Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
- Conditions
- Cognition FunctionFirst Episode SchizophreniaSocial FunctionBlonanserin
- Interventions
- Other: MRI and serum BDNF
- Registration Number
- NCT03784222
- Lead Sponsor
- Sumitomo Pharma (Suzhou) Co., Ltd.
- Brief Summary
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group MRI and serum BDNF 60 subjects without schizophrenia, only receiving MRI and/or serum BDNF treatment group MRI and serum BDNF 188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test treatment group Blonanserin 188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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 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 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 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 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.
Trial Locations
- Locations (8)
Peking University Sixth Hospital
🇨🇳Beijing, Beijing, China
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China
Beijing Huilongguan Hospital
🇨🇳Beijing, Beijing, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xi'an Mental Health Center
🇨🇳Xi'an, Shanxi, China
West China Hospital, Sichuan Univeristy
🇨🇳Chengdu, Sichuan, China
The First Affiliated hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Tianjin Mental Health Center
🇨🇳Tianjin, Tianjin, China