Switching to Iloperidone From Other Antipsychotics in Schizophrenia
NCT ID: NCT01207414
Last Updated: 2013-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
501 participants
INTERVENTIONAL
2010-08-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Acutely psychotic or patient's symptom severity requires hospitalization
* Patient with significant cardiovascular illness (myocardial infarction, cardiac arrhythmia)
18 Years
64 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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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
Comprehensive Neuroscience
Cerritos, California, United States
ATP Clinical Research Center, Inc.
Costa Mesa, California, United States
Collaborative Neuroscience Network
Garden Grove, California, United States
Apostle Clinical Trials, Inc.
Long Beach, California, United States
Pacific Health Systems
National City, California, United States
Pacific Research Partners
Oakland, California, United States
Excell Research, Inc.
Oceanside, California, United States
University of California, Irvine
Orange, California, United States
CNRI San Diego
San Diego, California, United States
Affiliated Research Institute
San Diego, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
Viking Clinical Research
Temecula, California, United States
Collaborative Neuroscience
Torrance, California, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Comprenhensive Neuroscience
Washington D.C., District of Columbia, United States
Amit K. Vijapura MD & Associates
Jacksonville, Florida, United States
Scientific Clinical Research
North Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Comprehensive Neuroscience
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Institute for Behavioral Medicine
Smyrna, Georgia, United States
Alexian Brothers Center for Mental Health
Arlington Heights, Illinois, United States
Rush University Medical Center, Treatment Research Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
AMR - Baber Research, Inc.
Naperville, Illinois, United States
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, United States
Louisiana Clinical Research
Shreveport, Louisiana, United States
Neurobehavioral Medicine Group, Clinical Trials Division
Bloomfield Hills, Michigan, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
CRI World Wide Clinical Research Company
Willingboro, New Jersey, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, United States
Neurobehavioral Research
Cedarhurst, New York, United States
Comprehensive Neuroscience
Fresh Meadows, New York, United States
Division of Psychiatry Research - Zucker Hills Hospital
Glen Oaks, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Behavioral Medical Research
Staten Island, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
North Coast Clinical Trials
Beachwood, Ohio, United States
Neurobehavioral Clinical Research
Canton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
SP Research, PLLC
Oklahoma City, Oklahoma, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, United States
CRI Worldwide, LLC - Kirkbride Division
Philadelphia, Pennsylvania, United States
Carolina Clinical Trials
Charleston, South Carolina, United States
Community Clinical Research, Inc.
Austin, Texas, United States
KRK Medical Research
Dallas, Texas, United States
FutureSearch Trials
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Bayou City Research Limited
Houston, Texas, United States
Claghorn-Lesem Research Clinic, Inc
Houston, Texas, United States
Mary Ann Knesevich, MD, PA
Irving, Texas, United States
InSite Clinical Research
Plano, Texas, United States
Frontier Institute
Spokane, Washington, United States
Countries
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Other Identifiers
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CILO522DUS01
Identifier Type: -
Identifier Source: org_study_id
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