A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
Switch Ext
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)
1 other identifier
interventional
149
1 country
27
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedResults Posted
Study results publicly available
December 17, 2012
CompletedJune 12, 2015
May 1, 2015
1.3 years
June 10, 2010
November 15, 2012
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.
6 months
Secondary Outcomes (1)
Efficacy
6 months
Study Arms (1)
Open Label
EXPERIMENTALSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
K and S Professional Research Services
Little Rock, Arkansas, 72201, United States
Synergy Clinical Research of Escondido
Escondido, California, 92025, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Pacific Research Partners, LLC
Oakland, California, 94612, United States
California Clinical Trials
Paramount, California, 90723, United States
Pasadena Research Institute
Pasadena, California, 91107, United States
California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
Pico Rivera, California, 90660, United States
California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California, 92102, United States
University of California San Diego Medical Center
San Diego, California, 92103-8218, United States
Collaborative Neuroscience Network, South Bay
Torrance, California, 90502, United States
Western Affiliated Research Institute
Denver, Colorado, 80204, United States
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, 30328, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601, United States
St. Charles Psychiatric Associates - Midwest Research
Saint Charles, Missouri, 63301, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
The Zucker Hillside Hospital
Glen Oaks, New York, 11004, United States
Duke University Dept. of Psychiatry
Durham, North Carolina, 27710, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
CRI Worldwide - Kirkbride Center
Philadelphia, Pennsylvania, 19139, United States
FutureSearch Clinical Trials, LP
Austin, Texas, 78731, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
Pillar Clinical Research, LLC
Dallas, Texas, 75243, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Wharton Research Center
Wharton, Texas, 77488, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Related Publications (2)
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.
PMID: 24330868RESULTAwad 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.
PMID: 27245981DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, CNS
- Organization
- Sunovion Pharmaceuticals Inc
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 14, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2011
Last Updated
June 12, 2015
Results First Posted
December 17, 2012
Record last verified: 2015-05