Blonanserin versus haloperidol in Japanese patients with schizophrenia: A phase 3, 8-week, double-blind, multicenter, randomized controlled study

Philip D Harvey, Hiroshi Nakamura, Mitsukuni Murasaki

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)173-182
Number of pages10
JournalNeuropsychopharmacology Reports
Volume39
Issue number3
DOIs
StatePublished - Sep 1 2019

Fingerprint

Haloperidol
Schizophrenia
blonanserin
Pharmaceutical Preparations
Prolactin
Hypotension
Weight Gain
Language
Pharmacology
Safety
Incidence
Therapeutics

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 journalArticle

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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.",
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