Status:

COMPLETED

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

Lead Sponsor:

Sumitomo Pharma (Suzhou) Co., Ltd.

Conditions:

Schizophrenia

Eligibility:

All Genders

18-64 years

Phase:

PHASE3

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: * ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2013

Estimated Enrollment :

267 Patients enrolled

Trial Details

Trial ID

NCT01516424

Start Date

February 1 2012

End Date

February 1 2013

Last Update

November 27 2018

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Beijing Anding Hospital

Beijing, Beijing Municipality, China, 100088

2

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, China, 100096

3

Peking University Sixth Hospital

Beijing, Beijing Municipality, China, 100191

4

Guangzhou Brain Hospital

Guangzhou, Guangdong, China, 510170