An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
NCT ID: NCT01175135
Last Updated: 2018-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
259 participants
INTERVENTIONAL
2010-10-31
2011-08-31
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
Study Groups
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PF-02545920 5 mg
PF-02545920
5 mg tablet every 12 hours for 28 days
PF-02545920 15 mg
PF-02545920
15 mg tablet every 12 hours for 28 days
Placebo
Placebo
One tablet/capsule every 12 hours for 28 days
Risperidone 3 mg
Risperidone
3 mg capsule every 12 hours for 28 days
Interventions
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PF-02545920
5 mg tablet every 12 hours for 28 days
PF-02545920
15 mg tablet every 12 hours for 28 days
Placebo
One tablet/capsule every 12 hours for 28 days
Risperidone
3 mg capsule every 12 hours for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.
Exclusion Criteria
* Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
* Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.
18 Years
65 Years
ALL
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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K & S Professional Research Services, LLC
Little Rock, Arkansas, United States
Leisure Court Center
Anaheim, California, United States
Early Phase Investigational Center
Escondido, California, United States
Synergy Clinical Research Center of Escondido
Escondido, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Ocean View Psychiatric Health Facility
Long Beach, California, United States
Long Beach VA Healthcare System
Long Beach, California, United States
University of California Irvine Medical Center
Orange, California, United States
California Clinical Trials Medical Group
Paramount, California, United States
LaPaz Geropsychiatric Center
Paramount, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
Collaborative Neuroscience Network, Inc.
Torrance, California, United States
Del Amo Hospital
Torrance, California, United States
Comprehensive Neuroscience, Incorporated
Washington D.C., District of Columbia, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Lakeside Behavioral Healthcare
Orlando, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Chinmay K. Patel, D.O.
Hoffman Estates, Illinois, United States
Lake Charles Memorial Hospital
Lake Charles, Louisiana, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
CBH Health, LLC
Rockville, Maryland, United States
St. Louis Clinical Trials, LC
St Louis, Missouri, United States
CRI Worldwide, LLC
Willingboro, New Jersey, United States
Lourdes Medical Center of Burlington County
Willingboro, New Jersey, United States
Comprehensive Neuroscience, Inc.
Hollis, New York, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
FutureSearch Trials
Austin, Texas, United States
TexasNeuroRehab Center
Austin, Texas, United States
Community Clinical Research
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Behavioral Hospital - Bellaire
Houston, Texas, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Fairfax Hospital
Kirkland, Washington, United States
Zentralinstitut fuer Seelische Gesundheit
Mannheim, , Germany
Municipal Establishment "Dnipropetrovsk Regional Clinical Hospital n.a. Mechnikov"
Dnipropetrovsk, , Ukraine
Municipal Establishment "Dnipropetrovsk Regional Clinical Psychiatric Hospital"
Dnipropetrovsk, , Ukraine
Kyiv City Psychoneurological Hospital #2
Kyiv, , Ukraine
Kyiv City Clinical Psychoneurological Hospital #1
Kyiv, , Ukraine
Lugansk Regional Clinical Psychoneurological Hospital
Luhansk, , Ukraine
Poltava Regional Clinical Psychiatric Hospital n.a. O.F. Maltsev
Poltava, , Ukraine
Kherson Regional Psychiatric Hospital, Department #3
Stepanivka, Kherson, , Ukraine
Countries
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References
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Targum SD, Little JA, Lopez E, Demartinis N, Rapaport M, Ereshefsky L. Application of external review for subject selection in a schizophrenia trial. J Clin Psychopharmacol. 2012 Apr;32(2):825-6. doi: 10.1097/JCP.0b013e318248da90. No abstract available.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-020764-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8241012
Identifier Type: -
Identifier Source: org_study_id
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