A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
267
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.
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.
Beijing Anding Hospital
Beijing, Beijing Municipality, China
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
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)
Time frame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.
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
Time frame: week 8
Mean Change in PANSS 5-factor Model
Mean change in PANSS 5-factor model from baseline at Week 8
Time frame: Week 8
Mean Change in PANSS Symptom Scores
Mean change in PANSS symptom scores from baseline at Week 8
Time frame: 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
Time frame: Each Visit
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Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Guangzhou Brain Hospital
Guangzhou, Guangdong, China
Hebei Province Mental Health Center
Baoding, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial Mental Hospital
Xinxiang, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Province Brain Hospital
Changsha, Hunan, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
...and 6 more locations