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

NCT ID: NCT01516424

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-02-28

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

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

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Blonanserin

Antipsychotics

Group Type: EXPERIMENTAL

Blonanserin

Intervention Type: DRUG

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.

Risperidone

Antipsychotics

Group Type: ACTIVE_COMPARATOR

Risperidone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lonasen; Risperdal

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niufan Gu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Beijing Anding Hospital

Beijing, Beijing Municipality, China

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, China

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Guangzhou Brain Hospital

Guangzhou, Guangdong, China

Hebei Province Mental Health Center

Baoding, Hebei, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Henan Provincial Mental Hospital

Xinxiang, Henan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Hunan Province Brain Hospital

Changsha, Hunan, China

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Wuxi Mental Health Center

Wuxi, Jiangsu, China

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Xi'an Mental Health Center

Xi’an, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Countries

China

Other Identifiers

D4906011

Identifier Type: -

Identifier Source: org_study_id