Blonanserin vs risperidone in Japanese patients with schizophrenia: A post hoc analysis of a phase 3, 8-week, multicenter, double-blind, randomized controlled study

Neuropsychopharmacology Reports
Philip D HarveySadanori Miura

Abstract

To report the efficacy and safety of blonanserin in patients with schizophrenia compared with risperidone in a Japanese multicenter, randomized, double-blind study based on post hoc sensitivity analysis in addition to the previous results reported by Miura and discuss the current approaches for schizophrenia treatment. Of 302 patients randomized, 156 received blonanserin (8-24 mg/d) and 145 received risperidone (2-6 mg/d) for 8 weeks. Efficacy variables included the Positive and Negative Syndrome Scale (PANSS) total score for the primary outcome, PANSS subscale, Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impression-Improvement (CGI-I) for secondary outcomes. Safety variables included treatment-emergent adverse events, Drug Induced Extrapyramidal Symptoms Scale scores, laboratory data, vital signs, electrocardiogram, etc RESULTS: Blonanserin was not inferior to risperidone in the change in PANSS total score at a non-inferior margin of -7 (intergroup difference, -0.46; 95% CI, -4.40 to 3.48). Post hoc analyses wholly supported the primary result. No major difference was found in the changes in BPRS scores and the improvement rate on CGI-I between the drugs. The incidence of adverse events was similar in the two dr...Continue Reading

Citations

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Related Concepts

PRL
Schizophrenia
Clinical Global Impression Questionnaire
Emergency Treatment
Laboratory
Adverse Event
Multicenter Study
Orthostatic Hypotensive Disorder, Streeten Type
Akathisia, Drug-Induced
Pharmacologic Substance

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