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

Sumitomo Pharma

Status and phase: Terminated; Phase 4

Conditions: Blonanserin; Social Function; First Episode Schizophrenia; Cognition Function

Treatments: Other: MRI and serum BDNF; Drug: Blonanserin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03784222

DSPCLON-002

Details and patient eligibility

About

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

Enrollment: 102 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

treatment group

Experimental group

Description:

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

Treatment:

Other: MRI and serum BDNF

Drug: Blonanserin

control group

Other group

Description:

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

Treatment:

Other: MRI and serum BDNF