Back to resultsA Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Switch Ext)
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 Schizophrenia, Lurasidone, Latuda
Eligibility Criteria
Inclusion Criteria:
- Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).
Exclusion Criteria:
- Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
- Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).
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
- St. Charles Psychiatric Associates - Midwest Research
- Neurobehavioral Research, Inc.
- The Zucker Hillside Hospital
- Duke University Dept. of Psychiatry
- Wake Forest University Baptist Medical Center
- 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 School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label
Arm Description
Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study.
Outcomes
Primary Outcome Measures
Adverse Events
Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.
Secondary Outcome Measures
Efficacy
Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289
Full Information
NCT ID
NCT01143090
First Posted
June 10, 2010
Last Updated
May 19, 2015
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01143090
Brief Title
A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
Acronym
Switch Ext
Official Title
A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)
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 purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Lurasidone, Latuda
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label
Arm Type
Experimental
Arm Description
Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study.
Intervention Type
Drug
Intervention Name(s)
Lurasidone HCl
Intervention Description
40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months
Primary Outcome Measure Information:
Title
Adverse Events
Description
Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy
Description
Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).
Exclusion Criteria:
Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
St. Charles Psychiatric Associates - Midwest Research
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 Baptist Medical Center
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
19139
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
Country
United States
Facility Name
Wharton Research Center
City
Wharton
State/Province
Texas
ZIP/Postal Code
77488
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24330868
Citation
Citrome L, Weiden PJ, McEvoy JP, Correll CU, Cucchiaro J, Hsu J, Loebel A. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study. CNS Spectr. 2014 Aug;19(4):330-9. doi: 10.1017/S109285291300093X. Epub 2013 Dec 16.
Results Reference
result
PubMed Identifier
27245981
Citation
Awad G, Ng-Mak D, Rajagopalan K, Hsu J, Pikalov A, Loebel A. Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia. BMC Psychiatry. 2016 Jun 1;16:176. doi: 10.1186/s12888-016-0879-5.
Results Reference
derived
Learn more about this trial
A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
We'll reach out to this number within 24 hrs