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Schizophrenia Study In Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00049946
Recruitment Status : Completed
First Posted : November 18, 2002
Last Update Posted : August 16, 2017
Sponsor:
Information provided by:
GlaxoSmithKline

Brief Summary:
A Placebo Controlled Study For Patients With Schizophrenia

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: talnetant Drug: risperidone Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2002
Actual Primary Completion Date : April 2003
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone




Primary Outcome Measures :
  1. Change from baseline in the PANSS total score.

Secondary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049946


Locations
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United States, Arizona
GSK Clinical Trial Call Center
Scottsdale, Arizona, United States, 85251
United States, California
GSK Clinical Trial Call Center
Cerritos, California, United States, 90703
GSK Clinical Trial Call Center
Chula Vista, California, United States, 91910
GSK Clinical Trial Call Center
Garden Grove, California, United States, 92845
GSK Clinical Trial Call Center
Orange, California, United States, 92868
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
Sacramento, California, United States, 95823
GSK Clinical Trial Call Center
San Diego, California, United States, 92123
GSK Clinical Trial Call Center
San Diego, California, United States, 92126
United States, Connecticut
GSK Clinical Trial Call Center
New Britain, Connecticut, United States, 06050
GSK Clinical Trial Call Center
New Haven, Connecticut, United States, 06519
United States, District of Columbia
GSK Clinical Trial Call Center
Washington, D.C., District of Columbia, United States, 20016
United States, Florida
GSK Clinical Trial Call Center
North Miami, Florida, United States, 33161
GSK Clinical Trial Call Center
Tampa, Florida, United States, 33613
GSK Clinical Trial Call Center
Winter Park, Florida, United States, 32789
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
Hollis, New York, United States, 11423
United States, North Carolina
GSK Clinical Trial Call Center
Butner, North Carolina, United States, 27509
GSK Clinical Trial Call Center
Raleigh, North Carolina, United States, 27603
United States, Ohio
GSK Clinical Trial Call Center
Cincinnati, Ohio, United States, 45267
GSK Clinical Trial Call Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
GSK Clinical Trial Call Center
Norman, Oklahoma, United States, 73069
GSK Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73103
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
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
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ClinicalTrials.gov Identifier: NCT00049946    
Other Study ID Numbers: SB223412/078
First Posted: November 18, 2002    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Keywords provided by GlaxoSmithKline:
Talnetant
schizophrenia
NK3 receptor antagonist
psychosis
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents