Switching to Iloperidone From Other Antipsychotics in Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia

Interventions: Drug: iloperidone

Registration Number: NCT01207414

Lead Sponsor: Novartis

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 501

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iloperidone gradual switch	iloperidone	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.
iloperidone immediate switch	iloperidone	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.

Primary Outcome Measures

Name	Time	Method
Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12	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.
Number of Participants With Adverse Events, Serious Adverse Events or Death	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.
Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12	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.
Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12	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.
Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12	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.

Trial Locations

Locations (56): Comprehensive Neuroscience
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Fresh Meadows, New York, United States
Neuropsychiatric Research Center of Orange County
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Santa Ana, California, United States
The Hospital of Central Connecticut
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New Britain, Connecticut, United States
Behavioral Medical Research
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Staten Island, New York, United States
KRK Medical Research
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Dallas, Texas, United States
CRI World Wide Clinical Research Company
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Willingboro, New Jersey, United States
Precise Research Centers
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Flowood, Mississippi, United States
Center for Emotional Fitness
🇺🇸
Cherry Hill, New Jersey, United States
CNRI San Diego
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San Diego, California, United States
Bayou City Research Limited
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Houston, Texas, United States
Northwest Behavioral Research Center
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Marietta, Georgia, United States
Alexian Brothers Center for Mental Health
🇺🇸
Arlington Heights, Illinois, United States
Finger Lakes Clinical Research
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Rochester, New York, United States
FutureSearch Trials
🇺🇸
Dallas, Texas, United States
Neurobehavioral Research
🇺🇸
Cedarhurst, New York, United States
Institute for Behavioral Medicine
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Smyrna, Georgia, United States
Rochester Center for Behavioral Medicine
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Rochester Hills, Michigan, United States
Rush University Medical Center, Treatment Research Center
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Chicago, Illinois, United States
Carman Research
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Smyrna, Georgia, United States
Louisiana Clinical Research
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Shreveport, Louisiana, United States
University of Illinois at Chicago
🇺🇸
Chicago, Illinois, United States
AMR - Baber Research, Inc.
🇺🇸
Naperville, Illinois, United States
Neurobehavioral Medicine Group, Clinical Trials Division
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Bloomfield Hills, Michigan, United States
Midwest Center for Neurobehavioral Medicine
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Oakbrook Terrace, Illinois, United States
Albuquerque Neuroscience
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Albuquerque, New Mexico, United States
Belmont Center for Comprehensive Treatment
🇺🇸
Philadelphia, Pennsylvania, United States
InSite Clinical Research
🇺🇸
Plano, Texas, United States
Birmingham Psychiatry Pharmaceutical Studies, Inc.
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Birmingham, Alabama, United States
ATP Clinical Research Center, Inc.
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Costa Mesa, California, United States
Collaborative Neuroscience Network
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Garden Grove, California, United States
Pacific Health Systems
🇺🇸
National City, California, United States
Excell Research, Inc.
🇺🇸
Oceanside, California, United States
Affiliated Research Institute
🇺🇸
San Diego, California, United States
University of California, Irvine
🇺🇸
Orange, California, United States
Comprenhensive Neuroscience
🇺🇸
Washington, District of Columbia, United States
Viking Clinical Research
🇺🇸
Temecula, California, United States
Amit K. Vijapura MD & Associates
🇺🇸
Jacksonville, Florida, United States
St. Charles Psychiatric Associates - Midwest Research Group
🇺🇸
Saint Charles, Missouri, United States
CRI Worldwide, LLC - Kirkbride Division
🇺🇸
Philadelphia, Pennsylvania, United States
Neurobehavioral Clinical Research
🇺🇸
Canton, Ohio, United States
SP Research, PLLC
🇺🇸
Oklahoma City, Oklahoma, United States
Carolina Clinical Trials
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Charleston, South Carolina, United States
Community Clinical Research, Inc.
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Austin, Texas, United States
Mary Ann Knesevich, MD, PA
🇺🇸
Irving, Texas, United States
Claghorn-Lesem Research Clinic, Inc
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Houston, Texas, United States
Division of Psychiatry Research - Zucker Hills Hospital
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Glen Oaks, New York, United States
Collaborative Neuroscience
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Torrance, California, United States
Apostle Clinical Trials, Inc.
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Long Beach, California, United States
Scientific Clinical Research
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North Miami, Florida, United States
Artemis Institute for Clinical Research
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San Diego, California, United States
Pacific Research Partners
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Oakland, California, United States
Atlanta Center for Medical Research
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Atlanta, Georgia, United States
IPS Research Company
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Oklahoma City, Oklahoma, United States
Richmond Behavioral Associates
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Staten Island, New York, United States
North Coast Clinical Trials
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Beachwood, Ohio, United States
Frontier Institute
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Spokane, Washington, United States