search
Back to results

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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Blonanserin
Risperidone
Sponsored by
Sumitomo Pharma (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Blonanserin

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anding Hospital
  • Beijing Huilongguan Hospital
  • Peking University Sixth Hospital
  • Guangzhou Brain Hospital
  • Hebei Province Mental Health Center
  • The First Affiliated Hospital of Harbin Medical University
  • Henan Provincial Mental Hospital
  • The Second Xiangya Hospital of Central South University
  • Hunan Province Brain Hospital
  • Nanjing Brain Hospital
  • Wuxi Mental Health Center
  • Shanghai Mental Health Center
  • Xi'an Mental Health Center
  • West China Hospital, Sichuan University
  • Tianjin Anding Hospital
  • First Affiliated Hospital of Kunming Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blonanserin

Risperidone

Arm Description

Antipsychotics

Antipsychotics

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Mean Change in PANSS 5-factor Model
Mean change in PANSS 5-factor model from baseline at Week 8
Mean Change in PANSS Symptom Scores
Mean change in PANSS symptom scores from baseline at 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

Full Information

First Posted
January 18, 2012
Last Updated
November 25, 2018
Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01516424
Brief Title
Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
Official Title
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Blonanserin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blonanserin
Arm Type
Experimental
Arm Description
Antipsychotics
Arm Title
Risperidone
Arm Type
Active Comparator
Arm Description
Antipsychotics
Intervention Type
Drug
Intervention Name(s)
Blonanserin
Other Intervention Name(s)
Lonasen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
Description
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.
Secondary Outcome Measure Information:
Title
Mean Change in PANSS Subscale Score at the End of Treatment
Description
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
Title
Mean Change in PANSS 5-factor Model
Description
Mean change in PANSS 5-factor model from baseline at Week 8
Time Frame
Week 8
Title
Mean Change in PANSS Symptom Scores
Description
Mean change in PANSS symptom scores from baseline at Week 8
Time Frame
Week 8
Title
Mean Change in PANSS Symptom Scores From Baseline at Each Visit
Description
Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8
Time Frame
Each Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niufan Gu, MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anding Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Beijing Huilongguan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100096
Country
China
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Guangzhou Brain Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510170
Country
China
Facility Name
Hebei Province Mental Health Center
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Henan Provincial Mental Hospital
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453002
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Hunan Province Brain Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Wuxi Mental Health Center
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Facility Name
Shanghai Mental Health Center
City
Shang Hai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Xi'an Mental Health Center
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kun Ming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs