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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Criteria

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