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

First Episode Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03784222
• Other study ID #: DSPCLON-002
• Status: Terminated
• Phase: Phase 4
• Start date: January 22, 2019
• Est. completion date: November 22, 2022

Study information

• Verified date: April 2024
• Source: Sumitomo Pharma (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blonanserin
• Cognition Function
• First Episode Schizophrenia
• Schizophrenia
• Social Function

Intervention

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

Locations

Country	Name	City	State
China	Beijing Huilongguan Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan Univeristy	Chengdu	Sichuan
China	The First Affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Tianjin Mental Health Center	Tianjin	Tianjin
China	Xi'an Mental Health Center	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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