Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

NCT ID: NCT01623713

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia Iloperidone Efficacy

Keywords

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schizophrenia iloperidone Risperidone Efficacy Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Risperidone

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

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.

iloperidone

Group Type EXPERIMENTAL

iloperidone

Intervention Type DRUG

Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.

Interventions

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iloperidone

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

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sixth Hospital of Peking University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 16172203 (View on PubMed)

Other Identifiers

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YPLT20111123

Identifier Type: -

Identifier Source: org_study_id