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

Sumitomo Pharma

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Blonanserin

Drug: Risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01516424

D4906011

Details and patient eligibility

About

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

Full 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

Enrollment

267 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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