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

April 17, 2024 updated by: Sumitomo Pharma (Suzhou) Co., Ltd.
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100096
        • Beijing Huilongguan Hospital
      • Beijing, Beijing, China
        • Peking University Sixth Hospital
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Shanghai Mental Health Center
    • Shanxi
      • Xi'an, Shanxi, China
        • Xi'an Mental Health Center
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan Univeristy
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Mental Health Center
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of Zhejiang University school of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: treatment group
188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
Drug: Blonanserin
patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
Other: 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
Other: control group
60 subjects without schizophrenia, only receiving MRI and/or serum BDNF
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
changes in personal and social performance (PSP) scores at week 26
Time Frame: 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
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group
Time Frame: 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
26 weeks
changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group
Time Frame: 26 weeks
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
Time Frame: 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
26 weeks
changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group
Time Frame: 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.
26 weeks
changes in PANSS five-factor model scores at week 26 in treatment group
Time Frame: 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.
26 weeks
changes in PSP at every visit in treatment group during 26 weeks
Time Frame: 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
baseline, week 8, week 26
changes in MCCB at every visit in treatment group during 26 weeks
Time Frame: 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
baseline, week 8, week 26

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes in magnetic resonance imaging (MRI) at week 26 in treatment group
Time Frame: 26 weeks
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
Time Frame: 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
Time Frame: 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
Time Frame: 26 weeks
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sumitomo Pharma (Suzhou) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xin Yu, MD, Peking University Sixth Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DSPCLON-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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