A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia - Full Text View

Sponsor:	Sumitomo Pharmaceuticals America
Information provided by:	Sumitomo Pharmaceuticals America
ClinicalTrials.gov Identifier:	NCT00044044

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: SM-13496	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Lurasidone SM-13496

U.S. FDA Resources

Further study details as provided by Sumitomo Pharmaceuticals America:

Estimated Enrollment:	330
Study Start Date:	July 2002
Estimated Study Completion Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

The patient has a primary diagnosis of schizophrenia
The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
The patient has had a duration of illness of at least one year.
The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
The patient is able to remain off antipsychotic medication for a 4 day washout period

Exclusion criteria:

The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044044

Locations

United States, California
Optimum Health Services
La Mesa, California, United States, 91942
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
Institute for Psychopharmacology Research
Cerritos, California, United States, 90703
Affiliated Research Institute
San Diego, California, United States, 92108
United States, District of Columbia
Comprehensive Neuroscience. Inc.
Washington, District of Columbia, United States, 20016
United States, Florida
Comprehensive Neuroscience. Inc.
Melbourne, Florida, United States, 32935
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Carman Research
Smyrna, Georgia, United States, 30080
United States, Hawaii
Hawaii Research Center
Honolulu, Hawaii, United States, 96826
United States, Illinois
American Medical Research
Oakbrook, Illinois, United States, 60523
United States, Maryland
Centers for Behavioral Health, LLC
Rockville, Maryland, United States, 20850
United States, New Jersey
ClinSearch, Inc.
Kenilworth, New Jersey, United States, 07033
Comprehensive Clinical Research CNS, PC
Clementon, New Jersey, United States, 08021
United States, Pennsylvania
Quantum Clinical Services Group
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
FutureSearch Trials
Austin, Texas, United States, 78756
Community Clinical Research
Austin, Texas, United States, 78756
University Hills Clinical Research
Dallas, Texas, United States, 75235
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, United States, 77401
United States, Virginia
CNS, Inc.
Falls Church, Virginia, United States, 22041
United States, Washington
Northwest Clinical Research Center
Belleview, Washington, United States, 98004

Sponsors and Collaborators

Sumitomo Pharmaceuticals America

More Information

No publications provided

Study ID Numbers:	D1050049
Study First Received:	August 16, 2002
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00044044 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sumitomo Pharmaceuticals America:

Schizophrenia

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Dopamine Antagonists
Antipsychotic Agents

Pharmacologic Actions
Schizophrenia
Haloperidol
Mental Disorders
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 05, 2009