A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
SWITCHCore
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
1 other identifier
interventional
244
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 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.
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
Started Jun 2010
Shorter than P25 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
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
August 16, 2012
CompletedApril 17, 2013
April 1, 2013
11 months
June 10, 2010
May 15, 2012
April 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 Weeks
Secondary Outcomes (1)
Tolerability and Safety
6 Weeks
Study Arms (3)
Lurasidone Open-Label Arm A
EXPERIMENTALLurasidone Open-Label Arm B
EXPERIMENTALLurasidone Open-Label Arm C
EXPERIMENTALInterventions
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
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, LLC
Lake Charles, Louisiana, 70601, United States
Saint Charles Psychiatric Associates/Midwest Research Group
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 Health Sciences
Winston-Salem, North Carolina, 27157, United States
CRI Worldwide - Kirkbride Center
Philadelphia, Pennsylvania, 19131, 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, 75390-8828, United States
Wharton Research Center
Houston, Texas, 77488, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132, United States
Related Publications (2)
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.
PMID: 23473350RESULTAwad 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.
PMID: 24559217DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, CNS
- Organization
- Sunovion Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Lurasidone 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
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 14, 2010
Study Start
June 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
April 17, 2013
Results First Posted
August 16, 2012
Record last verified: 2013-04