Nakao Iwata1, Jun Ishigooka2, Won-Hyoung Kim3, Bo-Hyun Yoon4, Shih-Ku Lin5, Ahmad Hatim Sulaiman6, Rowena Cosca7, Lina Wang8, Yury Suchkov9, Alexey Agarkov10, Kei Watabe11, Tomohito Matsui11, Takayuki Sato11, Yoshifumi Inoue12, Teruhiko Higuchi13, Christoph U Correll14, John M Kane15. 1. Department of Psychiatry, Fujita Health University, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan. Electronic address: nakao@fujita-hu.ac.jp. 2. Institute of CNS Pharmacology, 4-26-11, Sendagaya, Shibuya-Ku, Tokyo 151-0051, Japan. Electronic address: ishigooka@i-cnsp.com. 3. Department of Psychiatry, Inha University Hospital, 27, Inhang-ro, Jung-gu Incheon, 22332, Republic of Korea. 4. Department of Psychiatry, Naju National Hospital, 1328-31 Senam-ro, Sanpo-myeon, Naju-City, Jeonnam 58213, Republic of Korea. Electronic address: yoonbh@chollian.net. 5. Department of Psychiatry, Taipei City Hospital and Psychiatric Center, No.309, Songde Rd., Xinyi Dist., Taipei City 110, Taiwan, ROC. Electronic address: DAF68@tpech.gov.tw. 6. Department of Psychological Medicine, University Malaya Medical Centre, 50603 Kuala Lumpur, Malaysia. Electronic address: hatim@ummc.edu.my. 7. Department of Psychiatry, Western Visayas Medical Center, Q. Abeto St., Mandurriao, Iloilo City 5000, Philippines. 8. Department of Mood Disorders, Tianjin Anding Hospital, Liulin Road 13, Hexi District, Tianjin 300222, China. 9. Departments of Psychiatric Hospital, SBHI of Nizhny Novgorod Region "Clinical Psychiatric Hospital No. 1 of Nizhny Novgorod", 41 Ulianova St., Nizhny Novgorod 603155, Russia. 10. Research Center of Mental Health, Tomsk National Research Medical Center, Russian Academy of Sciences, 4 Aleutskaya St., Tomsk 634014, Russia. 11. Sumitomo Dainippon Pharma Co., Ltd., 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo 104-8356, Japan. 12. Sumitomo Dainippon Pharma Co., Ltd., 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo 104-8356, Japan. Electronic address: yoshifumi-inoue@ds-pharma.co.jp. 13. Japan Depression Center, 1-7, Rokubancho, Chiyoda-ku, Tokyo 102-0085, Japan. 14. Department of Psychiatry, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, 75-59 263rd Street Glen Oaks, New York 11004, USA; Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, NY, USA; Department of Psychiatry, Hofstra Northwell School of Medicine, Hempstead, NY, USA; Department of Psychiatry, The Zucker Hillside Hospital, 75-59 263rd Street Glen Oaks, New York 11004, USA; Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany. 15. Department of Psychiatry, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, 75-59 263rd Street Glen Oaks, New York 11004, USA; Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, NY, USA; Department of Psychiatry, Hofstra Northwell School of Medicine, Hempstead, NY, USA; Department of Psychiatry, The Zucker Hillside Hospital, 75-59 263rd Street Glen Oaks, New York 11004, USA.
Abstract
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 < 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.
RCT Entities:
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 < 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.