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

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 analysisThis 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 disseminationThe 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 numberNCT03784222.

Improvement of social functioning in patients with first-episode schizophrenia using blonanserin treatment: a prospective, multi-centre, single-arm clinical trial

“…This study was a prospective, multi-centre, single-arm clinical trial, ethically considering the use of placebo was not recommended for patients with first-episode schizophrenia ( 13 ), as previously described in detail ( 14 ). From January 2019 to September 2022, patients were recruited from 9 hospitals in China.…”

“…Patients were eligible for the study if they met the following criteria: (1) schizophrenia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) or International Classification of disease-10 (ICD-10); (2) PANSS total score ≥70; (3) age of 18-45 years; (4) first-episode patients with disease course less than 5 years; (5) ≥9 years of education; (6) no prior systematic antipsychotic treatment, single continuous treatment less than 6 weeks, or total treatment duration less than 6 months; (7) capable of reading and understanding Chinese characters; (8) provide written informed consent. Patients excluded from the study were previously described in detail ( 14 ).…”

“…Throughout this period, assessment data, adverse effects (AEs), and concomitant medications were consistently documented. Moreover, some drugs were prohibited during the study period, as previously described in detail ( 14 ).…”

“…(3) age of 18-45 years; (4) first-episode patients with disease course less than 5 years; (5) ≥9 years of education; (6) no prior systematic antipsychotic treatment, single continuous treatment less than 6 weeks, or total treatment duration less than 6 months; (7) capable of reading and understanding Chinese characters; (8) provide written informed consent. Patients excluded from the study were previously described in detail (14).…”