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

NCT03784222 | Terminated Phase 4

• 1 other identifier: DSPCLON-002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

First Episode Schizophrenia; Social Function; Cognition Function; Blonanserin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group

  26 weeks

• changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group

  26 weeks

• changes in Groove Pegboard Test (GPT) at week 26 in treatment group

  26 weeks

• changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group

  26 weeks

• changes in PANSS five-factor model scores at week 26 in treatment group

  26 weeks

Other Outcomes (5)

• changes in magnetic resonance imaging (MRI) at week 26 in treatment group

  26 weeks

• changes in MRI at every visit in treatment group during 26 weeks

  baseline, week 8, week 26

• difference of MRI results between treatment group and control group at baseline

  baseline

Study Arms (2)

treatment group

EXPERIMENTAL

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

Drug: Blonanserin; Other: MRI and serum BDNF

control group

OTHER

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

Other: MRI and serum BDNF

Interventions

Blonanserin DRUG

patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability

treatment group

MRI and serum BDNF OTHER

60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test

control group; treatment group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sumitomo Pharma (Suzhou) Co., Ltd.: lead

Study Sites (8)

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, 100096, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

Location

Xi'an Mental Health Center

Xi’an, Shanxi, China

Location

West China Hospital, Sichuan Univeristy

Chengdu, Sichuan, China

Location

Tianjin Mental Health Center

Tianjin, Tianjin Municipality, China

Location

The First Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 35443947 DERIVED

MeSH Terms

Conditions

Social Adjustment

Interventions

blonanserin; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Xin Yu, MD

  Peking University Sixth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 21, 2018
• Study Start: January 22, 2019
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)