Blonanserin, Cognition Function, First Episode Schizophrenia, Social Function
Conditions
Brief summary
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Interventions
DRUGBlonanserin
patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
OTHERMRI and serum BDNF
60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test
Sponsors
Sumitomo Pharma (Suzhou) Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in personal and social performance (PSP) scores at week 26 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group | 26 weeks | PASAT is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention |
| changes in Groove Pegboard Test (GPT) at week 26 in treatment group | 26 weeks | 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 |
| changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group | 26 weeks | 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. |
| changes in PANSS five-factor model scores at week 26 in treatment group | 26 weeks | 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. |
| changes in PSP at every visit in treatment group during 26 weeks | baseline, week 8, 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 |
| changes in MCCB at every visit in treatment group during 26 weeks | baseline, week 8, week 26 | 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 |
| changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| difference of MRI results between treatment group and control group at baseline | baseline | observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions |
| changes in serum Brain-derived neurotrophic factor (BDNF) at week 26 in treatment group | 26 weeks | BDNF, is a protein that, in humans, is encoded by the BDNF gene. BDNF is a member of the neurotrophin family of growth factors, which are related to the canonical nerve growth factor. Neurotrophic factors are found in the brain and the periphery |
| difference of serum BDNF results between treatment group and control group at baseline | baseline | BDNF, is a protein that, in humans, is encoded by the BDNF gene. BDNF is a member of the neurotrophin family of growth factors, which are related to the canonical nerve growth factor. Neurotrophic factors are found in the brain and the periphery |
| changes in MRI at every visit in treatment group during 26 weeks | baseline, week 8, week 26 | observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions |
| changes in magnetic resonance imaging (MRI) at week 26 in treatment group | 26 weeks | observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions |
Countries
China
Outcome results
None listed