search
Back to results

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

Primary Purpose

First Episode Schizophrenia, Social Function, Cognition Function

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Blonanserin
MRI and serum BDNF
Sponsored by
Sumitomo Pharma (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for First Episode Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beijing Huilongguan Hospital
  • Peking University Sixth HospitalRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Shanghai Mental Health CenterRecruiting
  • Xi'an Mental Health Center
  • West China Hospital, Sichuan UniveristyRecruiting
  • Tianjin Mental Health Center
  • The First Affiliated hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

treatment group

control group

Arm Description

188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test

60 subjects without schizophrenia, only receiving MRI and/or serum BDNF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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.
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.
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
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

Full Information

First Posted
November 28, 2018
Last Updated
April 11, 2023
Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03784222
Brief Title
Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
Official Title
Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Schizophrenia, Social Function, Cognition Function, Blonanserin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
Arm Title
control group
Arm Type
Other
Arm Description
60 subjects without schizophrenia, only receiving MRI and/or serum BDNF
Intervention Type
Drug
Intervention Name(s)
Blonanserin
Intervention Description
patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
Intervention Type
Other
Intervention Name(s)
MRI and serum BDNF
Intervention Description
60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test
Primary Outcome Measure Information:
Title
changes in personal and social performance (PSP) scores at week 26
Description
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
Secondary Outcome Measure Information:
Title
changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group
Description
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
Title
changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group
Description
PASAT is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention
Time Frame
26 weeks
Title
changes in Groove Pegboard Test (GPT) at week 26 in treatment group
Description
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
Title
changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group
Description
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.
Time Frame
26 weeks
Title
changes in PANSS five-factor model scores at week 26 in treatment group
Description
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
Title
changes in PSP at every visit in treatment group during 26 weeks
Description
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
Title
changes in MCCB at every visit in treatment group during 26 weeks
Description
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
Other Pre-specified Outcome Measures:
Title
changes in magnetic resonance imaging (MRI) at week 26 in treatment group
Description
observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions
Time Frame
26 weeks
Title
changes in MRI at every visit in treatment group during 26 weeks
Description
observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions
Time Frame
baseline, week 8, week 26
Title
difference of MRI results between treatment group and control group at baseline
Description
observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions
Time Frame
baseline
Title
changes in serum Brain-derived neurotrophic factor (BDNF) at week 26 in treatment group
Description
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
Time Frame
26 weeks
Title
difference of serum BDNF results between treatment group and control group at baseline
Description
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
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyun Li
Phone
+86-21-23065749
Email
lihaiyun@dsmpharm.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Yu, MD
Organizational Affiliation
Peking University Sixth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Huilongguan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100096
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Fude, MD
Email
Yangfd200@126.com
First Name & Middle Initial & Last Name & Degree
Yang Fude, MD
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Yu
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhening Liu, MD
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Sheng, MD
Facility Name
Xi'an Mental Health Center
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Wu
Facility Name
West China Hospital, Sichuan Univeristy
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Deng, MD
Facility Name
Tianjin Mental Health Center
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Wang, MD
Facility Name
The First Affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaohua Hu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35443947
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs