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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Lurasidone

• Registration Number: NCT00088634
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-07-30
• Study First Submitted QC: 2004-07-30
• Study First Posted: 2004-08-02
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Results First Submitted: 2011-02-01
• Results First Submitted QC: 2011-02-03
• Results First Posted: 2011-03-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Lurasidone	Lurasidone	80 mg AM dosing once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	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.
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores	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).
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores	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.

Trial Locations

Locations (22)

Birmingham Psychiatry Pharmaceutical; 🇺🇸 Birmingham, Alabama, United States

Summit Research Group; 🇺🇸 Little Rock, Arkansas, United States

Comprehensive NeuroScience; 🇺🇸 Cerritos, California, United States

Collaborative Neuro Science Network, Inc.; 🇺🇸 Garden Grove, California, United States

Optimum Health Services; 🇺🇸 La Mesa, California, United States

California Clinical Trials; 🇺🇸 San Diego, California, United States

CNRI, LLC San Diego; 🇺🇸 San Diego, California, United States

Pacific Clinical Research; 🇺🇸 Upland, California, United States

Comprehensive NeuroScience, Inc; 🇺🇸 Washington, District of Columbia, United States

Segal Institute for Clinical Research; 🇺🇸 North Miami, Florida, United States

The Segal Institute; 🇺🇸 North Miami, Florida, United States

University of South Florida, Department of Psychiatry and Behavioral Medicine; 🇺🇸 Tampa, Florida, United States

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States

Robert Lynn Horne, MD, Suite 4; 🇺🇸 Las Vegas, Nevada, United States

Comprehensive Neuroscience, Inc.; 🇺🇸 Hoffman Estates, Illinois, United States

CNS Research Institute; 🇺🇸 Clementon, New Jersey, United States

Community Clinical Research; 🇺🇸 Austin, Texas, United States

Future Search Trials; 🇺🇸 Austin, Texas, United States

Quantum Clinical Services Group; 🇺🇸 Philadelphia, Pennsylvania, United States

Claghorn-Lesem Research Clinic; 🇺🇸 Bellaire, Texas, United States

InSite Clinical Research; 🇺🇸 DeSoto, Texas, United States

CBH Health, L.L.C - Dominion Hospital; 🇺🇸 Falls Church, Virginia, United States