Switching to Iloperidone From Other Antipsychotics in Schizophrenia (i-FANS)
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, iloperidone, switch, gradual switch, immediate switch
Eligibility Criteria
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)
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Birmingham Psychiatry Pharmaceutical Studies, Inc.
- Comprehensive Neuroscience
- ATP Clinical Research Center, Inc.
- Collaborative Neuroscience Network
- Apostle Clinical Trials, Inc.
- Pacific Health Systems
- Pacific Research Partners
- Excell Research, Inc.
- University of California, Irvine
- CNRI San Diego
- Affiliated Research Institute
- Artemis Institute for Clinical Research
- Neuropsychiatric Research Center of Orange County
- Viking Clinical Research
- Collaborative Neuroscience
- The Hospital of Central Connecticut
- Comprenhensive Neuroscience
- Amit K. Vijapura MD & Associates
- Scientific Clinical Research
- Atlanta Center for Medical Research
- Comprehensive Neuroscience
- Northwest Behavioral Research Center
- Carman Research
- Institute for Behavioral Medicine
- Alexian Brothers Center for Mental Health
- Rush University Medical Center, Treatment Research Center
- University of Illinois at Chicago
- AMR - Baber Research, Inc.
- Midwest Center for Neurobehavioral Medicine
- Louisiana Clinical Research
- Neurobehavioral Medicine Group, Clinical Trials Division
- Rochester Center for Behavioral Medicine
- Precise Research Centers
- St. Charles Psychiatric Associates - Midwest Research Group
- Center for Emotional Fitness
- CRI World Wide Clinical Research Company
- Albuquerque Neuroscience
- Neurobehavioral Research
- Comprehensive Neuroscience
- Division of Psychiatry Research - Zucker Hills Hospital
- Finger Lakes Clinical Research
- Behavioral Medical Research
- Richmond Behavioral Associates
- North Coast Clinical Trials
- Neurobehavioral Clinical Research
- IPS Research Company
- SP Research, PLLC
- Belmont Center for Comprehensive Treatment
- CRI Worldwide, LLC - Kirkbride Division
- Carolina Clinical Trials
- Community Clinical Research, Inc.
- KRK Medical Research
- FutureSearch Trials
- InSite Clinical Research
- Bayou City Research Limited
- Claghorn-Lesem Research Clinic, Inc
- Mary Ann Knesevich, MD, PA
- InSite Clinical Research
- Frontier Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
iloperidone gradual switch
iloperidone immediate 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.
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.