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

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: Terminated
• Conditions: First Episode Schizophrenia; Social Function; Cognition Function; Blonanserin
• Intervention / Treatment: Drug: Blonanserin; Other: MRI and serum BDNF

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in magnetic resonance imaging (MRI) at week 26 in treatment group	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	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	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	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	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

• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
• Investigators: Principal Investigator: Xin Yu, MD, Peking University Sixth Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID 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