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Clinical Trial NCT03784222 for First Episode Schizophrenia, Social Function, Cognition Function, Blonanserin is terminated. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients Phase 4 102 Multi-Center Open-Label

Terminated
Clinical Trial NCT03784222 is designed to study Treatment for First Episode Schizophrenia, Social Function, Cognition Function, Blonanserin. It is a Phase 4 interventional study that is terminated, having started on January 22, 2019, with plans to enroll 102 participants. Led by Sumitomo Pharma (Suzhou) Co., Ltd., it is expected to complete by November 22, 2022. The latest data from ClinicalTrials.gov was last updated on April 19, 2024.
Brief Summary
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Official Title

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

Conditions
First Episode SchizophreniaSocial FunctionCognition FunctionBlonanserin
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • DSPCLON-002
NCT ID Number
NCT03784222
Start Date (Actual)
2019-01-22
Last Update Posted
2024-04-19
Completion Date (Estimated)
2022-11-22
Enrollment (Estimated)
102
Study Type
Interventional
PHASE
Phase 4
Status
Terminated
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentaltreatment group
188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
Blonanserin
patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
MRI and serum BDNF
60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test
Othercontrol group
60 subjects without schizophrenia, only receiving MRI and/or serum BDNF
MRI and serum BDNF
60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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
Sumitomo Pharma (Suzhou) Co., Ltd. logoSumitomo Pharma (Suzhou) Co., Ltd.
No contact data.
8 Study Locations in 1 Countries

Beijing Municipality

Beijing Huilongguan Hospital, Beijing, Beijing Municipality, 100096, China
Peking University Sixth Hospital, Beijing, Beijing Municipality, China

Hunan

The Second Xiangya Hospital of Central South University, Changsha, Hunan, China

Shanghai Municipality

Shanghai Mental Health Center, Shanghai, Shanghai Municipality, 200000, China

Shanxi

Xi'an Mental Health Center, Xi’an, Shanxi, China

Sichuan

West China Hospital, Sichuan Univeristy, Chengdu, Sichuan, China

Tianjin Municipality

Tianjin Mental Health Center, Tianjin, Tianjin Municipality, China

Zhejiang

The First Affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China