NCT02453893UnknownPhase 3
Double-blind,Double-simulation,Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country288 target enrollmentStarted: November 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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。
Arms & Interventions
oral iloperidone
Experimental
2~12mg/day for 2 weeks,12~24mg/day for 6 weeks.
Intervention: Iloperidone (Drug)
oral risperidone
Active Comparator
1~3mg/day for 2 weeks,3~6mg/day for 6 weeks.
Intervention: Risperidone (Drug)
Outcomes
Primary Outcomes
the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia
Time Frame: 8 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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