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 Article Swipe
Chengcheng Pu
,
Lei Lei
,
Fude Yang
,
Hong Deng
,
Jianhua Sheng
,
Zhening Liu
,
Shaohua Hu
,
Lina Wang
,
Bin Wu
,
Qijing Bo
,
Yoshifumi Inoue
,
Xin Yu
·
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2021-054079
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2021-054079
Introduction Both 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 .
Related Topics
Concepts
Medicine
Positive and Negative Syndrome Scale
Schizophrenia (object-oriented programming)
Clinical trial
Clinical endpoint
Psychiatry
Clinical Global Impression
Adverse effect
Extrapyramidal symptoms
Internal medicine
Prospective cohort study
Psychosis
Antipsychotic
Placebo
Pathology
Alternative medicine
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2021-054079
- https://bmjopen.bmj.com/content/bmjopen/12/4/e054079.full.pdf
- OA Status
- gold
- Cited By
- 3
- References
- 21
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4224283591
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4224283591Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1136/bmjopen-2021-054079Digital Object Identifier
- Title
-
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 trialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2022Year of publication
- Publication date
-
2022-04-01Full publication date if available
- Authors
-
Chengcheng Pu, Lei Lei, Fude Yang, Hong Deng, Jianhua Sheng, Zhening Liu, Shaohua Hu, Lina Wang, Bin Wu, Qijing Bo, Yoshifumi Inoue, Xin YuList of authors in order
- Landing page
-
https://doi.org/10.1136/bmjopen-2021-054079Publisher landing page
- PDF URL
-
https://bmjopen.bmj.com/content/bmjopen/12/4/e054079.full.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://bmjopen.bmj.com/content/bmjopen/12/4/e054079.full.pdfDirect OA link when available
- Concepts
-
Medicine, Positive and Negative Syndrome Scale, Schizophrenia (object-oriented programming), Clinical trial, Clinical endpoint, Psychiatry, Clinical Global Impression, Adverse effect, Extrapyramidal symptoms, Internal medicine, Prospective cohort study, Psychosis, Antipsychotic, Placebo, Pathology, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
3Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 1, 2024: 1, 2023: 1Per-year citation counts (last 5 years)
- References (count)
-
21Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.P.O. | 103 |
| abstract_inverted_index.Test | 172 |
| abstract_inverted_index.This | 38, 63 |
| abstract_inverted_index.been | 34 |
| abstract_inverted_index.dose | 126 |
| abstract_inverted_index.far. | 37 |
| abstract_inverted_index.from | 153 |
| abstract_inverted_index.have | 33 |
| abstract_inverted_index.mg/d | 114 |
| abstract_inverted_index.site | 246 |
| abstract_inverted_index.size | 12, 31 |
| abstract_inverted_index.test | 176 |
| abstract_inverted_index.that | 15 |
| abstract_inverted_index.week | 156 |
| abstract_inverted_index.will | 79, 83, 96, 129, 226, 268 |
| abstract_inverted_index.with | 25, 57, 76 |
| abstract_inverted_index.(PSP) | 149 |
| abstract_inverted_index.0–7 | 86 |
| abstract_inverted_index.Doses | 93 |
| abstract_inverted_index.Other | 191 |
| abstract_inverted_index.P.O., | 115 |
| abstract_inverted_index.PANSS | 187 |
| abstract_inverted_index.Paced | 168 |
| abstract_inverted_index.Scale | 182 |
| abstract_inverted_index.Sixth | 249 |
| abstract_inverted_index.Trial | 287 |
| abstract_inverted_index.after | 107 |
| abstract_inverted_index.aimed | 40 |
| abstract_inverted_index.could | 17 |
| abstract_inverted_index.first | 97 |
| abstract_inverted_index.large | 29 |
| abstract_inverted_index.meals | 108 |
| abstract_inverted_index.score | 150, 185 |
| abstract_inverted_index.serum | 196 |
| abstract_inverted_index.small | 10 |
| abstract_inverted_index.study | 39, 140, 236, 267 |
| abstract_inverted_index.total | 72, 184 |
| abstract_inverted_index.twice | 104 |
| abstract_inverted_index.(BDNF) | 200 |
| abstract_inverted_index.(GPT), | 177 |
| abstract_inverted_index.8–16 | 113 |
| abstract_inverted_index.Ethics | 232 |
| abstract_inverted_index.Peking | 247 |
| abstract_inverted_index.Serial | 170 |
| abstract_inverted_index.Social | 147 |
| abstract_inverted_index.before | 90, 264 |
| abstract_inverted_index.ethics | 241 |
| abstract_inverted_index.factor | 199 |
| abstract_inverted_index.follow | 281 |
| abstract_inverted_index.number | 289 |
| abstract_inverted_index.period | 89 |
| abstract_inverted_index.renal, | 218 |
| abstract_inverted_index.safety | 46 |
| abstract_inverted_index.sample | 11, 30 |
| abstract_inverted_index.sexual | 221 |
| abstract_inverted_index.social | 19, 51 |
| abstract_inverted_index.trial. | 70 |
| abstract_inverted_index.visits | 203 |
| abstract_inverted_index.weeks. | 124 |
| abstract_inverted_index.(MCCB), | 167 |
| abstract_inverted_index.(PANSS) | 183 |
| abstract_inverted_index.MATRICS | 163 |
| abstract_inverted_index.Maximum | 125 |
| abstract_inverted_index.Methods | 60 |
| abstract_inverted_index.adverse | 210 |
| abstract_inverted_index.battery | 166 |
| abstract_inverted_index.changes | 143, 161, 194, 212 |
| abstract_inverted_index.consent | 263 |
| abstract_inverted_index.events, | 211 |
| abstract_inverted_index.grooved | 174 |
| abstract_inverted_index.hepatic | 219 |
| abstract_inverted_index.include | 160, 193 |
| abstract_inverted_index.leading | 245 |
| abstract_inverted_index.mg/day. | 134 |
| abstract_inverted_index.primary | 136 |
| abstract_inverted_index.provide | 260 |
| abstract_inverted_index.related | 9 |
| abstract_inverted_index.scores. | 190 |
| abstract_inverted_index.studies | 13, 32 |
| abstract_inverted_index.suggest | 14 |
| abstract_inverted_index.undergo | 84 |
| abstract_inverted_index.washout | 88 |
| abstract_inverted_index.written | 261 |
| abstract_inverted_index.(PASAT), | 173 |
| abstract_inverted_index.5-factor | 188 |
| abstract_inverted_index.Addition | 171 |
| abstract_inverted_index.Auditory | 169 |
| abstract_inverted_index.Helsinki | 279 |
| abstract_inverted_index.Hospital | 250 |
| abstract_inverted_index.However, | 27 |
| abstract_inverted_index.Negative | 180 |
| abstract_inverted_index.Personal | 145 |
| abstract_inverted_index.Positive | 178 |
| abstract_inverted_index.Syndrome | 181 |
| abstract_inverted_index.analysis | 62 |
| abstract_inverted_index.approved | 238 |
| abstract_inverted_index.baseline | 154 |
| abstract_inverted_index.clinical | 69, 285 |
| abstract_inverted_index.endpoint | 137 |
| abstract_inverted_index.enrolled | 81 |
| abstract_inverted_index.included | 255 |
| abstract_inverted_index.informed | 262 |
| abstract_inverted_index.patients | 24, 56, 75, 152, 256 |
| abstract_inverted_index.pegboard | 175 |
| abstract_inverted_index.results. | 206 |
| abstract_inverted_index.strictly | 228 |
| abstract_inverted_index.subscale | 189 |
| abstract_inverted_index.symptoms | 225 |
| abstract_inverted_index.Moreover, | 207 |
| abstract_inverted_index.Secondary | 158 |
| abstract_inverted_index.according | 271 |
| abstract_inverted_index.alleviate | 18 |
| abstract_inverted_index.cognitive | 21, 53, 165 |
| abstract_inverted_index.committee | 242 |
| abstract_inverted_index.conducted | 270 |
| abstract_inverted_index.consensus | 164 |
| abstract_inverted_index.depending | 116 |
| abstract_inverted_index.endocrine | 214 |
| abstract_inverted_index.endpoints | 159, 192 |
| abstract_inverted_index.exceeding | 132 |
| abstract_inverted_index.functions | 54, 222 |
| abstract_inverted_index.gradually | 110 |
| abstract_inverted_index.improving | 50 |
| abstract_inverted_index.incidence | 208 |
| abstract_inverted_index.increased | 111 |
| abstract_inverted_index.metabolic | 216 |
| abstract_inverted_index.monitored | 229 |
| abstract_inverted_index.performed | 35 |
| abstract_inverted_index.profiles, | 217 |
| abstract_inverted_index.recorded. | 231 |
| abstract_inverted_index.requested | 258 |
| abstract_inverted_index.research. | 286 |
| abstract_inverted_index.symptoms, | 121 |
| abstract_inverted_index.University | 248 |
| abstract_inverted_index.enrolment. | 265 |
| abstract_inverted_index.principles | 274, 283 |
| abstract_inverted_index.single-arm | 68 |
| abstract_inverted_index.2018–18), | 252 |
| abstract_inverted_index.Declaration | 277 |
| abstract_inverted_index.NCT03784222 | 290 |
| abstract_inverted_index.Performance | 148 |
| abstract_inverted_index.blonanserin | 6, 16, 48, 91, 95, 128 |
| abstract_inverted_index.investigate | 42 |
| abstract_inverted_index.patient’s | 118 |
| abstract_inverted_index.Introduction | 0 |
| abstract_inverted_index.dysfunctions | 22 |
| abstract_inverted_index.multicentre, | 67 |
| abstract_inverted_index.neurotrophic | 198 |
| abstract_inverted_index.prospective, | 66 |
| abstract_inverted_index.registration | 288 |
| abstract_inverted_index.brain-derived | 197 |
| abstract_inverted_index.corresponding | 202 |
| abstract_inverted_index.dissemination | 234 |
| abstract_inverted_index.effectiveness | 44 |
| abstract_inverted_index.first-episode | 58, 77 |
| abstract_inverted_index.schizophrenia | 78 |
| abstract_inverted_index.extrapyramidal | 224 |
| abstract_inverted_index.schizophrenia. | 26, 59 |
| abstract_inverted_index.administration. | 92 |
| abstract_inverted_index.characteristics | 4 |
| abstract_inverted_index.pharmacological | 3 |
| cited_by_percentile_year.max | 95 |
| cited_by_percentile_year.min | 89 |
| countries_distinct_count | 3 |
| institutions_distinct_count | 12 |
| citation_normalized_percentile.value | 0.61237564 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |