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

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

Author Bugarski-Kirola, Dragana Google Scholar
Blaettler, Thomas Google Scholar
Arango, Celso Google Scholar
Fleischhacker, Wolfgang W. Google Scholar
Garibaldi, George Google Scholar
Wang, Alice Google Scholar
Dixon, Mark Google Scholar
Bressan, Rodrigo A. Autor UNIFESP Google Scholar
Nasrallah, Henry Google Scholar
Lawrie, Stephen Google Scholar
Napieralski, Julie Google Scholar
Ochi-Lohmann, Tania Google Scholar
Reid, Carol Google Scholar
Marder, Stephen R. Google Scholar
Abstract BACKGROUND: 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.
Keywords Adjunctive
Bitopertin
Glycine reuptake inhibitor
GRI
Negative symptoms
NMDA receptor
Schizophrenia
xmlui.dri2xhtml.METS-1.0.item-coverage New York
Language English
Sponsor F. Hoffmann-La Roche Ltd.
Abbot
Amgen
AstraZeneca
Bristol-Myers Squibb
Caja Navarra
CIBERSAM Fundacion Alicia Koplowitz
Instituto de Salud Carlos III
Janssen Cilag
Lundbeck
Merck
Ministerio de Ciencia e Innovacion
Ministerio de Sanidad
Ministerio de Economia y Competitividad
Mutua Madrilena
Otsuka
Pfizer
Roche
Servier
Shire
Schering-Plough
Sunovion
Takeda
Janssen
Novartis
Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior [CAPES]
National Research Council [CNPq]
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo [FAPESP]
Forum
Genentech
Abbvie
Boehringer-Ingelheim
Psychogenics
Grant number F. Hoffmann-La Roche Ltd.
Abbot
Amgen
AstraZeneca
Bristol-Myers Squibb
Caja Navarra
CIBERSAM Fundacion Alicia Koplowitz
Instituto de Salud Carlos III
Janssen Cilag
Lundbeck
Merck
Ministerio de Ciencia e Innovacion
Ministerio de Sanidad
Ministerio de Economia y Competitividad
Mutua Madrilena
Otsuka
Pfizer
Roche
Servier
Shire
Schering-Plough
Sunovion
Takeda
Janssen
Novartis
CAPES
CNPq
FAPESP
Forum
Genentech
Abbvie
Boehringer-Ingelheim
Psychogenics
Date 2017
Published in Biological Psychiatry. New York, v. 82, n. 1, p. 8-16, 2017.
ISSN 0006-3223 (Sherpa/Romeo, impact factor)
Publisher Elsevier Science Inc
Extent 8-16
Origin http://dx.doi.org/10.1016/j.biopsych.2016.11.014
Access rights ACESSO RESTRITO
Type Article
Web of Science ID WOS:000403203900006
URI https://repositorio.unifesp.br/handle/11600/53603

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