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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | 188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test |
|
| control group | Other | 60 subjects without schizophrenia, only receiving MRI and/or serum BDNF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blonanserin | Drug | patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in magnetic resonance imaging (MRI) at week 26 in treatment group | observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions | 26 weeks |
| changes in MRI at every visit in treatment group during 26 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xin Yu, MD | Peking University Sixth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Huilongguan Hospital | Beijing | Beijing Municipality | 100096 | China | ||
| Peking University Sixth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35443947 | Derived | Pu C, Lei L, Yang F, Deng H, Sheng J, Liu Z, Hu S, Wang L, Wu B, Bo Q, Inoue Y, Yu X. 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. BMJ Open. 2022 Apr 20;12(4):e054079. doi: 10.1136/bmjopen-2021-054079. |
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| MRI and serum BDNF | Other | 60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test |
|
| 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 |
observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions |
| baseline, week 8, week 26 |
| difference of MRI results between treatment group and control group at baseline | observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions | baseline |
| changes in serum Brain-derived neurotrophic factor (BDNF) at week 26 in treatment group | 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 | 26 weeks |
| difference of serum BDNF results between treatment group and control group at 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 | baseline |
| Beijing |
| Beijing Municipality |
| China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200000 | China |
| Xi'an Mental Health Center | Xi’an | Shanxi | China |
| West China Hospital, Sichuan Univeristy | Chengdu | Sichuan | China |
| Tianjin Mental Health Center | Tianjin | Tianjin Municipality | China |
| The First Affiliated hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D012917 | Social Adjustment |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C079310 | blonanserin |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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