Study Evaluating Vabicaserin in Subjects With Schizophrenia
NCT ID: NCT00563706
Last Updated: 2014-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
199 participants
INTERVENTIONAL
2007-12-31
2008-06-30
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
QUADRUPLE
Study Groups
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1
vabicaserin
This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
2
4mg/day
risperidone
3
matching placebo
placebo
Interventions
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vabicaserin
This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
risperidone
placebo
Eligibility Criteria
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Inclusion Criteria
* Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
* Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.
Exclusion Criteria
* Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
* Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.
18 Years
65 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Cerritos, California, United States
Pfizer Investigational Site
Escondido, California, United States
Pfizer Investigational Site
Garden Grove, California, United States
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Aventura, Florida, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Kissimmee, Florida, United States
Pfizer Investigational Site
Hoffman Estates, Illinois, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Lake Charles, Louisiana, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Rockville, Maryland, United States
Pfizer Investigational Site
Hamilton, New Jersey, United States
Pfizer Investigational Site
Willingboro, New Jersey, United States
Pfizer Investigational Site
Cedarhurst, New York, United States
Pfizer Investigational Site
Holliswood, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Butner, North Carolina, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Bellaire, Texas, United States
Pfizer Investigational Site
DeSoto, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Arlington, Virginia, United States
Pfizer Investigational Site
Portsmouth, Virginia, United States
Pfizer Investigational Site
Kingston, Ontario, Canada
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1911032
Identifier Type: -
Identifier Source: secondary_id
3153A1-2203
Identifier Type: -
Identifier Source: org_study_id
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