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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Blonanserin; Drug: Risperidone

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
• Enrollment (Actual): 267
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100096
      • Beijing HuiLongGuan Hospital
    • Beijing, Beijing, China, 100191
      • Peking University Sixth Hospital
    • Beijing, Beijing, China, 100088
      • Beijing Anding Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510170
      • Guangzhou Brain Hospital
  • Hebei
    • Baoding, Hebei, China, 071000
      • Hebei Province Mental Health Center
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The First Affiliated Hospital of Harbin Medical University
  • Henan
    • Xinxiang, Henan, China, 453002
      • Henan Provincial Mental Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • The Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410007
      • Hunan Province Brain Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Brain Hospital
    • Wuxi, Jiangsu, China, 214000
      • Wuxi mental health center
  • Shanghai
    • Shang Hai, Shanghai, China, 200030
      • Shanghai Mental Health Center
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • Xi'an Mental Health Center
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300222
      • Tianjin Anding Hospital
  • Yunnan
    • Kun Ming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8	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)	From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in PANSS Subscale Score at the End of Treatment	Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline	week 8
Mean Change in PANSS 5-factor Model	Mean change in PANSS 5-factor model from baseline at Week 8	Week 8
Mean Change in PANSS Symptom Scores	Mean change in PANSS symptom scores from baseline at Week 8	Week 8
Mean Change in PANSS Symptom Scores From Baseline at Each Visit	Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8	Each Visit

Collaborators and Investigators

• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
• Investigators: Principal Investigator: Niufan Gu, MD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (ESTIMATE): January 24, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Blonanserin
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: D4906011