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

  Show 59 Study Locations
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 August 18, 2014