Back to resultsA Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents (SWITCHCore)
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lurasidone HCl
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Lurasidone, Schizophrenia, Latuda
Eligibility Criteria
Inclusion Criteria:
- Subject ≥ 18 years of age.
- Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
- Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.
Exclusion Criteria:
- Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
- Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
- Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
Sites / Locations
- K and S Professional Research Services
- Synergy Clinical Research of Escondido
- Collaborative Neuroscience Network, Inc.
- Pacific Research Partners, LLC
- California Clinical Trials
- Pasadena Research Institute
- California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
- California Neuropsychopharmacology Clinical Research Institute (CNRI)
- University of California San Diego Medical Center
- Collaborative Neuroscience Network, South Bay
- Western Affiliated Research Institute
- Comprehensive NeuroScience, Inc.
- Medical College of Georgia
- University of Illinois at Chicago
- Lake Charles Clinical Trials, LLC
- Saint Charles Psychiatric Associates/Midwest Research Group
- Neurobehavioral Research, Inc.
- The Zucker Hillside Hospital
- Duke University Dept. of Psychiatry
- Wake Forest University Health Sciences
- CRI Worldwide - Kirkbride Center
- FutureSearch Clinical Trials, LP
- FutureSearch Trials of Dallas
- Pillar Clinical Research, LLC
- University of Texas Southwestern Medical Center
- Wharton Research Center
- University of Utah Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Lurasidone Open-Label Arm A
Lurasidone Open-Label Arm B
Lurasidone Open-Label Arm C
Arm Description
Outcomes
Primary Outcome Measures
Time to Relapse of Psychotic Symptoms During 6 Weeks
Relapse is defined as any occurrence of:
Insufficient clinical response
Exacerbation of underlying disease
Discontinuation due to an adverse event
Secondary Outcome Measures
Tolerability and Safety
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events
Full Information
NCT ID
NCT01143077
First Posted
June 10, 2010
Last Updated
April 9, 2013
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01143077
Brief Title
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Acronym
SWITCHCore
Official Title
A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Lurasidone, Schizophrenia, Latuda
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lurasidone Open-Label Arm A
Arm Type
Experimental
Arm Title
Lurasidone Open-Label Arm B
Arm Type
Experimental
Arm Title
Lurasidone Open-Label Arm C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lurasidone HCl
Other Intervention Name(s)
Latuda
Intervention Description
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Primary Outcome Measure Information:
Title
Time to Relapse of Psychotic Symptoms During 6 Weeks
Description
Relapse is defined as any occurrence of:
Insufficient clinical response
Exacerbation of underlying disease
Discontinuation due to an adverse event
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Tolerability and Safety
Description
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject ≥ 18 years of age.
Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.
Exclusion Criteria:
Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lurasidone Medical Director, MD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
K and S Professional Research Services
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Synergy Clinical Research of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
California Clinical Trials
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Pasadena Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Institute (CNRI)
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8218
Country
United States
Facility Name
Collaborative Neuroscience Network, South Bay
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Western Affiliated Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Comprehensive NeuroScience, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Lake Charles Clinical Trials, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Saint Charles Psychiatric Associates/Midwest Research Group
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
Duke University Dept. of Psychiatry
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
CRI Worldwide - Kirkbride Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
FutureSearch Clinical Trials, LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
FutureSearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8828
Country
United States
Facility Name
Wharton Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77488
Country
United States
Facility Name
University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23473350
Citation
McEvoy JP, Citrome L, Hernandez D, Cucchiaro J, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study. J Clin Psychiatry. 2013 Feb;74(2):170-9. doi: 10.4088/JCP.12m07992.
Results Reference
result
PubMed Identifier
24559217
Citation
Awad G, Hassan M, Loebel A, Hsu J, Pikalov A, Rajagopalan K. Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia. BMC Psychiatry. 2014 Feb 23;14:53. doi: 10.1186/1471-244X-14-53.
Results Reference
derived
Learn more about this trial
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
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