Evidence map›Paper›PMID 35443947›Full record

ArticleBMJ open2022

Effectiveness and safety of blonanserin for improving social and cognitive functions in patients with first-episode schizophrenia: a study protocol for a prospective, multicentre, single-arm clinical trial.

Chengcheng Pu, Lei Lei, Fude Yang, Hong Deng, Jianhua Sheng, Zhening Liu, Shaohua Hu, Lina Wang, Bin Wu, Qijing Bo and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03784222 (Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT03784222 phase4terminatednot on this map

Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients

TypeinterventionalSponsorMarubeni Pharmaceuticals (Suzhou) Co., Ltd.Ran2019 to 2022Enrolled102ConditionsFirst Episode Schizophrenia, Social Function, Cognition Function, BlonanserinArmsBlonanserin, MRI and serum BDNF
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Observational
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Chengcheng PuDepartment of Clinical Research, Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.
Lei LeiMedical Department, Sumitomo Pharma (Suzhou) Co, Shanghai, China.
Fude YangPsychiatry Research Center, Beijing Huilongguan Hospital, Beijing, China.
Hong DengMental Health Center, West China Hospital of Sichuan University, Chengdu, China.
Jianhua ShengDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai, China.
Zhening LiuMental Health Institute, the Second Xiangya Hospital of Central South University, Changsha, China.
Shaohua HuDepartment of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Lina WangDepartment of Psychiatry and Imaging-Genetics and Co-morbidity (PNGC-Lab), Tianjin Anding Hospital, Tianjin, China.
Bin WuDepartment of Psychiatry, Xi'an Mental Health Center, Xi'an, China.
Qijing BoDepartment of Psychiatry, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Yoshifumi InoueMedical Affairs Department, Sumitomo Dainippon Pharma Co, Osaka, Japan.
Xin YuDepartment of Clinical Research, Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China yuxin@bjmu.edu.cn.ORCID 0000-0003-3983-4937

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBoth the pharmacological characteristics of blonanserin and its related small sample size studies suggest that blonanserin could alleviate social and cognitive dysfunctions in patients with schizophrenia. However, no large sample size studies have been performed so far. This study aimed to investigate the effectiveness and safety of blonanserin in improving social and cognitive functions in patients with first-episode schizophrenia. METHODS AND ANALYSIS: This is a prospective, multicentre, single-arm clinical trial. A total of 188 patients with first-episode schizophrenia will be enrolled and will undergo a 0-7 day washout period before blonanserin administration. Doses of blonanserin will first be set to 4 mg P.O. twice per day after meals and gradually increased to 8-16 mg/d P.O., depending on patient's age and symptoms, for 26 weeks. Maximum dose of blonanserin will not be exceeding 24 mg/day. The primary endpoint of the study is the changes of Personal and Social Performance (PSP) score in patients from baseline to week 26. Secondary endpoints include changes in MATRICS consensus cognitive battery (MCCB), Paced Auditory Serial Addition Test (PASAT), grooved pegboard test (GPT), Positive and Negative Syndrome Scale (PANSS) total score and PANSS 5-factor subscale scores. Other endpoints include changes of serum brain-derived neurotrophic factor (BDNF) at corresponding visits and MRI results. Moreover, incidence of adverse events, changes in endocrine and metabolic profiles, renal, hepatic and sexual functions and extrapyramidal symptoms will be strictly monitored and recorded. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the leading site Peking University Sixth Hospital (No. 2018-18), and all included patients are requested to provide written informed consent before enrolment. The study will be conducted according to the principles of the Declaration of Helsinki and follow the principles for clinical research. TRIAL REGISTRATION NUMBER: NCT03784222.

Indexed as

Antipsychotic AgentsPiperazinesPiperidinesSchizophreniaCognitionHumansMulticenter Studies as TopicProspective StudiesSchizophrenic PsychologySocial InteractionTreatment OutcomeAntipsychotic AgentsblonanserinPiperazinesPiperidinesAdult psychiatryPSYCHIATRYSchizophrenia & psychotic disorders

Identifiers

PMID35443947
PMCPMC9021809

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.