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Efficacy and Tolerability of Blonanserin in the Patients With Schizophrenia: A Randomized, Double-blind, Risperidone-Compared Trial

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Author(s)
Jaewon YangWon-Myong BahkHyun-Sang ChoYang-Whan JeonDuk-In JonHee-Yeon JungChan-Hyung KimHee-Cheol KimYong-Ku KimYoung-Hoon KimJun-Soo KwonSang-Yeol LeeSeung-Hwan LeeJung-Seo YiBo-Hyun YoonSeung-Hyun Kim
Publication Year
2010
Abstract
Objectives: The objective of this study was to evaluate the efficacy and tolerability of blonanserin for the treatment of Korean patients with schizophrenia using a double-blind risperidone-compared design.



Methods: Patients aged 18 to 65 years with schizophrenia were randomly assigned to blonanserin or risperidone treatment for 8 weeks. The efficacy was assessed using the mean change in Positive and Negative Syndrome Scale score total scores from baseline to week 8. Safety assessments included monitoring of vital signs, a physical examination, laboratory tests, and adverse events.



Results: Of 206 randomly enrolled patients, 103 receiving blonanserin and 103 receiving risperidone were included in the analysis. In this study, noninferiority between blonanserin and risperidone was demonstrated. The mean change in the Positive and Negative Syndrome Scale total score at the final evaluation time point was -23.48 ± 19.73 for the blonanserin group and -25.40 ± 18.38 for the risperidone group. Adverse events, which occurred less frequently in the blonanserin than in the risperidone group, included dysarthria (P = 0.0288), dizziness (P = 0.0139), increased alanine aminotransferase and aspartate aminotransferase (P = 0.0095 and P = 0.0032, respectively), and increased level blood prolactin (P = 0.0012). On the other hand, the adverse events that occurred more frequently in the blonanserin than in the risperidone group was hand tremor (P = 0.0006).



Conclusions: Blonanserin was effective in the treatment of Korean patients with schizophrenia compared with risperidone and was more tolerable with a better safety profile, particularly with respect to prolactin elevation. These findings suggest that blonanserin is useful in the treatment of schizophrenia.
Department
Dept. of Psychiatry (정신건강의학)
Publisher
School of Medicine
Citation
Clinical Neuropharmacology, Vol.33(4) : 169-175, 2010
Type
Article
ISSN
0362-5664
URI
http://kumel.medlib.dsmc.or.kr/handle/2015.oak/35461
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