Switching to Iloperidone From Other Antipsychotics in Schizophrenia

NCT01207414 | Completed Phase 4 Results

• 1 other identifier: CILO522DUS01
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 59

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; iloperidone; switch; gradual switch; immediate switch

Outcome Measures

Primary Outcomes (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.

  Week 12

Secondary Outcomes (5)

• Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12

  Baseline, Week 12

• Number of Participants With Adverse Events, Serious Adverse Events or Death

  12 Weeks

• Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12

  Baseline, Week 12

• Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12

  Baseline, Week 12

• Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12

  Baseline, Week 12

Study Arms (2)

iloperidone gradual switch

EXPERIMENTAL

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 immediate switch

EXPERIMENTAL

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

Interventions

iloperidone DRUG

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.

Also known as: Fanapt™

iloperidone gradual switch; iloperidone immediate switch

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis: lead

Study Sites (59)

Birmingham Psychiatry Pharmaceutical Studies, Inc.

Birmingham, Alabama, 35226, United States

Location

Comprehensive Neuroscience

Cerritos, California, 90703, United States

Location

ATP Clinical Research Center, Inc.

Costa Mesa, California, 92626, United States

Location

Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

Location

Apostle Clinical Trials, Inc.

Long Beach, California, 90813, United States

Location

Pacific Health Systems

National City, California, 91950, United States

Location

Pacific Research Partners

Oakland, California, 94612, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

CNRI San Diego

San Diego, California, 92102, United States

Location

Affiliated Research Institute

San Diego, California, 92108, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92108, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Viking Clinical Research

Temecula, California, 92591, United States

Location

Collaborative Neuroscience

Torrance, California, 90502, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06052, United States

Location

Comprenhensive Neuroscience

Washington D.C., District of Columbia, 20016, United States

Location

Amit K. Vijapura MD & Associates

Jacksonville, Florida, 32256, United States

Location

Scientific Clinical Research

North Miami, Florida, 33161, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Comprehensive Neuroscience

Atlanta, Georgia, 30328, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Institute for Behavioral Medicine

Smyrna, Georgia, 30080, United States

Location

Alexian Brothers Center for Mental Health

Arlington Heights, Illinois, 60005, United States

Location

Rush University Medical Center, Treatment Research Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

AMR - Baber Research, Inc.

Naperville, Illinois, 60563, United States

Location

Midwest Center for Neurobehavioral Medicine

Oakbrook Terrace, Illinois, 60181, United States

Location

Louisiana Clinical Research

Shreveport, Louisiana, 71115, United States

Location

Neurobehavioral Medicine Group, Clinical Trials Division

Bloomfield Hills, Michigan, 48302, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, 63301, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

CRI World Wide Clinical Research Company

Willingboro, New Jersey, 08046, United States

Location

Albuquerque Neuroscience

Albuquerque, New Mexico, 87109, United States

Location

Neurobehavioral Research

Cedarhurst, New York, 11516, United States

Location

Comprehensive Neuroscience

Fresh Meadows, New York, 11366, United States

Location

Division of Psychiatry Research - Zucker Hills Hospital

Glen Oaks, New York, 11004, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Behavioral Medical Research

Staten Island, New York, 10305, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

North Coast Clinical Trials

Beachwood, Ohio, 44122, United States

Location

Neurobehavioral Clinical Research

Canton, Ohio, 44718, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

SP Research, PLLC

Oklahoma City, Oklahoma, 73112, United States

Location

Belmont Center for Comprehensive Treatment

Philadelphia, Pennsylvania, 19131, United States

Location

CRI Worldwide, LLC - Kirkbride Division

Philadelphia, Pennsylvania, 19139, United States

Location

Carolina Clinical Trials

Charleston, South Carolina, 29407, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

KRK Medical Research

Dallas, Texas, 75230, United States

Location

FutureSearch Trials

Dallas, Texas, 75231, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Bayou City Research Limited

Houston, Texas, 77007, United States

Location

Claghorn-Lesem Research Clinic, Inc

Houston, Texas, 77008, United States

Location

Mary Ann Knesevich, MD, PA

Irving, Texas, 75062, United States

Location

InSite Clinical Research

Plano, Texas, 75074, United States

Location

Frontier Institute

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

iloperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Marla Hochfeld, MD, MD

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2010
• First Posted: September 22, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 15, 2013
• Results First Posted: March 15, 2013

Record last verified: 2013-02

Locations

US (59)