Efficacy and tolerability of Blonanserin in the patients with schizophrenia: a randomized, double-blind, risperidone-compared trial.
OBJECTIVE
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.
Yang
Jaewon
J
Department of Psychiatry, Korea University Guro Hospital, Guro-Dong, Guro-Gu, Seoul 152-703, South Korea.
Bahk
Won-Myong
WM
Cho
Hyun-Sang
HS
Jeon
Yang-Whan
YW
Jon
Duk-In
DI
Jung
Hee-Yeon
HY
Kim
Chan-Hyung
CH
Kim
Hee-Cheol
HC
Kim
Yong-Ku
YK
Kim
Young-Hoon
YH
Kwon
Jun-Soo
JS
Lee
Sang-Yeol
SY
Lee
Seung-Hwan
SH
Yi
Jung-Seo
JS
Yoon
Bo-Hyun
BH
Kim
Seung-Hyun
SH
D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006966:Hyperprolactinemia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use*; D010880:Piperidines / Q000009:adverse effects* / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D015430:Weight Gain / Q000187:drug effects; D055815:Young Adult
D014150:Antipsychotic Agents; D010879:Piperazines; D010880:Piperidines; C079310:blonanserin; D018967:Risperidone