Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
1 other identifier
interventional
260
1 country
1
Brief Summary
The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 17, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 19, 2013
November 1, 2013
1.3 years
June 17, 2012
November 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive and Negative Symptom Scale(PANSS)-Total Score
6 weeks
Secondary Outcomes (4)
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
Study Arms (2)
Risperidone
ACTIVE COMPARATORiloperidone
EXPERIMENTALInterventions
Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sixth Hospital of Peking University
Beijing, Beijing Municipality, 100191, China
Related Publications (1)
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.
PMID: 16172203BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2012
First Posted
June 20, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
November 19, 2013
Record last verified: 2013-11