Schizophrenia Clinical Trial
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.
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.
| Status | Completed |
| Enrollment | 323 |
| Est. completion date | October 2007 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Sheppard Pratt Health System | Baltimore | Maryland |
| United States | North Suffolk Mental Health Association | Boston | Massachusetts |
| United States | Neurobehavioral Research, Inc. | Cedarhurst | New York |
| United States | Comprehensive Neuroscience, Inc. | Cerritos | California |
| United States | Uptown Research Institute, Llc | Chicago | Illinois |
| United States | Cri Worldwide, Llc | Clementon | New Jersey |
| United States | Saroj B. Brar, M.D., Inc. | Cleveland | Ohio |
| United States | Department Of Veterans Affairs Medical Center | Coatesville | Pennsylvania |
| United States | Atp Clinical Research, Inc. | Costa Mesa | California |
| United States | Midwest Clinical Research Center | Dayton | Ohio |
| United States | University Of Colorado At Denver And Health Sciences Center | Denver | Colorado |
| United States | Duke University Health System | Durham | North Carolina |
| United States | Advanced Bio-Behavioral Sciences | Elmsford | New York |
| United States | Precise Research Centers | Flowood | Mississippi |
| United States | Collaborative Neuroscience Network, Inc. | Garden Grove | California |
| United States | The Zucker Hillside Hospital | Glen Oaks | New York |
| United States | San Fernando Mental Health Center | Granada Hills | California |
| United States | Institute Of Living | Hartford | Connecticut |
| United States | Alexian Center For Psychiatric Research | Hoffman Estates | Illinois |
| United States | Medlabs Research Of Houston, Inc. | Houston | Texas |
| United States | Indiana University School Of Medicine | Indianapolis | Indiana |
| United States | K & S Professional Research Services, Llc | Little Rock | Arkansas |
| United States | Suburban Research Associates | Media | Pennsylvania |
| United States | University Of Minnesota | Minneapolis | Minnesota |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Manhattan Psychiatric Center | New York | New York |
| United States | New York State Psychiatric Institute | New York | New York |
| United States | Behavioral Clinical Research, Inc | North Miami | Florida |
| United States | Uci Medical Center | Orange | California |
| United States | California Clinical Trials Medical Group | Paramount | California |
| United States | Belmont Center For Comprehensive Treatment | Philadelphia | Pennsylvania |
| United States | Cri Worldwide, Llc | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Va Medical Center (116a) | Philadelphia | Pennsylvania |
| United States | Strong Ties Community Support Program | Rochester | New York |
| United States | University Of Texas Health Science Center At San Antonio | San Antonio | Texas |
| United States | California Clinical Trials | San Diego | California |
| United States | California Neuropsychopharmacology Clinical Research Inst. | San Diego | California |
| United States | Sharp Mesa Vista Hospital | San Diego | California |
| United States | Schuster Medical Research Institute | Sherman Oaks | California |
| United States | J. Gary Booker, Md | Shreveport | Louisiana |
| United States | Lsu Health Sciences Center | Shreveport | Louisiana |
| United States | Department Of Psychiatry And Behavioral Sciences | Stanford | 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 Puget Sound Health Care System | Tacoma | Washington |
| United States | Community Counseling Of Bristol County, Inc. (Ccbc) | Taunton | Massachusetts |
| United States | Pacific Clinical Research Medical Group | Upland | California |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka America Pharmaceutical |
United States,
Kane JM, Correll CU, Goff DC, Kirkpatrick B, Marder SR, Vester-Blokland E, Sun W, Carson WH, Pikalov A, Assunção-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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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) | No |
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