Clinical trial NCT01207414: Switching to Iloperidone From Other Antipsychotics in Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
iloperidone
switch
gradual switch
immediate switch
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-22
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Adverse Events, Serious Adverse Events or Death
timeFrame: 12 Weeks
measure: Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.
state: Alabama
city: Cerritos
country: United States
facility: Comprehensive Neuroscience
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research Center, Inc.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Long Beach
country: United States
facility: Apostle Clinical Trials, Inc.
state: California
city: National City
country: United States
facility: Pacific Health Systems
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: San Diego
country: United States
facility: CNRI San Diego
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience
state: California
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: Washington
country: United States
facility: Comprenhensive Neuroscience
state: District of Columbia
city: Jacksonville
country: United States
facility: Amit K. Vijapura MD & Associates
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Comprehensive Neuroscience
state: Georgia
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine
state: Georgia
city: Arlington Heights
country: United States
facility: Alexian Brothers Center for Mental Health
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center, Treatment Research Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Naperville
country: United States
facility: AMR - Baber Research, Inc.
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Midwest Center for Neurobehavioral Medicine
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group, Clinical Trials Division
state: Michigan
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Willingboro
country: United States
facility: CRI World Wide Clinical Research Company
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience
state: New Mexico
city: Cedarhurst
country: United States
facility: Neurobehavioral Research
state: New York
city: Fresh Meadows
country: United States
facility: Comprehensive Neuroscience
state: New York
city: Glen Oaks
country: United States
facility: Division of Psychiatry Research - Zucker Hills Hospital
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Beachwood
country: United States
facility: North Coast Clinical Trials
state: Ohio
city: Canton
country: United States
facility: Neurobehavioral Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: SP Research, PLLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Belmont Center for Comprehensive Treatment
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC - Kirkbride Division
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials
state: South Carolina
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials
state: Texas
city: Desoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Bayou City Research Limited
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Inc
state: Texas
city: Irving
country: United States
facility: Mary Ann Knesevich, MD, PA
state: Texas
city: Plano
country: United States
facility: InSite Clinical Research
state: Texas
city: Spokane
country: United States
facility: Frontier Institute
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Marla Hochfeld, MD, MD
role: STUDY_DIRECTOR
References: