Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01623713

Collaborator

(none)

260

Enrollment

Location

Arms

Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Iloperidone Efficacy	Drug: iloperidone Drug: Risperidone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Risperidone	Drug: Risperidone Risperidone is used for the treatment of schizophrenia.Risperidone is unique among most other atypicals in that it has high affinity for the D2 receptor whereas most other atypicals have 'loose binding' of the D2 receptor. It has actions at several 5-HT (serotonin) receptor subtypes.
Experimental: iloperidone	Drug: iloperidone Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.

Arm

Intervention/Treatment

Active Comparator: Risperidone

Drug: Risperidone

Risperidone is used for the treatment of schizophrenia.Risperidone is unique among most other atypicals in that it has high affinity for the D2 receptor whereas most other atypicals have 'loose binding' of the D2 receptor. It has actions at several 5-HT (serotonin) receptor subtypes.

Experimental: iloperidone

Drug: iloperidone

Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.

Outcome Measures

Primary Outcome Measures

Positive and Negative Symptom Scale(PANSS)-Total Score [6 weeks]

Secondary Outcome Measures

Effective percentage(PANSS score reduce rate≥50%) [6 weeks]
Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P) [6 weeks]
Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N) [6 weeks]
Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP) [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men or women ages 18-65 years old.
DSM-IV diagnosis of schizophrenia.
PANSS≥70.
Of the 7 PANSS positive symptom subscale, at least two score ≥ 4 points.
Written informed consent.

Exclusion Criteria:

Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
Clinically significant disease of the heart,kidneys,liver,hematonosis or endocrine system.