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

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ClinicalTrials.gov Identifier: NCT01516424
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

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 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
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Risperidone, Schizophrenia Drug: Risperidone
tablet,2mg,b.i.d,
Experimental: Blonanserin, Schizophrenia Drug: Blonanserin
tablet,4mg,b.i.d



Primary Outcome Measures :
  1. Mean change in PANSS total score [ Time Frame: week 8 ]
    Mean change in PANSS total score from baseline at Week 8


Secondary Outcome Measures :
  1. Mean change in CGI-S score [ Time Frame: week 8 ]
    Mean change in CGI-S score from baseline at Week 8

  2. Mean change in PANSS negative, positive and general scale [ Time Frame: Week 8 ]
    Mean change in PANSS negative, positive and general scale from baseline at Week 8

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

  4. Mean change in PANSS symptom scores [ Time Frame: Week 8 ]
    Mean change in PANSS symptom scores from baseline at Week 8

  5. 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



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

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
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
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

Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01516424     History of Changes
Other Study ID Numbers: D4906011
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013

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

Additional relevant 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