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SchizophreniaPhase 4i-FANSNCT01207414

Switching to Iloperidone From Other Antipsychotics in Schizophrenia

A Phase 4 study testing iloperidone in people with Schizophrenia, run by Novartis at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Schizophrenia
What is being tested?
iloperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
501 participants
Where
59 sitesUnited States
Study dates
Aug 2010to Jan 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Albuquerque Neuroscience

    Albuquerque, New Mexico, 87109

  • Alexian Brothers Center for Mental Health

    Arlington Heights, Illinois, 60005

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Comprehensive Neuroscience

    Atlanta, Georgia, 30328

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • North Coast Clinical Trials

    Beachwood, Ohio, 44122

  • Birmingham Psychiatry Pharmaceutical Studies, Inc.

    Birmingham, Alabama, 35226

  • Neurobehavioral Medicine Group, Clinical Trials Division

    Bloomfield Hills, Michigan, 48302

  • Neurobehavioral Clinical Research

    Canton, Ohio, 44718

  • Neurobehavioral Research

    Cedarhurst, New York, 11516

  • Comprehensive Neuroscience

    Cerritos, California, 90703

  • Carolina Clinical Trials

    Charleston, South Carolina, 29407

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Rush University Medical Center, Treatment Research Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • ATP Clinical Research Center, Inc.

    Costa Mesa, California, 92626

  • KRK Medical Research

    Dallas, Texas, 75230

  • FutureSearch Trials

    Dallas, Texas, 75231

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Comprehensive Neuroscience

    Fresh Meadows, New York, 11366

  • Collaborative Neuroscience Network

    Garden Grove, California, 92845

  • Division of Psychiatry Research - Zucker Hills Hospital

    Glen Oaks, New York, 11004

  • Bayou City Research Limited

    Houston, Texas, 77007

  • Claghorn-Lesem Research Clinic, Inc

    Houston, Texas, 77008

  • Mary Ann Knesevich, MD, PA

    Irving, Texas, 75062

  • Amit K. Vijapura MD & Associates

    Jacksonville, Florida, 32256

  • Apostle Clinical Trials, Inc.

    Long Beach, California, 90813

  • Northwest Behavioral Research Center

    Marietta, Georgia, 30060

  • AMR - Baber Research, Inc.

    Naperville, Illinois, 60563

  • Pacific Health Systems

    National City, California, 91950

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06052

  • Scientific Clinical Research

    North Miami, Florida, 33161

  • Midwest Center for Neurobehavioral Medicine

    Oakbrook Terrace, Illinois, 60181

  • Pacific Research Partners

    Oakland, California, 94612

  • Excell Research, Inc.

    Oceanside, California, 92056

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • SP Research, PLLC

    Oklahoma City, Oklahoma, 73112

  • University of California, Irvine

    Orange, California, 92868

  • Belmont Center for Comprehensive Treatment

    Philadelphia, Pennsylvania, 19131

  • CRI Worldwide, LLC - Kirkbride Division

    Philadelphia, Pennsylvania, 19139

  • InSite Clinical Research

    Plano, Texas, 75074

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63301

  • CNRI San Diego

    San Diego, California, 92102

  • Affiliated Research Institute

    San Diego, California, 92108

  • Artemis Institute for Clinical Research

    San Diego, California, 92108

  • Neuropsychiatric Research Center of Orange County

    Santa Ana, California, 92701

  • Louisiana Clinical Research

    Shreveport, Louisiana, 71115

  • Carman Research

    Smyrna, Georgia, 30080

  • Institute for Behavioral Medicine

    Smyrna, Georgia, 30080

  • Frontier Institute

    Spokane, Washington, 99204

  • Behavioral Medical Research

    Staten Island, New York, 10305

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Viking Clinical Research

    Temecula, California, 92591

  • Collaborative Neuroscience

    Torrance, California, 90502

  • Comprenhensive Neuroscience

    Washington D.C., District of Columbia, 20016

  • CRI World Wide Clinical Research Company

    Willingboro, New Jersey, 08046

Other trials in United States

About this study

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

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.

Conditions
Schizophrenia
Being tested
iloperidone
Keywords
Schizophrenia, iloperidone, switch, gradual switch, immediate switch
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iloperidoneDrug

    Also called Fanapt™

    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.

Study groups in NCT01207414
Study groupRoleWhat they receive
iloperidone gradual switchExperimentalParticipants 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.
Receives: Drug: iloperidone
iloperidone immediate switchExperimentalParticipants 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.
Receives: Drug: iloperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Integrated Clinical Global Impression of Change (I-CGI-C) at 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.

    Measured: Week 12

Secondary outcomes (5)

  1. Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at 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.

    Measured: Baseline, Week 12

  2. Number of Participants With Adverse Events, Serious Adverse Events or Death

    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.

    Measured: 12 Weeks

  3. Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at 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.

    Measured: Baseline, Week 12

  4. Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at 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.

    Measured: Baseline, Week 12

  5. Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at 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.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01207414
Sponsor's protocol ID
CILO522DUS01
Acronym
i-FANS
Status last verified
Feb 2013
First submitted
19 Sep 2010
Last updated
15 Mar 2013

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing iloperidone in people with Schizophrenia, run by Novartis at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01207414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013.

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