A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
1 other identifier
interventional
61
1 country
21
Brief Summary
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 schizophrenia
Started Jul 2004
Shorter than P25 for phase_2 schizophrenia
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 30, 2004
CompletedFirst Posted
Study publicly available on registry
August 2, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedResults Posted
Study results publicly available
May 6, 2011
CompletedApril 17, 2014
March 1, 2014
1.3 years
July 30, 2004
February 11, 2011
March 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
1 year
Study Arms (1)
Lurasidone 80 mg tablet
EXPERIMENTALLurasidone 80mg oral tablet taken once a day
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (21)
Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, 35209, United States
Summit Research Group
Little Rock, Arkansas, 72211, United States
Comprehensive NeuroScience
Cerritos, California, 90703, United States
Collaborative Neuro Science Network, Inc.
Garden Grove, California, 92845, United States
Optimum Health Services
La Mesa, California, 91942, United States
California Clinical Trials
San Diego, California, 92123, United States
CA Neutopsychopharmacology Clinical Research Institute (CNRI)
San Diego, California, 92126, United States
Pacific Clinical Research
Upland, California, 91786, United States
Comprehensive NeuroScience, Inc
Washington D.C., District of Columbia, 20016, United States
Segal Institute for Clinical Research
Fort Lauderdale, Florida, 33301, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
University of South Florida, Department of Psychiatry and Behavioral Medicine
Tampa, Florida, 33613, United States
Comprehensive Neuroscience, Inc.
Hoffman Estates, Illinois, 60194, United States
Unknown Facility
Las Vegas, Nevada, 89102, United States
CNS Research Institute
Clementon, New Jersey, 08021, United States
Quantum Clinical Services Group
Philadelphia, Pennsylvania, 19139, United States
Community Clinical Research
Austin, Texas, 78729, United States
Future Search Trials
Austin, Texas, 78756, United States
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, 77401, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
CBH Health, L.L.C - Dominion Hospital
Falls Church, Virginia, 22044, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Josephine Cucchiaro, Executive Director
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2004
First Posted
August 2, 2004
Study Start
July 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
April 17, 2014
Results First Posted
May 6, 2011
Record last verified: 2014-03