Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients
NCT ID: NCT00300963
Last Updated: 2013-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
275 participants
INTERVENTIONAL
2004-12-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Talnetant
Eligibility Criteria
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Inclusion Criteria
* Require inpatient hospitalization.
* Women may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method.
Exclusion Criteria
* Subject has other psychotic disorders or bipolar disorder.
* Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
* Subject has a recent history of substance dependence, or tests positive for illicit drug.
* Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
* Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.).
* Subject poses a current serious suicidal or homicidal risk.
* Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
* Subject has recently or is currently participating in another clinical study.
* Subject is stabilized on their current schizophrenia treatment.
* Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation).
* Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
* Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
18 Years
65 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Cerritos, California, United States
GSK Investigational Site
Garden Grove, California, United States
GSK Investigational Site
Glendale, California, United States
GSK Investigational Site
National City, California, United States
GSK Investigational Site
Oceanside, California, United States
GSK Investigational Site
Pico Rivera, California, United States
GSK Investigational Site
Rosemead, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Upland, California, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
North Miami, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Clementon, New Jersey, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Irving, Texas, United States
GSK Investigational Site
Richmond, Virginia, United States
Countries
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Other Identifiers
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223412/093
Identifier Type: -
Identifier Source: org_study_id
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