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Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Primary Purpose

Schizophrenia, Iloperidone, Efficacy

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
iloperidone
Risperidone
Sponsored by
Jiangsu Hansoh Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, iloperidone, Risperidone, Efficacy, Safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sixth Hospital of Peking University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Risperidone

iloperidone

Arm Description

Outcomes

Primary Outcome Measures

Positive and Negative Symptom Scale(PANSS)-Total Score

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2012
Last Updated
November 17, 2013
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01623713
Brief Title
Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
Official Title
A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Iloperidone, Efficacy
Keywords
schizophrenia, iloperidone, Risperidone, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risperidone
Arm Type
Active Comparator
Arm Title
iloperidone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
iloperidone
Intervention Description
Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive and Negative Symptom Scale(PANSS)-Total Score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Effective percentage(PANSS score reduce rate≥50%)
Time Frame
6 weeks
Title
Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P)
Time Frame
6 weeks
Title
Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N)
Time Frame
6 weeks
Title
Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sixth Hospital of Peking University
City
Peking
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
16172203
Citation
Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19. Erratum In: N Engl J Med. 2010 Sep 9;363(11):1092-3.
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Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

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