title: Efficacy and tolerability of Blonanserin in the patients with schizophrenia: a randomized, double-blind, risperidone-compared trial.
abstract: 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.
authors.affiliation: Department of Psychiatry, Korea University Guro Hospital, Guro-Dong, Guro-Gu, Seoul 152-703, South Korea.
authors.forename: Jaewon
authors.initials: J
authors.lastname: Yang
authors.forename: Won-Myong
authors.initials: WM
authors.lastname: Bahk
authors.forename: Hyun-Sang
authors.initials: HS
authors.lastname: Cho
authors.forename: Yang-Whan
authors.initials: YW
authors.lastname: Jeon
authors.forename: Duk-In
authors.initials: DI
authors.lastname: Jon
authors.forename: Hee-Yeon
authors.initials: HY
authors.lastname: Jung
authors.forename: Chan-Hyung
authors.initials: CH
authors.lastname: Kim
authors.forename: Hee-Cheol
authors.initials: HC
authors.lastname: Kim
authors.forename: Yong-Ku
authors.initials: YK
authors.lastname: Kim
authors.forename: Young-Hoon
authors.initials: YH
authors.lastname: Kim
authors.forename: Jun-Soo
authors.initials: JS
authors.lastname: Kwon
authors.forename: Sang-Yeol
authors.initials: SY
authors.lastname: Lee
authors.forename: Seung-Hwan
authors.initials: SH
authors.lastname: Lee
authors.forename: Jung-Seo
authors.initials: JS
authors.lastname: Yi
authors.forename: Bo-Hyun
authors.initials: BH
authors.lastname: Yoon
authors.forename: Seung-Hyun
authors.initials: SH
authors.lastname: Kim
mesh_terms: 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
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D010880:Piperidines; C079310:blonanserin; D018967:Risperidone