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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516424
• Other study ID #: D4906011
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2018
• Source: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Blonanserin
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
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.

Locations

Country	Name	City	State
China	Hebei Province Mental Health Center	Baoding	Hebei
China	Beijing Anding Hospital	Beijing	Beijing
China	Beijing Huilongguan Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	Hunan Province Brain Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Guangzhou Brain Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	First Affiliated Hospital of Kunming Medical University	Kun Ming	Yunnan
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Shanghai Mental Health Center	Shang Hai	Shanghai
China	Tianjin Anding Hospital	Tianjin	Tianjin
China	Wuxi Mental Health Center	Wuxi	Jiangsu
China	Xi'an Mental Health Center	Xi'an	Shanxi
China	Henan Provincial Mental Hospital	Xinxiang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mean Change in PANSS 5-factor Model	Mean change in PANSS 5-factor model from baseline at Week 8	Week 8
Secondary	Mean Change in PANSS Symptom Scores	Mean change in PANSS symptom scores from baseline at Week 8	Week 8
Secondary	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