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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00044044

Public ClinicalTrials.gov record NCT00044044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 25, 2026, 7:54 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms

Study identification

NCT ID
NCT00044044
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
356 participants

Conditions and interventions

Conditions

Interventions

  • Lurasidone 20 mg Drug
  • Lurasidone 40mg Drug
  • Lurasidone 80 mg Drug
  • Haloperidol 10mg Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2002
Primary completion
Apr 30, 2003
Completion
Apr 30, 2003
Last update posted
Apr 16, 2014

2002 – 2003

United States locations

U.S. sites
34
U.S. states
16
U.S. cities
29
Facility City State ZIP Site status
Birmingham Psychiatry Pharmaceutical Birmingham Alabama 35209
Institute for Psychopharmacology Research Cerritos California 90703
CNS Network Garden Grove California 92845
California Clinical Trials Medical Group Glendale California 91206
Optimum Health Services La Mesa California 91942
University of California, Irvine Orange California 92868
Affiliated Research Institute San Diego California 92108
Sharp Mesa Vista Hospital San Diego California 92123
California Neuropsychopharmacolgoy Clinical Research Insitute San Diego California 92126
Comprehensive Neuroscience. Inc. Washington D.C. District of Columbia 20016
Comprehensive Neuroscience. Inc. Melbourne Florida 32935
Segal Institute for Clinical Research North Miami Florida 33161
University of South Florida Tampa Florida 33613
Coordinated Research of Florida, Inc. Winter Park Florida 32789
Atlanta Center for Medical Research Atlanta Georgia 30308
Carman Research Smyrna Georgia 30080
Hawaii Research Center Honolulu Hawaii 96826
Alexian Brothers Behavioral Health Hospital Hoffman Estates Illinois 60194
American Medical Research Oak Brook Illinois 60523
Centers for Behavioral Health, LLC Rockville Maryland 20850
Lake Mead Hospital North Las Vegas Nevada 89030
Comprehensive Clinical Research CNS, PC Clementon New Jersey 08021
ClinSearch, Inc. Kenilworth New Jersey 07033
Psychiatric Professional Services Inc Cincinnati Ohio 45267
Quantum Clinical Services Group Philadelphia Pennsylvania 19139
Albert Einstein Medical Center - Dept. of Psychiatry Philadelphia Pennsylvania 19141
Community Clinical Research Austin Texas 78756
FutureSearch Trials Austin Texas 78756
Claghorn Lesem Research Clinic, Inc. Bellaire Texas 77401
St. Paul Medical Center Dallas Texas 75235
University Hills Clinical Research Dallas Texas 75235
CNS, Inc. Falls Church Virginia 22041
Northwest Clinical Research Center Belleview Washington 98004
Medstream, Inc. Milwaukee Wisconsin 53210

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00044044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 16, 2014 · Synced Jun 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00044044 live on ClinicalTrials.gov.

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