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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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