Switching to Iloperidone From Other Antipsychotics in Schizophrenia (i-FANS)

February 4, 2013 updated by: Novartis

A 12-week, Randomized, Multi-center, Open-Label, Iloperidone, (12-24 mg/Day), Flexible Dose Study Assessing Efficacy, Safety and Tolerability of Two Switch Approaches in Schizophrenia Patients Currently Receiving Risperidone, Olanzapine or Aripiprazole

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35226
        • Birmingham Psychiatry Pharmaceutical Studies, Inc.
    • California
      • Cerritos, California, United States, 90703
        • Comprehensive Neuroscience
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research Center, Inc.
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network
      • Long Beach, California, United States, 90813
        • Apostle Clinical Trials, Inc.
      • National City, California, United States, 91950
        • Pacific Health Systems
      • Oakland, California, United States, 94612
        • Pacific Research Partners
      • Oceanside, California, United States, 92056
        • Excell Research, Inc.
      • Orange, California, United States, 92868
        • University of California, Irvine
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • San Diego, California, United States, 92102
        • CNRI San Diego
      • San Diego, California, United States, 92108
        • Artemis Institute for Clinical Research
      • Santa Ana, California, United States, 92701
        • Neuropsychiatric Research Center of Orange County
      • Temecula, California, United States, 92591
        • Viking Clinical Research
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience
    • Connecticut
      • New Britain, Connecticut, United States, 06052
        • The Hospital of Central Connecticut
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Comprenhensive Neuroscience
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Amit K. Vijapura MD & Associates
      • North Miami, Florida, United States, 33161
        • Scientific Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30328
        • Comprehensive Neuroscience
      • Marietta, Georgia, United States, 30060
        • Northwest Behavioral Research Center
      • Smyrna, Georgia, United States, 30080
        • Institute For Behavioral Medicine
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Alexian Brothers Center for Mental Health
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center, Treatment Research Center
      • Naperville, Illinois, United States, 60563
        • AMR - Baber Research, Inc.
      • Oakbrook Terrace, Illinois, United States, 60181
        • Midwest Center for Neurobehavioral Medicine
    • Louisiana
      • Shreveport, Louisiana, United States, 71115
        • Louisiana Clinical Research
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Neurobehavioral Medicine Group, Clinical Trials Division
      • Rochester Hills, Michigan, United States, 48307
        • Rochester Center for Behavioral Medicine
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • St. Charles Psychiatric Associates - Midwest Research Group
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Center For Emotional Fitness
      • Willingboro, New Jersey, United States, 08046
        • CRI World Wide Clinical Research Company
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research
      • Fresh Meadows, New York, United States, 11366
        • Comprehensive Neuroscience
      • Glen Oaks, New York, United States, 11004
        • Division of Psychiatry Research - Zucker Hills Hospital
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • North Coast Clinical Trials
      • Canton, Ohio, United States, 44718
        • Neurobehavioral Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
      • Oklahoma City, Oklahoma, United States, 73112
        • SP Research, PLLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19131
        • Belmont Center For Comprehensive Treatment
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide, LLC - Kirkbride Division
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Carolina Clinical Trials
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials
      • Dallas, Texas, United States, 75230
        • KRK Medical Research
      • Desoto, Texas, United States, 75115
        • InSite Clinical Research
      • Houston, Texas, United States, 77007
        • Bayou City Research Limited
      • Houston, Texas, United States, 77008
        • Claghorn-Lesem Research Clinic, Inc
      • Irving, Texas, United States, 75062
        • Mary Ann Knesevich, MD, PA
      • Plano, Texas, United States, 75074
        • InSite Clinical Research
    • Washington
      • Spokane, Washington, United States, 99204
        • Frontier Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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 Names:
  • Fanapt™
Experimental: 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.
Drug: 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 Names:
  • Fanapt™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12
Time Frame: Week 12
The I-CGI-C at Week 12 was the overall impression of medically qualified raters using three separate Clinical Global Impression of Change scales: efficacy (E-CGI-C); safety and tolerability (ST-CGI-S); and overall severity (I-CGI-S) combined for a total score. The I-CGI-C scale ranged from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12
Time Frame: Baseline, Week 12
The TSQM consisted of 14 questions about the patient's satisfaction with the drug in 4 domains: Effectiveness [3 questions scored as 1(extremely dissatisfied) to 7(extremely satisfied)], Side Effects [question 4 scored as 0(no) or 1(yes);question 5 scored as 1(extremely bothersome) to 5(not at all bothersome);questions 6 - 8 scored as 1(a great deal) to 5(not at all)], Convenience [questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy);question 11 scored as 1(extremely inconvenient) to 5 (extremely convenient)] and Global Satisfaction [question 12 scored as 1(not at all confident) to 7(extremely confident);question 13 scored as 1(not at all certain) to 5(extremely certain);question 14 scored as 1(extremely dissatisfied) to 5(extremely satisfied)]. The scores of each of the domains were added together and an algorithm used to create a score of 0 to 100. Higher scores for each domain indicate a better outcome. A positive change from baseline indicates improvement.
Baseline, Week 12
Number of Participants With Adverse Events, Serious Adverse Events or Death
Time Frame: 12 Weeks

Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen.

Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.

Additional information about adverse events can be found in the Adverse Event section.
12 Weeks
Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12
Time Frame: Baseline, Week 12
Medically qualified raters use the E-CGI-S scale at Baseline and Week 12 to assess the effectiveness of treatment by examining changes in positive symptoms [hallucinations (false perceptions), delusions (false beliefs), paranoia (unfounded distrust), conceptual disorganization (loosening of associations), or hostility], negative symptoms [apathy (lack of interest), avolition (lack of motivation), alogia (poverty of speech), and anhedonia (absence of pleasure)] and cognitive symptoms [concentration difficulties, difficulties with executive function (integrative reasoning), and illogical thinking] in the previous 7 days on a scale of 1 to 7 (1=normal, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill or 7=among the most extremely ill). A negative change from baseline indicates improvement.
Baseline, Week 12
Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12
Time Frame: Baseline, Week 12
Medically qualified raters used the ST-CGI-S at Baseline and Week 12 to evaluate safety and tolerability in the previous 7 days on a scale of 1 to 7 (1=Normal-no symptoms, 2=borderline severity, 3=mild impairment, 4=moderate, 5=marked, 6=severe, 7=among the most severe.) A negative change from baseline indicates improvement.
Baseline, Week 12
Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12
Time Frame: Baseline, Week 12
I-CGI-S incorporated the overall, combined impression of illness severity based upon the E-CGI-S and ST-CGI-S. Medically qualified raters evaluated the patient's illness in the previous 7 days at Baseline and Week 12 on a scale of 1 to 7 (1=normal not at all ill, 2=borderline mental illness or impairment, 3=mildly ill or impaired, 4=moderately ill or impaired, 5=marked ill or impaired, 6= severely ill or impaired or 7=among the most extremely ill patients. A negative change from baseline indicates improvement.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Marla Hochfeld, MD, MD, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 19, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CILO522DUS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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