Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
- Conditions
- SchizophreniaSchizoaffective Disorder
- Interventions
- Registration Number
- NCT00325689
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 323
- Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
- Stable symptoms and dose of Quetiapine or Risperidone
- First diagnosis in the past year
- Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quetiapine or Risperidone + Aripiprazole Quetiapine or Risperidone + Aripiprazole - Quetiapine or Risperidone + placebo Quetiapine or Risperidone + placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (47)
Atp Clinical Research, Inc.
🇺🇸Costa Mesa, California, 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
Cri Worldwide, Llc
🇺🇸Philadelphia, Pennsylvania, United States
Belmont Center For Comprehensive Treatment
🇺🇸Philadelphia, Pennsylvania, United States
Medlabs Research Of Houston, Inc.
🇺🇸Houston, Texas, United States
University Of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Indiana University School Of Medicine
🇺🇸Indianapolis, Indiana, United States
Lsu Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Community Counseling Of Bristol County, Inc. (Ccbc)
🇺🇸Taunton, Massachusetts, United States
Institute Of Living
🇺🇸Hartford, Connecticut, United States
San Fernando Mental Health Center
🇺🇸Granada Hills, California, United States
Behavioral Medical Research Of Staten Island
🇺🇸Staten Island, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Va Medical Center (116a)
🇺🇸Philadelphia, Pennsylvania, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Saroj B. Brar, M.D., Inc.
🇺🇸Cleveland, Ohio, United States
New York State Psychiatric Institute
🇺🇸New York, New York, United States
Manhattan Psychiatric Center
🇺🇸New York, New York, 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
University Of Texas Health Science Center At San Antonio
🇺🇸San Antonio, Texas, United States
Va Puget Sound Health Care System
🇺🇸Tacoma, Washington, United States
K & S Professional Research Services, Llc
🇺🇸Little Rock, Arkansas, United States
Comprehensive Neuroscience, Inc.
🇺🇸Cerritos, California, United States
California Clinical Trials Medical Group
🇺🇸Paramount, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
Uci Medical Center
🇺🇸Orange, 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
University Of Colorado At Denver And Health Sciences Center
🇺🇸Denver, Colorado, United States
Department Of Psychiatry And Behavioral Sciences
🇺🇸Stanford, California, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Uptown Research Institute, Llc
🇺🇸Chicago, Illinois, United States
Behavioral Clinical Research, Inc
🇺🇸North Miami, Florida, United States
Alexian Center For Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Advanced Bio-Behavioral Sciences
🇺🇸Elmsford, New York, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
The Zucker Hillside Hospital
🇺🇸Glen Oaks, New York, United States
Strong Ties Community Support Program
🇺🇸Rochester, New York, United States
Duke University Health System
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States