A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Lurasidone 20 mg; Drug: Lurasidone 40mg; Drug: Lurasidone 80 mg; Drug: Placebo; Drug: Haloperidol 10mg

• Registration Number: NCT00044044
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2002-08-16
• Study First Submitted QC: 2002-08-19
• Study First Posted: 2002-08-20
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Results First Submitted: 2011-02-01
• Results First Submitted QC: 2011-03-11
• Results First Posted: 2011-04-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lurasidone 20 mg	Lurasidone 20 mg	Lurasidone 20 mg tablets
Lurasidone 40 mg	Lurasidone 40mg	Lurasidone 40 mg tablets
Lurasidone 80 mg	Lurasidone 80 mg	Lurasidone 2 40 mg tablets
Placebo	Placebo	Matching Placebo to Lurasidone and Haloperidol
Haloperidol 10mg	Haloperidol 10mg	Haloperidol 10mg tablets

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. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.

Secondary Outcome Measures

Name	Time	Method
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.
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 Positive and Negative Syndrome Scale)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.

Trial Locations

Locations (33)

Alexian Brothers Behavioral Health Hospital; 🇺🇸 Hoffman Estates, Illinois, United States

ClinSearch, Inc.; 🇺🇸 Kenilworth, New Jersey, United States

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

Carman Research; 🇺🇸 Smyrna, Georgia, United States

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

University of California, Irvine; 🇺🇸 Orange, California, United States

Hawaii Research Center; 🇺🇸 Honolulu, Hawaii, United States

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

Comprehensive Clinical Research CNS, PC; 🇺🇸 Clementon, New Jersey, United States

American Medical Research; 🇺🇸 Oakbrook, Illinois, United States

Institute for Psychopharmacology Research; 🇺🇸 Cerritos, California, United States

CNS Network; 🇺🇸 Garden Grove, California, United States

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

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States

Centers for Behavioral Health, LLC; 🇺🇸 Rockville, Maryland, United States

FutureSearch Trials; 🇺🇸 Austin, Texas, United States

Affiliated Research Institute; 🇺🇸 San Diego, California, United States

Sharp Mesa Vista Hospital; 🇺🇸 San Diego, California, United States

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

Comprehensive Neuroscience. Inc.; 🇺🇸 Melbourne, Florida, United States

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

Psychiatric Professional Services Inc; 🇺🇸 Cincinnati, Ohio, United States

California Neuropsychopharmacolgoy Clinical Research Insitute; 🇺🇸 San Diego, California, United States

Coordinated Research of Florida, Inc.; 🇺🇸 Winter Park, Florida, United States

Lake Mead Hospital; 🇺🇸 North Las Vegas, Nevada, United States

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

Albert Einstein Medical Center - Dept. of Psychiatry; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Paul Medical Center; 🇺🇸 Dallas, Texas, United States

University Hills Clinical Research; 🇺🇸 Dallas, Texas, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Medstream, Inc.; 🇺🇸 Milwaukee, Wisconsin, United States

CNS, Inc.; 🇺🇸 Falls Church, Virginia, United States

Northwest Clinical Research Center; 🇺🇸 Belleview, Washington, United States