A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
This study has been completed.
Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00088621
First received: July 30, 2004
Last updated: September 6, 2011
Last verified: September 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Lurasidone 80mg tablet |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Lurasidone
U.S. FDA Resources
Further study details as provided by Sunovion:
Primary Outcome Measures:
- Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 61 |
| Study Start Date: | July 2004 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lurasidone 80 mg tablet
Lurasidone 80mg oral tablet taken once a day
|
Drug: Lurasidone 80mg tablet
Other Name: Lurasidone
|
Detailed Description:
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either:
- Successfully completed
- OR
- Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088621
Locations
| United States, Alabama | |
| Birmingham Psychiatry Pharmaceutical | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arkansas | |
| Summit Research Group | |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Comprehensive NeuroScience | |
| Cerritos, California, United States, 90703 | |
| Collaborative Neuro Science Network, Inc. | |
| Garden Grove, California, United States, 92845 | |
| Optimum Health Services | |
| La Mesa, California, United States, 91942 | |
| CA Neutopsychopharmacology Clinical Research Institute (CNRI) | |
| San Diego, California, United States, 92126 | |
| California Clinical Trials | |
| San Diego, California, United States, 92123 | |
| Pacific Clinical Research | |
| Upland, California, United States, 91786 | |
| United States, District of Columbia | |
| Comprehensive NeuroScience, Inc | |
| Washington, District of Columbia, United States, 20016 | |
| United States, Florida | |
| Segal Institute for Clinical Research | |
| Fort Lauderdale, Florida, United States, 33301 | |
| Segal Institute for Clinical Research | |
| North Miami, Florida, United States, 33161 | |
| University of South Florida, Department of Psychiatry and Behavioral Medicine | |
| Tampa, Florida, United States, 33613 | |
| United States, Illinois | |
| Comprehensive Neuroscience, Inc. | |
| Hoffman Estates, Illinois, United States, 60194 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| CNS Research Institute | |
| Clementon, New Jersey, United States, 08021 | |
| United States, Pennsylvania | |
| Quantum Clinical Services Group | |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Future Search Trials | |
| Austin, Texas, United States, 78756 | |
| Community Clinical Research | |
| Austin, Texas, United States, 78729 | |
| Claghorn Lesem Research Clinic, Inc. | |
| Bellaire, Texas, United States, 77401 | |
| InSite Clinical Research | |
| DeSoto, Texas, United States, 75115 | |
| United States, Virginia | |
| CBH Health, L.L.C - Dominion Hospital | |
| Falls Church, Virginia, United States, 22044 | |
Sponsors and Collaborators
Sunovion
Investigators
| Study Director: | Medical Director, MD | Sunovion |
More Information
No publications provided
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00088621 History of Changes |
| Other Study ID Numbers: | D1050199 |
| Study First Received: | July 30, 2004 |
| Results First Received: | February 11, 2011 |
| Last Updated: | September 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sunovion:
|
Schizophrenia Latuda Lurasidone |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013