Clinical trial NCT00325689: Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2006-05-15
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
* Stable symptoms and dose of Quetiapine or Risperidone

Exclusion Criteria:

* First diagnosis in the past year
* Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse

Primary outcomes:
measure: Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint
timeFrame: (Week 16) or at time of discontinuation
Secondary outcomes:
measure: Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)
timeFrame: at endpoint (Week 16)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K & S Professional Research Services, Llc
state: Arkansas
city: Cerritos
country: United States
facility: Comprehensive Neuroscience, Inc.
state: California
city: Costa Mesa
country: United States
facility: Atp Clinical Research, Inc.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Granada Hills
country: United States
facility: San Fernando Mental Health Center
state: California
city: Orange
country: United States
facility: Uci Medical Center
state: California
city: Paramount
country: United States
facility: California Clinical Trials Medical Group
state: California
city: San Diego
country: United States
facility: California Clinical Trials
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Inst.
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Stanford
country: United States
facility: Department Of Psychiatry And Behavioral Sciences
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Denver
country: United States
facility: University Of Colorado At Denver And Health Sciences Center
state: Colorado
city: Hartford
country: United States
facility: Institute Of Living
state: Connecticut
city: North Miami
country: United States
facility: Behavioral Clinical Research, Inc
state: Florida
city: Chicago
country: United States
facility: Uptown Research Institute, Llc
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Center For Psychiatric Research
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School Of Medicine
state: Indiana
city: Shreveport
country: United States
facility: Lsu Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: J. Gary Booker, Md
state: Louisiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Boston
country: United States
facility: North Suffolk Mental Health Association
state: Massachusetts
city: Taunton
country: United States
facility: Community Counseling Of Bristol County, Inc. (Ccbc)
state: Massachusetts
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Clementon
country: United States
facility: Cri Worldwide, Llc
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Elmsford
country: United States
facility: Advanced Bio-Behavioral Sciences
state: New York
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: New York
country: United States
facility: Manhattan Psychiatric Center
state: New York
city: Rochester
country: United States
facility: Strong Ties Community Support Program
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research Of Staten Island
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Cleveland
country: United States
facility: Saroj B. Brar, M.D., Inc.
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Coatesville
country: United States
facility: Department Of Veterans Affairs Medical Center
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Va Medical Center (116a)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center For Comprehensive Treatment
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cri Worldwide, Llc
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Medlabs Research Of Houston, Inc.
state: Texas
city: San Antonio
country: United States
facility: University Of Texas Health Science Center At San Antonio
state: Texas
city: Tacoma
country: United States
facility: Va Puget Sound Health Care System
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.