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Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

This study is not yet open for participant recruitment.
Verified June 2012 by Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01623713
First received: June 17, 2012
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Schizophrenia
Iloperidone
Efficacy
 Drug: iloperidone
Drug: Risperidone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Jiangsu Hansoh Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Positive and Negative Symptom Scale(PANSS)-Total Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effective percentage(PANSS score reduce rate≥50%) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623713

Contacts
Contact: Lin Zhu, bachelor +86-0518-85463583 acetone_zhulin@yahoo.com.cn

Locations
China, Beijing
Sixth Hospital of Peking University Not yet recruiting
Peking, Beijing, China, 100191
Contact: Zhang     +86-010-82801940     sally_zhy@sina.com    
Sponsors and Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
  More Information

Publications:

Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01623713     History of Changes
Other Study ID Numbers: YPLT20111123
Study First Received: June 17, 2012
Last Updated: June 19, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Hansoh Pharmaceutical Co., Ltd.:
schizophrenia
iloperidone
Risperidone
Efficacy
Safety

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 22, 2013