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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01516424
First received: January 18, 2012
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Blonanserin
Drug: Risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 267
Study Start Date: February 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Risperidone, Schizophrenia Drug: Risperidone
tablet,2mg,b.i.d,
Experimental: Blonanserin, Schizophrenia Drug: Blonanserin
tablet,4mg,b.i.d

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516424

Locations
China, Beijing
Peking University Sixth Hospital
Beijing, Beijing, China, 100191
Beijing Anding Hospital
Beijing, Beijing, China, 100088
Beijing Huilongguan Hospital
Beijing, Beijing, China, 100096
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
Hunan Province Brain Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
China, Jiangsu
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Wuxi Mental Health Center
Wuxi, Jiangsu, China
China, Shanghai
Shanghai Mental Health Center
Shang Hai, Shanghai, China
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
Sponsors and Collaborators
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Investigators
Principal Investigator: Niufan Gu, MD Shanghai Mental Health Center
  More Information

No publications provided

Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01516424     History of Changes
Other Study ID Numbers: D4906011
Study First Received: January 18, 2012
Last Updated: December 2, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:
Blonanserin

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 24, 2014