A Study to Test the Effectiveness and Safety 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:
NCT00088634
First received: July 30, 2004
Last updated: September 6, 2011
Last verified: September 2011
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Purpose
A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Lurasidone Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind Fixed-dose Study Antipsychotic and Placebo 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:
- Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.
Secondary Outcome Measures:
- Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
- Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
- Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
| Enrollment: | 180 |
| Study Start Date: | May 2004 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lurasidone
80 mg AM dosing once daily
|
Drug: Lurasidone
80 mg AM dosing once daily
|
| Placebo Comparator: Placebo |
Drug: Lurasidone
Drug: Placebo
Matching Placebo to 40mg lurasidone tablets
|
Detailed Description:
Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
- The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
- If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception
Exclusion Criteria:
- The patient has used an investigational drug within the past 30 days
- The patient has participated in a previous study of this compound
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088634
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 | |
| California Clinical Trials | |
| San Diego, California, United States, 92123 | |
| CNRI, LLC San Diego | |
| San Diego, California, United States, 92126 | |
| 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 | |
| The Segal Institute | |
| North Miami, Florida, United States, 33161 | |
| 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, Georgia | |
| Atlanta Center for Medical Research | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Comprehensive Neuroscience, Inc. | |
| Hoffman Estates, Illinois, United States, 60194 | |
| United States, Nevada | |
| Robert Lynn Horne, MD, Suite 4 | |
| 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 | |
| Community Clinical Research | |
| Austin, Texas, United States, 78729 | |
| Future Search Trials | |
| Austin, Texas, United States, 78756 | |
| Claghorn-Lesem Research Clinic | |
| 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
Publications:
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00088634 History of Changes |
| Other Study ID Numbers: | D1050196 |
| Study First Received: | July 30, 2004 |
| Results First Received: | February 1, 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 May 16, 2013