Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.
1 other identifier
interventional
323
1 country
48
Brief Summary
A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Jul 2006
Shorter than P25 for phase_4 schizophrenia
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2006
CompletedFirst Posted
Study publicly available on registry
May 15, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 8, 2013
April 1, 2011
1.3 years
May 11, 2006
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint
(Week 16) or at time of discontinuation
Secondary Outcomes (1)
Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)
at endpoint (Week 16)
Study Arms (2)
Quetiapine or Risperidone + Aripiprazole
ACTIVE COMPARATORQuetiapine or Risperidone + placebo
PLACEBO COMPARATORInterventions
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
Eligibility Criteria
You may qualify if:
- Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
- Stable symptoms and dose of Quetiapine or Risperidone
You may not qualify if:
- First diagnosis in the past year
- Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
K & S Professional Research Services, Llc
Little Rock, Arkansas, 72201, United States
Comprehensive Neuroscience, Inc.
Cerritos, California, 90703, United States
Atp Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
San Fernando Mental Health Center
Granada Hills, California, 91344, United States
Uci Medical Center
Orange, California, 92868, United States
California Clinical Trials Medical Group
Paramount, California, 90723, United States
California Clinical Trials
San Diego, California, 92123, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
California Neuropsychopharmacology Clinical Research Inst.
San Diego, California, 92126, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Department Of Psychiatry And Behavioral Sciences
Stanford, California, 94305, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
University Of Colorado At Denver And Health Sciences Center
Denver, Colorado, 80220, United States
Institute Of Living
Hartford, Connecticut, 06106, United States
Behavioral Clinical Research, Inc
North Miami, Florida, 33161, United States
Uptown Research Institute, Llc
Chicago, Illinois, 60640, United States
Alexian Center For Psychiatric Research
Hoffman Estates, Illinois, 60194, United States
Indiana University School Of Medicine
Indianapolis, Indiana, 46202, United States
Lsu Health Sciences Center
Shreveport, Louisiana, 71103, United States
J. Gary Booker, Md
Shreveport, Louisiana, 71104, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21285, United States
North Suffolk Mental Health Association
Boston, Massachusetts, 02114, United States
Community Counseling Of Bristol County, Inc. (Ccbc)
Taunton, Massachusetts, 02780, United States
University Of Minnesota
Minneapolis, Minnesota, 55454, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Cri Worldwide, Llc
Clementon, New Jersey, 08021, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Advanced Bio-Behavioral Sciences
Elmsford, New York, 10523, United States
The Zucker Hillside Hospital
Glen Oaks, New York, 11004, United States
New York State Psychiatric Institute
New York, New York, 10032, United States
Manhattan Psychiatric Center
New York, New York, 10035, United States
Strong Ties Community Support Program
Rochester, New York, 14623, United States
Behavioral Medical Research Of Staten Island
Staten Island, New York, 10305, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Duke University Health System
Durham, North Carolina, 27710, United States
Saroj B. Brar, M.D., Inc.
Cleveland, Ohio, 44113, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
Department Of Veterans Affairs Medical Center
Coatesville, Pennsylvania, 19320, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Va Medical Center (116a)
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, 19131, United States
Cri Worldwide, Llc
Philadelphia, Pennsylvania, 19149, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Medlabs Research Of Houston, Inc.
Houston, Texas, 77057, United States
University Of Texas Health Science Center At San Antonio
San Antonio, Texas, 78229, United States
Va Puget Sound Health Care System
Tacoma, Washington, 98493, United States
Related Publications (1)
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.
PMID: 19906340BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 11, 2006
First Posted
May 15, 2006
Study Start
July 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
November 8, 2013
Record last verified: 2011-04