Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
- Registration Number
- NCT02453893
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Brief Summary
This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.
- Detailed Description
Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 288
Inclusion Criteria
- men and women aged 18 to 65 years with schizophrenia;
- PANSS total score of at least 70 at screening and baseline;
- at least 2 more than 4 points in 7 of PANSS-P;
- informed consent.
Exclusion Criteria
- allergy with iloperidone or risperidone;
- psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment;
- any other primary Axis 1 psychiatric diagnosis;
- a history of alcohol or drug dependence in recent 1 year;
- at imminent risk of harm to self or others;
- systolic blood pressure≤90mmHg。
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description oral iloperidone Iloperidone 2\~12mg/day for 2 weeks,12\~24mg/day for 6 weeks. oral risperidone Risperidone 1\~3mg/day for 2 weeks,3\~6mg/day for 6 weeks.
- Primary Outcome Measures
Name Time Method the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia 8 weeks
- Secondary Outcome Measures
Name Time Method the score of clinical global impressions to evaluation the severity of illness 8 weeks the score of clinical global impressions to evaluation the improvement of illness 8 weeks
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China