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

November 25, 2018 updated by: Sumitomo Pharma (Suzhou) Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
267

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
Time Frame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in PANSS Subscale Score at the End of Treatment
Time Frame: week 8
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
Time Frame: Week 8
Mean change in PANSS 5-factor model from baseline at Week 8
Week 8
Mean Change in PANSS Symptom Scores
Time Frame: Week 8
Mean change in PANSS symptom scores from baseline at Week 8
Week 8
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 from baseline at week 8
Each Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sumitomo Pharma (Suzhou) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Niufan Gu, MD, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4906011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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