A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sumitomo Pharma (Suzhou) Co., Ltd.
- Enrollment
- 267
- Locations
- 16
- Primary Endpoint
- Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
Overview
Brief Summary
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
Detailed Description
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
Trial drugs:
- Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets
- Risperidone group: Risperidone tablets+Blonanserin mimetic tablets
Objectives of Study :
To evaluate the efficacy and safety of Blonanserin in treating schizophrenia
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
- •Patients are 18≤age\<65 years of age on the day when informed consent is obtained.
- •Subject had a PANSS total score ≥70 and 120≥ at Screening
- •Subject had a score ≥4 on the PANSS at Screening and Baseline.
- •Subjects are willing and able to comply with study protocol including treatment in hospital.
- •Subjects or their legal guardians have signed the written informed consent form.
Exclusion Criteria
- •The subject was treatment with other Investigate product within 30 days.
- •Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
- •Subject had a history of treatment with clozapine within 28 days.
- •Subject With parkinson disease,etc
Arms & Interventions
Blonanserin
Antipsychotics
Intervention: Blonanserin (Drug)
Risperidone
Antipsychotics
Intervention: Risperidone (Drug)
Outcomes
Primary Outcomes
Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
Time Frame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.
Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores\<70 is the normal,but the scores\>120 is more serious.Change=(Week 8 Score - Baseline score)
Secondary Outcomes
- Mean Change in PANSS Subscale Score at the End of Treatment(week 8)
- Mean Change in PANSS 5-factor Model(Week 8)
- Mean Change in PANSS Symptom Scores(Week 8)
- Mean Change in PANSS Symptom Scores From Baseline at Each Visit(Each Visit)