Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
- Registration Number
- NCT01516424
- Lead Sponsor
- Sumitomo Pharma (Suzhou) Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blonanserin Blonanserin Antipsychotics Risperidone Risperidone Antipsychotics
- Primary Outcome Measures
Name Time Method Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 From baseline to the end of study、week 8(day 56)or before other antipsychotic taken. Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores\<70 is the normal,but the scores\>120 is more serious.Change=(Week 8 Score - Baseline score)
- Secondary Outcome Measures
Name Time Method Mean Change in PANSS Subscale Score at the End of Treatment week 8 Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline
Mean Change in PANSS 5-factor Model Week 8 Mean change in PANSS 5-factor model from baseline at Week 8
Mean Change in PANSS Symptom Scores Week 8 Mean change in PANSS symptom scores from baseline at Week 8
Mean Change in PANSS Symptom Scores From Baseline at Each Visit Each Visit Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8
Trial Locations
- Locations (16)
Peking University Sixth Hospital
🇨🇳Beijing, Beijing, China
Henan Provincial Mental Hospital
🇨🇳Xinxiang, Henan, China
Hunan Province Brain Hospital
🇨🇳Changsha, Hunan, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China
Xi'an Mental Health Center
🇨🇳Xi'an, Shanxi, China
Wuxi Mental Health Center
🇨🇳Wuxi, Jiangsu, China
Shanghai Mental Health Center
🇨🇳Shang Hai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Anding Hospital
🇨🇳Tianjin, Tianjin, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kun Ming, Yunnan, China
Beijing Anding Hospital
🇨🇳Beijing, Beijing, China
Beijing Huilongguan Hospital
🇨🇳Beijing, Beijing, China
Guangzhou Brain Hospital
🇨🇳Guangzhou, Guangdong, China
Hebei Province Mental Health Center
🇨🇳Baoding, Hebei, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China