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

Study Overview
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Brief Summary
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This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients

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

Conditions
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First Episode Schizophrenia, Social Function, Cognition Function, Blonanserin

Intervention / Treatment
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* Drug: Blonanserin
* Other: MRI and serum BDNF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test | Drug: Blonanserin<br>* patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability<br>Other: MRI and serum BDNF<br>* 60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test<br>|
| Other: control group<br>60 subjects without schizophrenia, only receiving MRI and/or serum BDNF | Other: MRI and serum BDNF<br>* 60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in personal and social performance (PSP) scores at week 26 | 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 | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group | MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms | 26 weeks | 
| changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group | PASAT is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention | 26 weeks | 
| changes in Groove Pegboard Test (GPT) at week 26 in treatment group | GPT is a test used to assess fine motor skills and speed. this test measure the time it takes to put 25 nails in the pegborad in a defined order | 26 weeks | 
| changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group | PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales. | 26 weeks | 
| changes in PANSS five-factor model scores at week 26 in treatment group | five-factor model is another model of PANSS. It is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales. | 26 weeks | 
| changes in PSP at every visit in treatment group during 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 | baseline, week 8, week 26 | 
| changes in MCCB at every visit in treatment group during 26 weeks | MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms | baseline, week 8, week 26 |