A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00088634
First received: July 30, 2004
Last updated: March 31, 2014
Last verified: March 2014
  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 of SM-13496 and Placebo in the Treatment of Schizophrenia

Resource links provided by NLM:


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: 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: March 31, 2014
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 April 17, 2014