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

© 2019 The Authors Background: 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. Methods: 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). Results: 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 \u3c 0.001). Blonanserin was well tolerated; the most common TEAEs reported were application-site erythema and pruritus, akathisia, tremor, and insomnia. Conclusions: Blonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability

Double-Blind, Placebo-Controlled Study of Lurasidone Monotherapy for the Treatment of Bipolar I Depression

Aim:Previous studies conducted primarily in the USA and Europe have demonstrated the efficacy and safety of lurasidone 20-120 mg/day for the treatment of bipolar I depression. The aim of the current study was to evaluate the efficacy and safety of lurasidone monotherapy for the treatment of bipolar I depression among patients from diverse ethnic backgrounds, including those from Japan. Methods:Patients were randomly assigned to double‐blind treatment for 6 weeks with lurasidone, 20-60 mg/day (n = 184) or 80-120 mg/day (n = 169), or placebo (n = 172). The primary end‐point was change from baseline to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS). Results:Lurasidone treatment significantly reduced mean MADRS total scores from baseline to Week 6 for the 20-60‐mg/day group (−13.6; adjusted P = 0.007; effect size = 0.33), but not for the 80-120‐mg/day group (−12.6; adjusted P = 0.057; effect size = 0.22) compared with placebo (−10.6). Treatment with lurasidone 20-60 mg/day also improved MADRS response rates, functional impairment, and anxiety symptoms. The most common adverse events associated with lurasidone were akathisia and nausea. Lurasidone treatments were associated with minimal changes in weight, lipids, and measures of glycemic control. Conclusion: Monotherapy with once daily doses of lurasidone 20-60 mg, but not 80-120 mg, significantly reduced depressive symptoms and improved functioning in patients with bipolar I depression. Results overall were consistent with previous studies, suggesting that lurasidone 20-60 mg/day is effective and safe in diverse ethnic populations, including Japanese

ヨウリョクタイガタ フェレドキシン ノ コウゾウ カイセキ 2.8Å ブンカイノウ

Remarkable progress in the physical parameters of net-current free plasmas has been made in the Large Helical Device (LHD) since the last Fusion Energy Conference in Chengdu, 2006 (O.Motojima et al., Nucl. Fusion 47 (2007) S668). The beta value reached 5 % and a high beta state beyond 4.5% from the diamagnetic measurement has been maintained for longer than 100 times the energy confinement time. The density and temperature regimes also have been extended. The central density has exceeded 1.0 x 10^21 m^-3 due to the formation of an Internal Diffusion Barrier (IDB). The ion temperature has reached 6.8 keV at the density of 2 x 10^19m^-3, which is associated with the suppression of ion heat conduction loss. Although these parameters have been obtained in separated discharges, each fusion-reactor relevant parameter has elucidated the potential of net-current free heliotron plasmas. Diversified studies in recent LHD experiments are reviewed in this paper