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

This study is currently recruiting participants.

Verified January 2012 by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Sponsor:

Information provided by (Responsible Party):

Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01516424

First received: January 18, 2012

Last updated: November 14, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2012

Last Updated Date

November 14, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean change in PANSS total score [ Time Frame: week 8 ] [ Designated as safety issue: No ]

Mean change in PANSS total score from baseline at Week 8

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01516424 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean change in CGI-S score [ Time Frame: week 8 ] [ Designated as safety issue: No ]
Mean change in CGI-S score from baseline at Week 8
Mean change in PANSS negative, positive and general scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Mean change in PANSS negative, positive and general scale from baseline at Week 8
Mean change in PANSS 5-factor model [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Mean change in PANSS 5-factor model from baseline at Week 8
Mean change in PANSS symptom scores [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Mean change in PANSS symptom scores from baseline at Week 8
Mean change in PANSS symptom scores from baseline at each Visit [ Time Frame: Each Visit ] [ Designated as safety issue: No ]
Mean change in PANSS symptom scores from baseline at each Visit

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

A Randomized, Double-blinded, Double-dummy, Paralell-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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Blonanserin
tablet,4mg,b.i.d
Drug: Risperidone
tablet,2mg,b.i.d,

Study Arm (s)

Active Comparator: Risperidone, Shizophrenia
Intervention: Drug: Risperidone
Experimental: Blonanserin, Schizophrenia
Intervention: Drug: Blonanserin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

260

Estimated Completion Date

June 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject met DSM-IV-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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Luo Xiaoyan, Director

0086-10-57322000

luo@dsmpharm.com.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01516424

Other Study ID Numbers ^ICMJE

D4906011

Has Data Monitoring Committee

Yes

Responsible Party

Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Study Sponsor ^ICMJE

Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Niufan Gu, MD

Shanghai Mental Health Center

Information Provided By

Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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