Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

Study 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

Official Title
-----------------
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Blonanserin
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blonanserin<br>Antipsychotics | Drug: Blonanserin<br>* Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.<br>* Other names: Lonasen;|
| Active Comparator: Risperidone<br>Antipsychotics | Drug: Risperidone<br>* Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.<br>* Other names: Risperdal;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 | 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) | From baseline to the end of study、week 8(day 56)or before other antipsychotic taken. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in PANSS Subscale Score at the End of Treatment | Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline | week 8 | 
| Mean Change in PANSS 5-factor Model | Mean change in PANSS 5-factor model from baseline at Week 8 | Week 8 | 
| Mean Change in PANSS Symptom Scores | Mean change in PANSS symptom scores from baseline at Week 8 | Week 8 | 
| Mean Change in PANSS Symptom Scores From Baseline at Each Visit | Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8 | Each Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blonanserin