Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
NCT ID: NCT00325689
Last Updated: 2013-11-08
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
PHASE4
323 participants
INTERVENTIONAL
2006-07-31
2007-10-31
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
Study Groups
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Quetiapine or Risperidone + Aripiprazole
Quetiapine or Risperidone + Aripiprazole
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
Quetiapine or Risperidone + placebo
Quetiapine or Risperidone + placebo
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
Interventions
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Quetiapine or Risperidone + Aripiprazole
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
Quetiapine or Risperidone + placebo
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable symptoms and dose of Quetiapine or Risperidone
Exclusion Criteria
* Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
18 Years
ALL
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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K & S Professional Research Services, Llc
Little Rock, Arkansas, United States
Comprehensive Neuroscience, Inc.
Cerritos, California, United States
Atp Clinical Research, Inc.
Costa Mesa, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
San Fernando Mental Health Center
Granada Hills, California, United States
Uci Medical Center
Orange, California, United States
California Clinical Trials Medical Group
Paramount, California, United States
California Clinical Trials
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
California Neuropsychopharmacology Clinical Research Inst.
San Diego, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Department Of Psychiatry And Behavioral Sciences
Stanford, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
University Of Colorado At Denver And Health Sciences Center
Denver, Colorado, United States
Institute Of Living
Hartford, Connecticut, United States
Behavioral Clinical Research, Inc
North Miami, Florida, United States
Uptown Research Institute, Llc
Chicago, Illinois, United States
Alexian Center For Psychiatric Research
Hoffman Estates, Illinois, United States
Indiana University School Of Medicine
Indianapolis, Indiana, United States
Lsu Health Sciences Center
Shreveport, Louisiana, United States
J. Gary Booker, Md
Shreveport, Louisiana, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
North Suffolk Mental Health Association
Boston, Massachusetts, United States
Community Counseling Of Bristol County, Inc. (Ccbc)
Taunton, Massachusetts, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Precise Research Centers
Flowood, Mississippi, United States
Cri Worldwide, Llc
Clementon, New Jersey, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Advanced Bio-Behavioral Sciences
Elmsford, New York, United States
The Zucker Hillside Hospital
Glen Oaks, New York, United States
New York State Psychiatric Institute
New York, New York, United States
Manhattan Psychiatric Center
New York, New York, United States
Strong Ties Community Support Program
Rochester, New York, United States
Behavioral Medical Research Of Staten Island
Staten Island, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Duke University Health System
Durham, North Carolina, United States
Saroj B. Brar, M.D., Inc.
Cleveland, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Department Of Veterans Affairs Medical Center
Coatesville, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Va Medical Center (116a)
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, United States
Cri Worldwide, Llc
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Medlabs Research Of Houston, Inc.
Houston, Texas, United States
University Of Texas Health Science Center At San Antonio
San Antonio, Texas, United States
Va Puget Sound Health Care System
Tacoma, Washington, United States
Countries
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References
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Kane JM, Correll CU, Goff DC, Kirkpatrick B, Marder SR, Vester-Blokland E, Sun W, Carson WH, Pikalov A, Assuncao-Talbott S. A multicenter, randomized, double-blind, placebo-controlled, 16-week study of adjunctive aripiprazole for schizophrenia or schizoaffective disorder inadequately treated with quetiapine or risperidone monotherapy. J Clin Psychiatry. 2009 Oct;70(10):1348-57. doi: 10.4088/JCP.09m05154yel.
Other Identifiers
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CN138-397 ST
Identifier Type: -
Identifier Source: org_study_id