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

March 10, 2016 updated by: Sunovion

A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Psychiatry Pharmaceutical
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Summit Research Group
    • California
      • Cerritos, California, United States, 90703
        • Comprehensive Neuroscience
      • Garden Grove, California, United States, 92845
        • Collaborative Neuro Science Network, Inc.
      • La Mesa, California, United States, 91942
        • Optimum Health Services
      • San Diego, California, United States, 92123
        • California Clinical Trials
      • San Diego, California, United States, 92126
        • CNRI, LLC San Diego
      • Upland, California, United States, 91786
        • Pacific Clinical Research
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Comprehensive NeuroScience, Inc
    • Florida
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
      • North Miami, Florida, United States, 33161
        • The Segal Institute
      • Tampa, Florida, United States, 33613
        • University of South Florida, Department of Psychiatry and Behavioral Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
    • Illinois
      • Hoffman Estates, Illinois, United States, 60194
        • Comprehensive NeuroScience, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Robert Lynn Horne, MD, Suite 4
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • CNS Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Quantum Clinical Services Group
    • Texas
      • Austin, Texas, United States, 78756
        • Future Search Trials
      • Austin, Texas, United States, 78729
        • Community Clinical Research
      • Bellaire, Texas, United States, 77401
        • Claghorn-Lesem Research Clinic
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
    • Virginia
      • Falls Church, Virginia, United States, 22044
        • CBH Health, L.L.C - Dominion Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching Placebo to 40mg lurasidone tablets
Experimental: Lurasidone
80 mg AM dosing once daily
Drug: Lurasidone
80 mg AM dosing once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
Baseline and 6 weeks
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
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.
Baseline and 6 weeks
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
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.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

July 30, 2004

First Submitted That Met QC Criteria

July 30, 2004

First Posted (Estimate)

August 2, 2004

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Lurasidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe