Status:
TERMINATED
Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
Lead Sponsor:
Sumitomo Pharma (Suzhou) Co., Ltd.
Conditions:
First Episode Schizophrenia
Social Function
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03784222
Start Date
January 22 2019
End Date
November 22 2022
Last Update
April 19 2024
Active Locations (8)
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1
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China, 100096
2
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
3
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
4
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200000