Clinical trial NCT01516424: Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
Official title: A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Blonanserin
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
timeFrame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.
Secondary outcomes:
measure: Mean Change in PANSS Subscale Score at the End of Treatment
timeFrame: week 8
measure: Mean Change in PANSS 5-factor Model
timeFrame: Week 8
measure: Mean Change in PANSS Symptom Scores
timeFrame: Week 8
measure: Mean Change in PANSS Symptom Scores From Baseline at Each Visit
timeFrame: Each Visit
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
city: Baoding
country: China
facility: Hebei Province Mental Health Center
state: Hebei
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Xinxiang
country: China
facility: Henan Provincial Mental Hospital
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Province Brain Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Mental Health Center
state: Jiangsu
city: Shang Hai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Mental Health Center
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
city: Kun Ming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Shanghai Mental Health Center
name: Niufan Gu, MD
role: PRINCIPAL_INVESTIGATOR
References: