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

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02453893

Collaborator

(none)

288

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Iloperidone Drug: Risperidone	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: oral iloperidone 2~12mg/day for 2 weeks,12~24mg/day for 6 weeks.	Drug: Iloperidone
Active Comparator: oral risperidone 1~3mg/day for 2 weeks,3~6mg/day for 6 weeks.	Drug: Risperidone

Arm

Intervention/Treatment

Experimental: oral iloperidone

2~12mg/day for 2 weeks,12~24mg/day for 6 weeks.

Drug: Iloperidone

Active Comparator: oral risperidone

1~3mg/day for 2 weeks,3~6mg/day for 6 weeks.

Drug: Risperidone

Outcome Measures

Primary Outcome Measures

the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia [8 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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。