Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

NCT ID: NCT00254202

Last Updated: 2024-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

593 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-18

Study Completion Date

2007-03-21

Brief Summary

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The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Detailed Description

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Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information.

Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Conditions

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Schizophrenia

Keywords

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Schizophrenia Atypical antipsychotic Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Iloperidone

Oral iloperidone

Group Type EXPERIMENTAL

Iloperidone

Intervention Type DRUG

Ziprasidone

Oral ziprasidone

Group Type ACTIVE_COMPARATOR

Ziprasidone

Intervention Type DRUG

Placebo

Oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Iloperidone

Intervention Type DRUG

Ziprasidone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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FanaptĀ® VYV-683

Eligibility Criteria

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Inclusion Criteria

* DSM-IV diagnosis of schizophrenia
* PANSS-T of at least 70 at screening and baseline

Exclusion Criteria

* Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
* DSM-IV diagnosis of psychiatric disorder other than schizophrenia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Little Rock, Arkansas, United States

Site Status

Vanda Investigational Site

Anaheim, California, United States

Site Status

Vanda Investigational Site

Cerritos, California, United States

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Vanda Investigational Site

Garden Grove, California, United States

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Vanda Investigational Site

Glendale, California, United States

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Vanda Investigational Site

Los Angeles, California, United States

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Vanda Investigational Site

National City, California, United States

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Vanda Investigational Site

Oceanside, California, United States

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Vanda Investigational Site

Paramount, California, United States

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Vanda Investigational Site

Pico Rivera, California, United States

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Vanda Investigational Site

San Diego, California, United States

Site Status

Vanda Investigational Site

San Diego, California, United States

Site Status

Vanda Investigational Site

San Diego, California, United States

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Vanda Investigational Site

Santa Ana, California, United States

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Vanda Investigational Site

Upland, California, United States

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Vanda Investigational Site

Bradenton, Florida, United States

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Vanda Investigational Site

Fort Lauderdale, Florida, United States

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Vanda Investigational Site

Maitland, Florida, United States

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Vanda Investigational Site

Atlanta, Georgia, United States

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Vanda Investigational Site

Augusta, Georgia, United States

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Vanda Investigational Site

Hoffman Estates, Illinois, United States

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Vanda Investigational Site

Lake Charles, Louisiana, United States

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Vanda Investigational Site

Rockville, Maryland, United States

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Vanda Investigational Site

Saint Charles, Missouri, United States

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Vanda Investigational Site

St Louis, Missouri, United States

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Vanda Investigational Site

Clementon, New Jersey, United States

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Vanda Investigational Site

Brooklyn, New York, United States

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Vanda Investigational Site

Cincinnati, Ohio, United States

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Vanda Investigational Site

Philadelphia, Pennsylvania, United States

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Vanda Investigational Site

Austin, Texas, United States

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Vanda Investigational Site

Houston, Texas, United States

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Vanda Investigational Site

Irving, Texas, United States

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Vanda Investigational Site

Richmond, Virginia, United States

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Vanda Investigational Site

Tirupati, Andhra Pradesh, India

Site Status

Vanda Investigational Site

Ahmedabad, Gujarat, India

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Vanda Investigational Site

Manipal, Karnataka, India

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Vanda Investigational Site

Aurangabad, Maharashtra, India

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Vanda Investigational Site

Pune, Maharashtra, India

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Vanda Investigational Site

Jaipur, Rajasthan, India

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Vanda Investgational Site

Chennai, Tamil Nadu, India

Site Status

Vanda Investigational Site

Lucknow, Uttar Pradesh, India

Site Status

Vanda Investigational Site

Chinawaltair, Visakha Patnam, India

Site Status

Countries

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United States India

References

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Volpi S, Potkin SG, Malhotra AK, Licamele L, Lavedan C. Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia. J Clin Psychiatry. 2009 Jun;70(6):801-9. doi: 10.4088/jcp.08m04391.

Reference Type DERIVED
PMID: 19573479 (View on PubMed)

Other Identifiers

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VP-VYV-683-3101

Identifier Type: -

Identifier Source: org_study_id