Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study

Schizophrenia Research
Nakao IwataJohn M Kane

Abstract

Blonanserin is a second-generation antipsychotic used for the treatment of schizophrenia. This study determined the efficacy, safety and pharmacokinetics of a blonanserin transdermal patch in patients with acutely exacerbated schizophrenia. This double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs). Between December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190); of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean [LSM] difference vs placebo: -5.6 with blonanserin 40 mg; 95% confidence interval [CI] -9.6, -1.6; adjusted p = 0.007, and - 10.4 with blonanserin 80 mg; 95% CI -14.4, -6.4; adjusted p < 0.001). Bl...Continue Reading

Related Concepts

Double-Blind Method
Emergency Treatment
Drug Kinetics
Randomization
Schizophrenia
Antipsychotic Agents
Evaluation
Phase 3 Clinical Trials
Blonanserin
Acute Schizophrenia

Related Feeds

Antipsychotic Drugs

Antipsychotic drugs are a class of medication primarily used to manage psychosis (including delusions, hallucinations, paranoia or disordered thought), principally in schizophrenia and bipolar disorder. Discover the latest research on antipsychotic drugs here

Related Papers

Asia-Pacific Psychiatry : Official Journal of the Pacific Rim College of Psychiatrists
Sakae TakahashiMakoto Uchiyama
Schizophrenia Research
Chittaranjan AndradeBheemsain Tekkalaki
Asia-Pacific Psychiatry : Official Journal of the Pacific Rim College of Psychiatrists
Taro KishiNakao Iwata
© 2021 Meta ULC. All rights reserved