- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00300963
Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients
February 13, 2013 updated by: GlaxoSmithKline
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
The purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.
Study Overview
Study Type
Interventional
Enrollment
275
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72201
- GSK Investigational Site
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California
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Anaheim, California, United States, 92805
- GSK Investigational Site
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Cerritos, California, United States, 90703
- GSK Investigational Site
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Garden Grove, California, United States, 92845
- GSK Investigational Site
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Glendale, California, United States, 91206
- GSK Investigational Site
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National City, California, United States, 91950
- GSK Investigational Site
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Oceanside, California, United States, 92056
- GSK Investigational Site
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Pico Rivera, California, United States, 90660
- GSK Investigational Site
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Rosemead, California, United States, 91770
- GSK Investigational Site
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San Diego, California, United States, 92123
- GSK Investigational Site
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Upland, California, United States, 91786
- GSK Investigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20016
- GSK Investigational Site
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Florida
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North Miami, Florida, United States, 33161
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30308
- GSK Investigational Site
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Missouri
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St. Louis, Missouri, United States, 63118
- GSK Investigational Site
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New Jersey
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Clementon, New Jersey, United States, 08021
- GSK Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19131
- GSK Investigational Site
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Texas
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Austin, Texas, United States, 78756
- GSK Investigational Site
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Irving, Texas, United States, 75062
- GSK Investigational Site
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Virginia
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Richmond, Virginia, United States, 23294
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
- 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 is in their first episode of schizophrenia.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
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Secondary Outcome Measures
Outcome Measure |
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The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
March 7, 2006
First Submitted That Met QC Criteria
March 7, 2006
First Posted (Estimate)
March 10, 2006
Study Record Updates
Last Update Posted (Estimate)
February 15, 2013
Last Update Submitted That Met QC Criteria
February 13, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 223412/093
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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