Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

November 17, 2013 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100191
        • Sixth Hospital of Peking University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive and Negative Symptom Scale(PANSS)-Total Score
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

June 17, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (ESTIMATE)

June 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 17, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YPLT20111123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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