Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
Overview
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Sumitomo Pharma (Suzhou) Co., Ltd.
- Enrollment
- 102
- Locations
- 8
- Primary Endpoint
- changes in personal and social performance (PSP) scores at week 26
Overview
Brief Summary
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
Arms & Interventions
treatment group
188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
Intervention: Blonanserin (Drug)
treatment group
188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
Intervention: MRI and serum BDNF (Other)
control group
60 subjects without schizophrenia, only receiving MRI and/or serum BDNF
Intervention: MRI and serum BDNF (Other)
Outcomes
Primary Outcomes
changes in personal and social performance (PSP) scores at week 26
Time Frame: 26 weeks
PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome
Secondary Outcomes
- changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group(26 weeks)
- changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group(26 weeks)
- changes in PANSS five-factor model scores at week 26 in treatment group(26 weeks)
- changes in MCCB at every visit in treatment group during 26 weeks(baseline, week 8, week 26)
- changes in Groove Pegboard Test (GPT) at week 26 in treatment group(26 weeks)
- changes in PSP at every visit in treatment group during 26 weeks(baseline, week 8, week 26)
- changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group(26 weeks)