Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Double-blind,Double-simulation,Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02453893
• Other study ID #: CSPC-HC103/PRO/?
• Status: Recruiting
• Phase: Phase 3
• First received: May 19, 2015
• Last updated: May 26, 2015
• Start date: November 2013

Study information

• Verified date: March 2015
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Wang yu mei, master
• Phone: 86-311-67808816
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.

Description:

Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Iloperidone

• Risperidone

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia		8 weeks	No
Secondary	the score of clinical global impressions to evaluation the severity of illness		8 weeks	No
Secondary	the score of clinical global impressions to evaluation the improvement of illness		8 weeks	No