persistent predominant negative symptoms of schizophrenia treated with antipsychotics. SunLyte met the prespecified criteria for lack of efficacy and was declared futile. Key inclusion criteria were age >= 18 years, DSM-IV-TR diagnosis of schizophrenia, score >= 40 on the sum of the 14 Positive and Negative Syndrome Scale negative symptoms and disorganized thought factors, unaltered antipsychotic treatment, and clinical stability. Following a 4-week prospective stabilization period, patients were randomly assigned 1: 1: 1 to bitopertin (5 mg and 10 mg [DayLyte] and 10 mg and 20 mg [FlashLyte]) or placebo once daily for 24 weeks. The primary efficacy end point was mean change from baseline in Positive and Negative Syndrome Scale negative symptom factor score at week 24. RESULTS: The intent-to-treat population in DayLyte and FlashLyte included 605 and 594 patients, respectively. At week 24, mean change from baseline showed improvement in all treatment arms but no statistically significant separation from placebo in Positive and Negative Syndrome Scale negative symptom factor score and all other end points. Bitopertin was well tolerated. CONCLUSIONS: These studies provide no evidence for superior efficacy of adjunctive bitopertin in any of the doses tested over placebo in patients with persistent predominant negative symptoms of schizophrenia.en
dc.description.affiliationF Hoffmann La Roche, Global Dev Team, Basel, Switzerland
dc.description.affiliation[Blaettler, Thomas
dc.description.affiliationF Hoffmann La Roche, Neurosci, Basel, Switzerland
dc.description.affiliationF Hoffmann La Roche, Neurosci Prod Dev, Basel, Switzerland
dc.description.affiliationF Hoffmann La Roche, Basel, Switzerland
dc.description.affiliationUniv Complutense, Ctr Invest Red Salud Mental CIBERSAM, Inst Invest Sanitaria Gregorio Maranon,Sch Med, Hosp Gen Univ Gregorio Maranon,Dept Psychiat, Madrid, Spain
dc.description.affiliationMed Univ Innsbruck, Dept Psychiat & Psychotherapy, Innsbruck, Austria
dc.description.affiliationRoche China Holding Ltd, Shanghai, Peoples R China
dc.description.affiliationRoche Prod Ltd, Welwyn Garden City, Herts, England
dc.description.affiliationUniv Fed Sao Paulo, Dept Psychiat, Sao Paulo, Brazil
dc.description.affiliationSt Louis Univ, Sch Med, Dept Psychiat & Behav Neurosci, St Louis, MO USA
dc.description.affiliationUniv Edinburgh, Dept Psychiat & Neuroimaging, Div Psychiat, Edinburgh, Midlothian, Scotland
dc.description.affiliationUniv Calif Los Angeles, Semel Inst Neurosci & Human Behav, Desert Pacific Mental Illness Res Educ & Clin Ctr, Los Angeles, CA 90024 USA
dc.description.affiliationUnifespUniv Fed Sao Paulo, Dept Psychiat, Sao Paulo, Brazil
dc.description.provenanceMade available in DSpace on 2020-06-26T16:30:32Z (GMT). No. of bitstreams: 0 Previous issue date: 2017en
dc.description.sourceWeb of Science
dc.description.sponsorshipF. Hoffmann-La Roche Ltd.
dc.description.sponsorshipAbbot
dc.description.sponsorshipAmgen
dc.description.sponsorshipAstraZeneca
dc.description.sponsorshipBristol-Myers Squibb
dc.description.sponsorshipCaja Navarra
dc.description.sponsorshipCIBERSAM Fundacion Alicia Koplowitz
dc.description.sponsorshipInstituto de Salud Carlos III
dc.description.sponsorshipJanssen Cilag
dc.description.sponsorshipLundbeck
dc.description.sponsorshipMerck
dc.description.sponsorshipMinisterio de Ciencia e Innovacion
dc.description.sponsorshipMinisterio de Sanidad
dc.description.sponsorshipMinisterio de Economia y Competitividad
dc.description.sponsorshipMutua Madrilena
dc.description.sponsorshipOtsuka
dc.description.sponsorshipPfizer
dc.description.sponsorshipRoche
dc.description.sponsorshipServier
dc.description.sponsorshipShire
dc.description.sponsorshipSchering-Plough
dc.description.sponsorshipSunovion
dc.description.sponsorshipTakeda
dc.description.sponsorshipJanssen
dc.description.sponsorshipNovartis
dc.description.sponsorshipCoordenacao de Aperfeicoamento de Pessoal de Nivel Superior [CAPES]
dc.description.sponsorshipNational Research Council [CNPq]
dc.description.sponsorshipFundacao de Amparo a Pesquisa do Estado de Sao Paulo [FAPESP]
dc.description.sponsorshipForum
dc.description.sponsorshipGenentech
dc.description.sponsorshipAbbvie
dc.description.sponsorshipBoehringer-Ingelheim
dc.description.sponsorshipPsychogenics
dc.description.sponsorshipIDF. Hoffmann-La Roche Ltd.
dc.description.sponsorshipIDAbbot
dc.description.sponsorshipIDAmgen
dc.description.sponsorshipIDAstraZeneca
dc.description.sponsorshipIDBristol-Myers Squibb
dc.description.sponsorshipIDCaja Navarra
dc.description.sponsorshipIDCIBERSAM Fundacion Alicia Koplowitz
dc.description.sponsorshipIDInstituto de Salud Carlos III
dc.description.sponsorshipIDJanssen Cilag
dc.description.sponsorshipIDLundbeck
dc.description.sponsorshipIDMerck
dc.description.sponsorshipIDMinisterio de Ciencia e Innovacion
dc.description.sponsorshipIDMinisterio de Sanidad
dc.description.sponsorshipIDMinisterio de Economia y Competitividad
dc.description.sponsorshipIDMutua Madrilena
dc.description.sponsorshipIDOtsuka
dc.description.sponsorshipIDPfizer
dc.description.sponsorshipIDRoche
dc.description.sponsorshipIDServier
dc.description.sponsorshipIDShire
dc.description.sponsorshipIDSchering-Plough
dc.description.sponsorshipIDSunovion
dc.description.sponsorshipIDTakeda
dc.description.sponsorshipIDJanssen
dc.description.sponsorshipIDNovartis
dc.description.sponsorshipIDCAPES
dc.description.sponsorshipIDCNPq
dc.description.sponsorshipIDFAPESP
dc.description.sponsorshipIDForum
dc.description.sponsorshipIDGenentech
dc.description.sponsorshipIDAbbvie
dc.description.sponsorshipIDBoehringer-Ingelheim
dc.description.sponsorshipIDPsychogenics
dc.format.extent8-16
dc.identifierhttp://dx.doi.org/10.1016/j.biopsych.2016.11.014]
dc.identifier.citationBiological Psychiatry. New York, v. 82, n. 1, p. 8-16, 2017.
dc.identifier.doi10.1016/j.biopsych.2016.11.014
dc.identifier.issn0006-3223
dc.identifier.urihttps://repositorio.unifesp.br/handle/11600/53603
dc.identifier.wosWOS:000403203900006
dc.language.isoeng
dc.publisherElsevier Science Inc
dc.relation.ispartofBiological Psychiatry
dc.rightsACESSO RESTRITO
dc.subjectAdjunctiveen
dc.subjectBitopertinen
dc.subjectGlycine reuptake inhibitoren
dc.subjectGRIen
dc.subjectNegative symptomsen
dc.subjectNMDA receptoren
dc.subjectSchizophreniaen
dc.titleBitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studiesen
dc.typeArtigo
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