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

NCT01516424 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2018-11-27

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Summary

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

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Sumitomo Pharma (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Niufan Gu, MD · Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01516424 on ClinicalTrials.gov