Switching to Iloperidone From Other Antipsychotics in Schizophrenia

NCT ID: NCT01207414

Last Updated: 2013-03-15

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

PHASE4

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-01-31

Brief Summary

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Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult subjects with schizophrenia who require a change in their current antipsychotic treatment of risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or safety/tolerability reasons.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iloperidone gradual switch

Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.

Group Type EXPERIMENTAL

iloperidone

Intervention Type DRUG

Iloperidone tablets supplied at doses of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to achieve a target dose of 12-24 mg/day for 12 weeks.

iloperidone immediate switch

Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.

Group Type EXPERIMENTAL

iloperidone

Intervention Type DRUG

Iloperidone tablets supplied at doses of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to achieve a target dose of 12-24 mg/day for 12 weeks.

Interventions

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iloperidone

Iloperidone tablets supplied at doses of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to achieve a target dose of 12-24 mg/day for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Fanaptâ„¢

Eligibility Criteria

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Inclusion Criteria

* Males or females, 18 to 64 years of age, inclusive
* DSM-IV diagnosis of schizophrenia
* Patients currently on an optimal in-label dose of one of the following permitted antipsychotic treatments for at least 30 days: risperidone, olanzapine, or aripiprazole
* Efficacy Clinical Global Impression of Severity (E-CGI-S) of 4 or 5 or
* Not tolerating one of the permitted treatments and exhibits one of the allowable side-effects

Exclusion Criteria

* Any other current Axis I disorder other than schizophrenia which is the focus of treatment;
* Acutely psychotic or patient's symptom severity requires hospitalization
* Patient with significant cardiovascular illness (myocardial infarction, cardiac arrhythmia)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marla Hochfeld, MD, MD

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Birmingham Psychiatry Pharmaceutical Studies, Inc.

Birmingham, Alabama, United States

Site Status

Comprehensive Neuroscience

Cerritos, California, United States

Site Status

ATP Clinical Research Center, Inc.

Costa Mesa, California, United States

Site Status

Collaborative Neuroscience Network

Garden Grove, California, United States

Site Status

Apostle Clinical Trials, Inc.

Long Beach, California, United States

Site Status

Pacific Health Systems

National City, California, United States

Site Status

Pacific Research Partners

Oakland, California, United States

Site Status

Excell Research, Inc.

Oceanside, California, United States

Site Status

University of California, Irvine

Orange, California, United States

Site Status

CNRI San Diego

San Diego, California, United States

Site Status

Affiliated Research Institute

San Diego, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

Neuropsychiatric Research Center of Orange County

Santa Ana, California, United States

Site Status

Viking Clinical Research

Temecula, California, United States

Site Status

Collaborative Neuroscience

Torrance, California, United States

Site Status

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Site Status

Comprenhensive Neuroscience

Washington D.C., District of Columbia, United States

Site Status

Amit K. Vijapura MD & Associates

Jacksonville, Florida, United States

Site Status

Scientific Clinical Research

North Miami, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Comprehensive Neuroscience

Atlanta, Georgia, United States

Site Status

Northwest Behavioral Research Center

Marietta, Georgia, United States

Site Status

Carman Research

Smyrna, Georgia, United States

Site Status

Institute for Behavioral Medicine

Smyrna, Georgia, United States

Site Status

Alexian Brothers Center for Mental Health

Arlington Heights, Illinois, United States

Site Status

Rush University Medical Center, Treatment Research Center

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

AMR - Baber Research, Inc.

Naperville, Illinois, United States

Site Status

Midwest Center for Neurobehavioral Medicine

Oakbrook Terrace, Illinois, United States

Site Status

Louisiana Clinical Research

Shreveport, Louisiana, United States

Site Status

Neurobehavioral Medicine Group, Clinical Trials Division

Bloomfield Hills, Michigan, United States

Site Status

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Site Status

Precise Research Centers

Flowood, Mississippi, United States

Site Status

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, United States

Site Status

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Site Status

CRI World Wide Clinical Research Company

Willingboro, New Jersey, United States

Site Status

Albuquerque Neuroscience

Albuquerque, New Mexico, United States

Site Status

Neurobehavioral Research

Cedarhurst, New York, United States

Site Status

Comprehensive Neuroscience

Fresh Meadows, New York, United States

Site Status

Division of Psychiatry Research - Zucker Hills Hospital

Glen Oaks, New York, United States

Site Status

Finger Lakes Clinical Research

Rochester, New York, United States

Site Status

Behavioral Medical Research

Staten Island, New York, United States

Site Status

Richmond Behavioral Associates

Staten Island, New York, United States

Site Status

North Coast Clinical Trials

Beachwood, Ohio, United States

Site Status

Neurobehavioral Clinical Research

Canton, Ohio, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, United States

Site Status

SP Research, PLLC

Oklahoma City, Oklahoma, United States

Site Status

Belmont Center for Comprehensive Treatment

Philadelphia, Pennsylvania, United States

Site Status

CRI Worldwide, LLC - Kirkbride Division

Philadelphia, Pennsylvania, United States

Site Status

Carolina Clinical Trials

Charleston, South Carolina, United States

Site Status

Community Clinical Research, Inc.

Austin, Texas, United States

Site Status

KRK Medical Research

Dallas, Texas, United States

Site Status

FutureSearch Trials

Dallas, Texas, United States

Site Status

InSite Clinical Research

DeSoto, Texas, United States

Site Status

Bayou City Research Limited

Houston, Texas, United States

Site Status

Claghorn-Lesem Research Clinic, Inc

Houston, Texas, United States

Site Status

Mary Ann Knesevich, MD, PA

Irving, Texas, United States

Site Status

InSite Clinical Research

Plano, Texas, United States

Site Status

Frontier Institute

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CILO522DUS01

Identifier Type: -

Identifier Source: org_study_id

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