Comparative study of the efficacy and safety between blonanserin and risperidone for the treatment of schizophrenia in Chinese patients: A double-blind, parallel-group multicenter randomized trial.
This randomized, double-blind study compared the efficacy and safety of blonanserin and risperidone to treat Chinese schizophrenia patients aged ≥18 and < 65 years. Patients with Positive and Negative Syndrome Scale (PANSS) total scores ≥70 and ≤ 120 were randomized to receive blonanserin or risperidone using a gradual dose-titration method (blonanserin tablets: 8-24 mg/day; risperidone tablets: 2-6 mg/day), twice daily. Treatment populations consisted of 128 blonanserin-treated patients and 133 risperidone-treated patients. Intention-to-treat analysis was performed using the last observation carried forward method. Reductions of PANSS total scores by blonanserin and risperidone treatment were -30.59 and -33.56, respectively. Risperidone treatment was associated with elevated levels of serum prolactin (67.16% risperidone versus 52.31% blonanserin) and cardiac-related abnormalities (22.39% risperidone versus 12.31% blonanserin), and blonanserin patients were more prone to extrapyramidal side effects (48.46% blonanserin versus 29.10% risperidone). In conclusion, blonanserin was as effective as risperidone for the treatment of Chinese patients with schizophrenia. The overall safety profiles of these drugs are comparable, although blonanserin was associated with a higher incidence of EPS and risperidone was associated with a higher incidence of prolactin elevation and weight gain. Thus, blonanserin is useful for the treatment of Chinese schizophrenia patients.
Department of Psychiatry, Shanghai Mental Health Center, Shanghai, 200030, China. Electronic address: lhlh_5@163.com.
Huafang
H
Li
Peking University Clinical Research Institute, Beijing, 100191, China. Electronic address: yaoc301@qq.com.
Chen
C
Yao
Department of Psychiatry, Xi'an Mental Health Center, Xi'an, 710061, China. Electronic address: sjgysh@sohu.com.
Jianguo
J
Shi
Department of Psychiatry, Beijing Huilongguan Hospital, Beijing, 100096, China. Electronic address: yandf@126.com.
Fude
F
Yang
Department of Psychiatry, Wuxi Mental Health Center, Wuxi, 214000, China. Electronic address: shuguangqi0208@126.com.
Shuguang
S
Qi
Department of Psychiatry, Tianjin Anding Hospital, Tianjin, 300222, China. Electronic address: 13920084798@163.com.
Lili
L
Wang
Department of Psychiatry, Brains Hospital of Hunan Province, Changsha, 410007, China. Electronic address: gen571@126.com.
Honggeng
H
Zhang
Department of Psychiatry, Guangzhou Brain Hospital, Guangzhou, 510370, China. Electronic address: biglijie@163.com.
Jie
J
Li
Department of Psychiatry, Beijing Anding Hospital of Capital Medical University, Beijing, 100088, China. Electronic address: w.cy@163.net.
Chuanyue
C
Wang
Department of Psychiatry, Henan Provincial Mental Hospital, Xinxiang, 453002, China. Electronic address: chuansonwang@126.com.
Chuansheng
C
Wang
Department of Psychiatry, Sixth Hospital of Peking University, Beijing, 100191, China. Electronic address: liucui0723@hotmail.com.
Cui
C
Liu
Department of Psychiatry, Second Xiangya Hospital of Central South University, Changsha, 410000, China. Electronic address: llyyz2006@126.com.
Lehua
L
Li
Department of Psychiatry, West China Hospital of Sichuan University, Chengdu, 610041, China. Electronic address: wangqiang130@hotmail.com.
Qiang
Q
Wang
Department of Psychiatry, Hebei Mental Health Center, Baoding, 071000, China. Electronic address: like1002@sina.com.
Keqing
K
Li
Medical Division, Sumitomo Pharma(Suzhou) Co., Ltd. Beijing, 100007, China. Electronic address: luo@dsmpharm.com.cn.
Xiaoyan
X
Luo
Department of Psychiatry, Shanghai Mental Health Center, Shanghai, 200030, China. Electronic address: guniufan@outlook.com.
Niufan
N
Gu
D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D002681:China; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects; D011388:Prolactin / Q000097:blood; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects; D012559:Schizophrenia / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D012565:Schizophrenic Psychology; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects; D055815:Young Adult
D014150:Antipsychotic Agents; D010879:Piperazines; D010880:Piperidines; D011388:Prolactin; C079310:blonanserin; D018967:Risperidone
Antipsychotic agents; Blonanserin; Randomized controlled trial; Risperidone; Schizophrenia