Switching to Iloperidone From Other Antipsychotics in Schizophrenia

Schizophrenia Clinical Trial

— i-FANS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207414
• Other study ID #: CILO522DUS01
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2010
• Last updated: February 4, 2013
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Albuquerque Neuroscience	Albuquerque	New Mexico
United States	Alexian Brothers Center for Mental Health	Arlington Heights	Illinois
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Comprehensive Neuroscience	Atlanta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	North Coast Clinical Trials	Beachwood	Ohio
United States	Birmingham Psychiatry Pharmaceutical Studies, Inc.	Birmingham	Alabama
United States	Neurobehavioral Medicine Group, Clinical Trials Division	Bloomfield Hills	Michigan
United States	Neurobehavioral Clinical Research	Canton	Ohio
United States	Neurobehavioral Research	Cedarhurst	New York
United States	Comprehensive Neuroscience	Cerritos	California
United States	Carolina Clinical Trials	Charleston	South Carolina
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Rush University Medical Center, Treatment Research Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	ATP Clinical Research Center, Inc.	Costa Mesa	California
United States	FutureSearch Trials	Dallas	Texas
United States	KRK Medical Research	Dallas	Texas
United States	InSite Clinical Research	Desoto	Texas
United States	Precise Research Centers	Flowood	Mississippi
United States	Comprehensive Neuroscience	Fresh Meadows	New York
United States	Collaborative Neuroscience Network	Garden Grove	California
United States	Division of Psychiatry Research - Zucker Hills Hospital	Glen Oaks	New York
United States	Bayou City Research Limited	Houston	Texas
United States	Claghorn-Lesem Research Clinic, Inc	Houston	Texas
United States	Mary Ann Knesevich, MD, PA	Irving	Texas
United States	Amit K. Vijapura MD & Associates	Jacksonville	Florida
United States	Apostle Clinical Trials, Inc.	Long Beach	California
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	AMR - Baber Research, Inc.	Naperville	Illinois
United States	Pacific Health Systems	National City	California
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Scientific Clinical Research	North Miami	Florida
United States	Midwest Center for Neurobehavioral Medicine	Oakbrook Terrace	Illinois
United States	Pacific Research Partners	Oakland	California
United States	Excell Research, Inc.	Oceanside	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	SP Research, PLLC	Oklahoma City	Oklahoma
United States	University of California, Irvine	Orange	California
United States	Belmont Center for Comprehensive Treatment	Philadelphia	Pennsylvania
United States	CRI Worldwide, LLC - Kirkbride Division	Philadelphia	Pennsylvania
United States	InSite Clinical Research	Plano	Texas
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri
United States	Affiliated Research Institute	San Diego	California
United States	Artemis Institute for Clinical Research	San Diego	California
United States	CNRI San Diego	San Diego	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	Louisiana Clinical Research	Shreveport	Louisiana
United States	Carman Research	Smyrna	Georgia
United States	Institute for Behavioral Medicine	Smyrna	Georgia
United States	Frontier Institute	Spokane	Washington
United States	Behavioral Medical Research	Staten Island	New York
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Viking Clinical Research	Temecula	California
United States	Collaborative Neuroscience	Torrance	California
United States	Comprenhensive Neuroscience	Washington	District of Columbia
United States	CRI World Wide Clinical Research Company	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12	No
Secondary	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.	Baseline, Week 12	No
Secondary	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.	12 Weeks	Yes
Secondary	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.	Baseline, Week 12	No
Secondary	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.	Baseline, Week 12	No
Secondary	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.	Baseline, Week 12	No