Clinical trial
Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
Name
DSPCLON-002
Description
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Trial arms
Trial start
2019-01-22
Estimated PCD
2022-11-22
Trial end
2022-11-22
Status
Terminated
Phase
Early phase I
Treatment
Blonanserin
patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
Arms:
treatment group
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
Arms:
control group, treatment group
Size
102
Primary endpoint
changes in personal and social performance (PSP) scores at week 26
26 weeks
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 102, 'type': 'ACTUAL'}}
Updated at
2024-04-19
1 organization
Organization
Sumitomo Pharma