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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01207414
First received: September 19, 2010
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: iloperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Adverse Events, Serious Adverse Events or Death [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

    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.


  • Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 501
Study Start Date: August 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Fanapt™

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207414

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01207414     History of Changes
Other Study ID Numbers: CILO522DUS01
Study First Received: September 19, 2010
Results First Received: December 18, 2012
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Schizophrenia
iloperidone
switch
gradual switch
immediate switch

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014