Schizophrenia Study In Adults - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00049946

Purpose

A Placebo Controlled Study For Patients With Schizophrenia

Condition	Intervention	Phase
Schizophrenia	Drug: talnetant Drug: risperidone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Risperidone SB 223412

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in the PANSS total score.

Secondary Outcome Measures:

Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.

Estimated Enrollment:	231
Study Start Date:	October 2002

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient must meet diagnostic criteria for schizophrenia.

Exclusion Criteria:

Patients with other psychotic disorders.
Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
Patients with a history of autistic disorder or another pervasive developmental disorder.
Patients with epilepsy or a history of seizures requiring treatment.
Patients who are excluded from taking the drug risperidone.
Patients who pose a current serious suicidal or homicidal risk.
Patients who are adequately stabilized on their treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049946

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Locations

United States, Arizona
GSK Clinical Trial Call Center
Scottsdale, Arizona, United States, 85251
United States, California
GSK Clinical Trial Call Center\
San Diego, California, United States, 92123
GSK Clinical Trial Call Center
Cerritos, California, United States, 90703
GSK Clinical Trial Call Center
Sacramento, California, United States, 95823
GSK Clinical Trial Call Center
Garden Grove, California, United States, 92845
GSK Clinical Trial Call Center
Chula Vista, California, United States, 91910
GSK Clinical Trial Call Center
Pico Rivera, California, United States, 90660
GSK Clinical Trial Call Center
Rosemead, California, United States, 91770
GSK Clinical Trial Call Center
San Diego, California, United States, 92126
GSK Clinical Trial Call Center
Orange, California, United States, 92868
United States, Connecticut
GSK Clinical Trial Call Center
New Haven, Connecticut, United States, 06519
GSK Clinical Trial Call Center
New Britain, Connecticut, United States, 06050
United States, District of Columbia
GSK Clinical Trial Call Center
Washington, District of Columbia, United States, 20016
United States, Florida
GSK Clinical Trial Call Center
Tampa, Florida, United States, 33613
GSK Clinical Trial Call Center
North Miami, Florida, United States, 33161
GSK Clinical Trial Call Center
Winter Park, Florida, United States, 32789
GSK Clinical Trial Call Center
North Miami, Florida, United States, 33161
United States, Illinois
GSK Clinical Trial Call Center
Hoffman Estates, Illinois, United States, 60194
United States, Indiana
GSK Clinical Trial Call Center
Greenwood, Indiana, United States, 46143
United States, Louisiana
GSK Clinical Trial Call Center
Shreveport, Louisiana, United States, 71101
United States, New Jersey
GSK Clinical Trial Call Center
Clementon, New Jersey, United States, 08021
United States, New York
GSK Clinical Trial Call Center
Holliswood, New York, United States, 11423
United States, North Carolina
GSK Clinical Trial Call Center
Raleigh, North Carolina, United States, 27603
GSK Clinical Trial Call Center
Butner, North Carolina, United States, 27509
United States, Ohio
GSK Clinical Trial Call Center
Cleveland, Ohio, United States, 44109
GSK Clinical Trial Call Center
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
GSK Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73103
GSK Clinical Trial Call Center
Norman, Oklahoma, United States, 73069
United States, Tennessee
GSK Clinical Trial Call Center
Nashville, Tennessee, United States, 37212
United States, Texas
GSK Clinical Trial Call Center
Austin, Texas, United States, 78729
GSK Clinical Trial Call Center
Bellaire, Texas, United States, 77401
GSK Clinical Trial Call Center
Terrell, Texas, United States, 75160

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	SB223412/078
Study First Received:	November 15, 2002
Last Updated:	April 17, 2006
ClinicalTrials.gov Identifier:	NCT00049946 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Talnetant
schizophrenia
NK3 receptor antagonist
psychosis

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents

Pharmacologic Actions
Schizophrenia
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009