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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-22

Study Completion Date

2022-11-22

Brief Summary

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

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Detailed Description

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Conditions

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First Episode Schizophrenia Social Function Cognition Function Blonanserin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group

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

Group Type EXPERIMENTAL

Blonanserin

Intervention Type DRUG

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

MRI and serum BDNF

Intervention Type OTHER

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

control group

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

Group Type OTHER

MRI and serum BDNF

Intervention Type OTHER

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

Interventions

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Blonanserin

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

Intervention Type DRUG

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes