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

Last updated: November 25, 2018
Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Mood Disorders

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT01516424
D4906011
  • Ages 18-64
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-TextRevision(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 inhospital.

  • Subjects or their legal guardians have signed the written informed consent form.

Exclusion

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

Study Design

Total Participants: 267
Study Start date:
February 01, 2012
Estimated Completion Date:
February 28, 2013

Study 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

Connect with a study center

  • Beijing Anding Hospital

    Beijing, Beijing 100088
    China

    Site Not Available

  • Beijing Huilongguan Hospital

    Beijing, Beijing 100096
    China

    Site Not Available

  • Peking University Sixth Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Guangzhou Brain Hospital

    Guangzhou, Guangdong 510170
    China

    Site Not Available

  • Hebei Province Mental Health Center

    Baoding, Hebei 071000
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Henan Provincial Mental Hospital

    Xinxiang, Henan 453002
    China

    Site Not Available

  • Hunan Province Brain Hospital

    Changsha, Hunan 410007
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Site Not Available

  • Nanjing Brain Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Wuxi Mental Health Center

    Wuxi, Jiangsu 214000
    China

    Site Not Available

  • Shanghai Mental Health Center

    Shang Hai, Shanghai 200030
    China

    Site Not Available

  • Xi'an Mental Health Center

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Anding Hospital

    Tianjin, Tianjin 300222
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kun Ming, Yunnan 650032
    China

    Site Not Available

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