Abstract
Objective: This Japanese, multicenter, randomized, double-blind trial, evaluating the efficacy and safety of blonanserin compared with haloperidol in patients with schizophrenia, was previously published by Murasaki in the Japanese language. In this article, we present the results of the trial based on full analysis dataset instead of per protocol dataset formerly reported and discuss the findings in light of the latest knowledge of pharmacological treatment for schizophrenia. Methods: A total of 265 patients were randomized to receive blonanserin (8 to 24 mg/d) or haloperidol (4 to 12 mg/d) twice daily for 8 weeks. Efficacy assessments included the Clinical Global Impressions—Improvement (CGI-I) and the Positive and Negative Syndrome Scale (PANSS). Results: Blonanserin was not inferior to haloperidol with a margin of 10% with respect to the improvement rate on CGI-I at end of study (60.5% vs 50.0%, P < 0.001). The decrease in the PANSS total score did not differ between the drugs (−10.3 vs −7.1). For the PANSS negative symptom score, the decrease was significantly greater with blonanserin than with haloperidol (P = 0.006). Blonanserin was well tolerated. The incidence of adverse events was similar for the two drugs. Extrapyramidal adverse events, sedation, hypotension, and prolactin increase were rarer with blonanserin than with haloperidol. No clinically important weight gain was observed. Conclusions: Blonanserin is as effective as haloperidol for the treatment of schizophrenia. Blonanserin is more effective for negative symptoms with a lower risk of extrapyramidal symptoms compared with haloperidol.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 173-182 |
| Number of pages | 10 |
| Journal | Neuropsychopharmacology Reports |
| Volume | 39 |
| Issue number | 3 |
| DOIs | |
| State | Published - Sep 1 2019 |
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Keywords
- antipsychotic agents
- blonanserin
- haloperidol
- randomized controlled trial
- schizophrenia
ASJC Scopus subject areas
- Clinical Psychology
- Pharmacology
- Psychiatry and Mental health
- Pharmacology (medical)
Cite this
Blonanserin versus haloperidol in Japanese patients with schizophrenia : A phase 3, 8-week, double-blind, multicenter, randomized controlled study. / Harvey, Philip D; Nakamura, Hiroshi; Murasaki, Mitsukuni.
In: Neuropsychopharmacology Reports, Vol. 39, No. 3, 01.09.2019, p. 173-182.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Blonanserin versus haloperidol in Japanese patients with schizophrenia
T2 - A phase 3, 8-week, double-blind, multicenter, randomized controlled study
AU - Harvey, Philip D
AU - Nakamura, Hiroshi
AU - Murasaki, Mitsukuni
PY - 2019/9/1
Y1 - 2019/9/1
N2 - Objective: This Japanese, multicenter, randomized, double-blind trial, evaluating the efficacy and safety of blonanserin compared with haloperidol in patients with schizophrenia, was previously published by Murasaki in the Japanese language. In this article, we present the results of the trial based on full analysis dataset instead of per protocol dataset formerly reported and discuss the findings in light of the latest knowledge of pharmacological treatment for schizophrenia. Methods: A total of 265 patients were randomized to receive blonanserin (8 to 24 mg/d) or haloperidol (4 to 12 mg/d) twice daily for 8 weeks. Efficacy assessments included the Clinical Global Impressions—Improvement (CGI-I) and the Positive and Negative Syndrome Scale (PANSS). Results: Blonanserin was not inferior to haloperidol with a margin of 10% with respect to the improvement rate on CGI-I at end of study (60.5% vs 50.0%, P < 0.001). The decrease in the PANSS total score did not differ between the drugs (−10.3 vs −7.1). For the PANSS negative symptom score, the decrease was significantly greater with blonanserin than with haloperidol (P = 0.006). Blonanserin was well tolerated. The incidence of adverse events was similar for the two drugs. Extrapyramidal adverse events, sedation, hypotension, and prolactin increase were rarer with blonanserin than with haloperidol. No clinically important weight gain was observed. Conclusions: Blonanserin is as effective as haloperidol for the treatment of schizophrenia. Blonanserin is more effective for negative symptoms with a lower risk of extrapyramidal symptoms compared with haloperidol.
AB - Objective: This Japanese, multicenter, randomized, double-blind trial, evaluating the efficacy and safety of blonanserin compared with haloperidol in patients with schizophrenia, was previously published by Murasaki in the Japanese language. In this article, we present the results of the trial based on full analysis dataset instead of per protocol dataset formerly reported and discuss the findings in light of the latest knowledge of pharmacological treatment for schizophrenia. Methods: A total of 265 patients were randomized to receive blonanserin (8 to 24 mg/d) or haloperidol (4 to 12 mg/d) twice daily for 8 weeks. Efficacy assessments included the Clinical Global Impressions—Improvement (CGI-I) and the Positive and Negative Syndrome Scale (PANSS). Results: Blonanserin was not inferior to haloperidol with a margin of 10% with respect to the improvement rate on CGI-I at end of study (60.5% vs 50.0%, P < 0.001). The decrease in the PANSS total score did not differ between the drugs (−10.3 vs −7.1). For the PANSS negative symptom score, the decrease was significantly greater with blonanserin than with haloperidol (P = 0.006). Blonanserin was well tolerated. The incidence of adverse events was similar for the two drugs. Extrapyramidal adverse events, sedation, hypotension, and prolactin increase were rarer with blonanserin than with haloperidol. No clinically important weight gain was observed. Conclusions: Blonanserin is as effective as haloperidol for the treatment of schizophrenia. Blonanserin is more effective for negative symptoms with a lower risk of extrapyramidal symptoms compared with haloperidol.
KW - antipsychotic agents
KW - blonanserin
KW - haloperidol
KW - randomized controlled trial
KW - schizophrenia
UR - http://www.scopus.com/inward/record.url?scp=85071299542&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071299542&partnerID=8YFLogxK
U2 - 10.1002/npr2.12057
DO - 10.1002/npr2.12057
M3 - Article
C2 - 31041855
AN - SCOPUS:85071299542
VL - 39
SP - 173
EP - 182
JO - Neuropsychopharmacology Reports
JF - Neuropsychopharmacology Reports
SN - 1340-2544
IS - 3
ER -