Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 102
- 试验地点
- 8
- 主要终点
- changes in personal and social performance (PSP) scores at week 26
研究概览
简要总结
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schizophrenia patients diagnosis either with DSM-5 criteria or ICD-10;
- •PANSS total score ≥70;
- •Males or Females aged 18-45 years;
- •With disease course less than 5 years and during their first episode;
- •≥9 years of education;
- •Without receiving systematic antipsychotic treatment, or receiving continuous antipsychotic treatment for less than 6 weeks and receiving antipsychotic treatment for less than 6 months in total;
- •Ability to read and understand Chinese;
- •Provision of written informed consent
排除标准
- •Severe or unstable physical diseases judged by investigators;
- •Loss of consciousness more than 1 hour due to any reason in the past 1 year;
- •Current substance misuse (in 3 months) or any substance dependence;
- •Pregnant or lactating woman;
- •Patients with attempted suicide history, severe suicidal ideation or behaviour;
- •Mental retardation;
- •Contradict to the study drugs;
- •Patients taken other investigation products in the past 30 days before entry;
- •Patients ever taken blonanserin before;
- •Any current medical condition that would interfere with the assessment of efficacy;
- •Physical symptoms of acute deterioration requiring hospitalization or increased intensive care;
- •Significant muscle tension or Parkinson's disease;
- •Clinically significant abnormal laboratory test results (blood, urine, and blood biochemical analysis);
- •Clinically significant Abnormal electrocardiogram as judged by researchers;
- •Participants continuously using sedative drugs, or anticholinergic agents within 3 months of the study;
- •Those who had undergone electroconvulsive therapy within 3 month of the study;
- •Those who had received long-acting injection treatment within 3 month of the study;
- •Those who could not swallow medication with water;
- •Subjects judged by the investigator in charge as inappropriate for the study
研究组 & 干预措施
treatment group
188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
干预措施: Blonanserin (Drug)
treatment group
188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
干预措施: MRI and serum BDNF (Other)
control group
60 subjects without schizophrenia, only receiving MRI and/or serum BDNF
干预措施: MRI and serum BDNF (Other)
结局指标
主要结局
changes in personal and social performance (PSP) scores at week 26
时间窗: 26 weeks
PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome
次要结局
- changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group(26 weeks)
- changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group(26 weeks)
- changes in PANSS five-factor model scores at week 26 in treatment group(26 weeks)
- changes in MCCB at every visit in treatment group during 26 weeks(baseline, week 8, week 26)
- changes in Groove Pegboard Test (GPT) at week 26 in treatment group(26 weeks)
- changes in PSP at every visit in treatment group during 26 weeks(baseline, week 8, week 26)
- changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group(26 weeks)