This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
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
Time frame: 26 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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.
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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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: baseline, week 8, week 26