Evidence map›Paper›PMID 31471246›Full record

Trial reportSchizophrenia research2020

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

Nakao Iwata, Jun Ishigooka, Won-Hyoung Kim, Bo-Hyun Yoon, Shih-Ku Lin, Ahmad Hatim Sulaiman, Rowena Cosca, Lina Wang, Yury Suchkov, Alexey Agarkov and 7 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Schizophrenia research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 14 institutions in 9 countries.

Nakao IwataDepartment of Psychiatry, Fujita Health University, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan. Electronic address: nakao@fujita-hu.ac.jp.
Jun IshigookaInstitute of CNS Pharmacology, 4-26-11, Sendagaya, Shibuya-Ku, Tokyo 151-0051, Japan. Electronic address: ishigooka@i-cnsp.com.
Won-Hyoung KimDepartment of Psychiatry, Inha University Hospital, 27, Inhang-ro, Jung-gu Incheon, 22332, Republic of Korea.
Bo-Hyun YoonDepartment of Psychiatry, Naju National Hospital, 1328-31 Senam-ro, Sanpo-myeon, Naju-City, Jeonnam 58213, Republic of Korea. Electronic address: yoonbh@chollian.net.
Shih-Ku LinDepartment 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.
Ahmad Hatim SulaimanDepartment of Psychological Medicine, University Malaya Medical Centre, 50603 Kuala Lumpur, Malaysia. Electronic address: hatim@ummc.edu.my.
Rowena CoscaDepartment of Psychiatry, Western Visayas Medical Center, Q. Abeto St., Mandurriao, Iloilo City 5000, Philippines.
Lina WangDepartment of Mood Disorders, Tianjin Anding Hospital, Liulin Road 13, Hexi District, Tianjin 300222, China.
Yury SuchkovDepartments of Psychiatric Hospital, SBHI of Nizhny Novgorod Region "Clinical Psychiatric Hospital No. 1 of Nizhny Novgorod", 41 Ulianova St., Nizhny Novgorod 603155, Russia.
Alexey AgarkovResearch Center of Mental Health, Tomsk National Research Medical Center, Russian Academy of Sciences, 4 Aleutskaya St., Tomsk 634014, Russia.
Kei WatabeSumitomo Dainippon Pharma Co., Ltd., 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo 104-8356, Japan.
Tomohito MatsuiSumitomo Dainippon Pharma Co., Ltd., 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo 104-8356, Japan.
Takayuki SatoSumitomo Dainippon Pharma Co., Ltd., 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo 104-8356, Japan.
Yoshifumi InoueSumitomo Dainippon Pharma Co., Ltd., 13-1, Kyobashi 1-Chome, Chuo-ku, Tokyo 104-8356, Japan. Electronic address: yoshifumi-inoue@ds-pharma.co.jp.
Teruhiko HiguchiJapan Depression Center, 1-7, Rokubancho, Chiyoda-ku, Tokyo 102-0085, Japan.
Christoph U CorrellDepartment 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.
John M KaneDepartment 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.
Sumitomo Dainippon Pharma (Japan) · JPCharité - Universitätsmedizin Berlin · DEDonald & Barbara Zucker School of Medicine at Hofstra/Northwell · USFujita Health University Hospital · JPInha University Hospital · KRJapan Coal Energy Center · JPNaju National Hospital · KRNizhny Novgorod Research Institute of Traumatology and Orthopedics · RURussian Academy of Sciences · RUShibuya (Japan) · JPTaipei City Hospital · TWTianjin Anding Hospital · CNUniversity Malaya Medical Centre · MYUniversity of Iloilo · PH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBlonanserin 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.

methodsThis 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).

resultsBetween 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.

conclusionsBlonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability.

Indexed as

Outcome Assessment, Health CareAcute DiseaseAdultAntipsychotic AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedPiperazinesPiperidinesPsychiatric Status Rating ScalesSchizophreniaTransdermal PatchAntipsychotic AgentsblonanserinPiperazinesPiperidinesAdherenceAntipsychoticsDopamine D(3)-receptor

Identifiers

PMID31471246
OpenAlexW2971096622

What OpenQuestion holds

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Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.