Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01516424
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : November 26, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Blonanserin Drug: Risperidone Phase 3

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Blonanserin
Antipsychotics
 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.
Other Name: Lonasen
Active Comparator: Risperidone
Antipsychotics
 Drug: 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.
Other Name: Risperdal


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mean Change in PANSS Subscale Score at the End of Treatment [ Time Frame: week 8 ]
    Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline

  2. Mean Change in PANSS 5-factor Model [ Time Frame: Week 8 ]
    Mean change in PANSS 5-factor model from baseline at Week 8

  3. Mean Change in PANSS Symptom Scores [ Time Frame: Week 8 ]
    Mean change in PANSS symptom scores from baseline at Week 8

  4. Mean Change in PANSS Symptom Scores From Baseline at Each Visit [ Time Frame: Each Visit ]
    Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516424


Locations
Layout table for location information
China, Beijing
Beijing Anding Hospital
Beijing, Beijing, China, 100088
Beijing Huilongguan Hospital
Beijing, Beijing, China, 100096
Peking University Sixth Hospital
Beijing, Beijing, China, 100191
China, Guangdong
Guangzhou Brain Hospital
Guangzhou, Guangdong, China, 510170
China, Hebei
Hebei Province Mental Health Center
Baoding, Hebei, China, 071000
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
China, Henan
Henan Provincial Mental Hospital
Xinxiang, Henan, China, 453002
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Hunan Province Brain Hospital
Changsha, Hunan, China, 410007
China, Jiangsu
Nanjing Brain Hospital
Nanjing, Jiangsu, China, 210029
Wuxi Mental Health Center
Wuxi, Jiangsu, China, 214000
China, Shanghai
Shanghai Mental Health Center
Shang Hai, Shanghai, China, 200030
China, Shanxi
Xi'an Mental Health Center
Xi'an, Shanxi, China, 710061
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin Anding Hospital
Tianjin, Tianjin, China, 300222
China, Yunnan
First Affiliated Hospital of Kunming Medical University
Kun Ming, Yunnan, China, 650032
Sponsors and Collaborators
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Niufan Gu, MD Shanghai Mental Health Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01516424    
Other Study ID Numbers: D4906011
First Posted: January 24, 2012    Key Record Dates
Results First Posted: November 26, 2018
Last Update Posted: November 27, 2018
Last Verified: May 2018
Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:
Blonanserin
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents