Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Phase 2

Completed

• Conditions: Iloperidone; Efficacy; Schizophrenia
• Interventions: Drug: Risperidone; Drug: iloperidone

• Registration Number: NCT01623713
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-17
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Primary Completion: 2013-10
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-17
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risperidone	Risperidone	-
iloperidone	iloperidone	-

Primary Outcome Measures

Name	Time	Method
Positive and Negative Symptom Scale(PANSS)-Total Score	6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sixth Hospital of Peking University; 🇨🇳 Peking, Beijing, China