%0 Journal Article %1 RN19 %A Bugarski-Kirola, Dragana %A Blaettler, Thomas %A Arango, Celso %A Fleischhacker, Wolfgang W. %A Garibaldi, George %A Wang, Alice %A Dixon, Mark %A Bressan, Rodrigo A. %A Nasrallah, Henry %A Lawrie, Stephen %A Napieralski, Julie %A Ochi-Lohmann, Tania %A Reid, Carol %A Marder, Stephen R. %D 2017 %J Biological Psychiatry %K imported public %N 1 %P 8-16 %R 10.1016/j.biopsych.2016.11.014 %T Bitopertin in Negative Symptoms of Schizophrenia—Results From the Phase III FlashLyte and DayLyte Studies %V 82 %X BackgroundThere is currently no standard of care for treatment of negative symptoms of schizophrenia, although some previous results with glutamatergic agonists have been promising. MethodsThree (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. ResultsThe 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. ConclusionsThese 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.

@article{RN19, abstract = {BackgroundThere is currently no standard of care for treatment of negative symptoms of schizophrenia, although some previous results with glutamatergic agonists have been promising. MethodsThree (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. ResultsThe 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. ConclusionsThese 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.}, added-at = {2017-10-14T21:46:53.000+0200}, author = {Bugarski-Kirola, Dragana and Blaettler, Thomas and Arango, Celso and Fleischhacker, Wolfgang W. and Garibaldi, George and Wang, Alice and Dixon, Mark and Bressan, Rodrigo A. and Nasrallah, Henry and Lawrie, Stephen and Napieralski, Julie and Ochi-Lohmann, Tania and Reid, Carol and Marder, Stephen R.}, biburl = {https://www.bibsonomy.org/bibtex/233762eca9096131209a6e2dd8fe6e195/tngominh}, doi = {10.1016/j.biopsych.2016.11.014}, interhash = {5cd30d3ebbb7b8e1439b7670c8073a89}, intrahash = {33762eca9096131209a6e2dd8fe6e195}, issn = {0006-3223}, journal = {Biological Psychiatry}, keywords = {imported public}, number = 1, pages = {8-16}, timestamp = {2017-10-15T05:59:36.000+0200}, title = {Bitopertin in Negative Symptoms of Schizophrenia—Results From the Phase III FlashLyte and DayLyte Studies}, type = {Journal Article}, volume = 82, year = 2017 }