Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00325689
First received: May 11, 2006
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder |
Drug: Quetiapine or Risperidone + Aripiprazole Drug: Quetiapine or Risperidone + placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint [ Time Frame: (Week 16) or at time of discontinuation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S) [ Time Frame: at endpoint (Week 16) ] [ Designated as safety issue: No ]
| Enrollment: | 323 |
| Study Start Date: | July 2006 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Quetiapine or Risperidone + Aripiprazole |
Drug: 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.
Other Name: Abilify
|
| Placebo Comparator: Quetiapine or Risperidone + placebo |
Drug: Quetiapine or Risperidone + placebo
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325689
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| United States, Arkansas | |
| K & S Professional Research Services, Llc | |
| Little Rock, Arkansas, United States, 72201 | |
| United States, California | |
| Comprehensive Neuroscience, Inc. | |
| Cerritos, California, United States, 90703 | |
| Atp Clinical Research, Inc. | |
| Costa Mesa, California, United States, 92626 | |
| Collaborative Neuroscience Network, Inc. | |
| Garden Grove, California, United States, 92845 | |
| San Fernando Mental Health Center | |
| Granada Hills, California, United States, 91344 | |
| Uci Medical Center | |
| Orange, California, United States, 92868 | |
| California Clinical Trials Medical Group | |
| Paramount, California, United States, 90723 | |
| California Neuropsychopharmacology Clinical Research Inst. | |
| San Diego, California, United States, 92126 | |
| California Clinical Trials | |
| San Diego, California, United States, 92123 | |
| Sharp Mesa Vista Hospital | |
| San Diego, California, United States, 92123 | |
| Schuster Medical Research Institute | |
| Sherman Oaks, California, United States, 91403 | |
| Department Of Psychiatry And Behavioral Sciences | |
| Stanford, California, United States, 94305 | |
| Pacific Clinical Research Medical Group | |
| Upland, California, United States, 91786 | |
| United States, Colorado | |
| University Of Colorado At Denver And Health Sciences Center | |
| Denver, Colorado, United States, 80220 | |
| United States, Connecticut | |
| Institute Of Living | |
| Hartford, Connecticut, United States, 06106 | |
| United States, Florida | |
| Behavioral Clinical Research, Inc | |
| North Miami, Florida, United States, 33161 | |
| United States, Illinois | |
| Uptown Research Institute, Llc | |
| Chicago, Illinois, United States, 60640 | |
| Alexian Center For Psychiatric Research | |
| Hoffman Estates, Illinois, United States, 60194 | |
| United States, Indiana | |
| Indiana University School Of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| J. Gary Booker, Md | |
| Shreveport, Louisiana, United States, 71104 | |
| Lsu Health Sciences Center | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maryland | |
| Sheppard Pratt Health System | |
| Baltimore, Maryland, United States, 21285 | |
| United States, Massachusetts | |
| North Suffolk Mental Health Association | |
| Boston, Massachusetts, United States, 02114 | |
| Community Counseling Of Bristol County, Inc. (Ccbc) | |
| Taunton, Massachusetts, United States, 02780 | |
| United States, Minnesota | |
| University Of Minnesota | |
| Minneapolis, Minnesota, United States, 55454 | |
| United States, Mississippi | |
| Precise Research Centers | |
| Flowood, Mississippi, United States, 39232 | |
| United States, New Jersey | |
| Cri Worldwide, Llc | |
| Clementon, New Jersey, United States, 08021 | |
| United States, New York | |
| Neurobehavioral Research, Inc. | |
| Cedarhurst, New York, United States, 11516 | |
| Advanced Bio-Behavioral Sciences | |
| Elmsford, New York, United States, 10523 | |
| The Zucker Hillside Hospital | |
| Glen Oaks, New York, United States, 11004 | |
| Manhattan Psychiatric Center | |
| New York, New York, United States, 10035 | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Strong Ties Community Support Program | |
| Rochester, New York, United States, 14623 | |
| Behavioral Medical Research Of Staten Island | |
| Staten Island, New York, United States, 10305 | |
| Richmond Behavioral Associates | |
| Staten Island, New York, United States, 10312 | |
| United States, North Carolina | |
| Duke University Health System | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Saroj B. Brar, M.D., Inc. | |
| Cleveland, Ohio, United States, 44113 | |
| Midwest Clinical Research Center | |
| Dayton, Ohio, United States, 45408 | |
| United States, Pennsylvania | |
| Department Of Veterans Affairs Medical Center | |
| Coatesville, Pennsylvania, United States, 19320 | |
| Suburban Research Associates | |
| Media, Pennsylvania, United States, 19063 | |
| Belmont Center For Comprehensive Treatment | |
| Philadelphia, Pennsylvania, United States, 19131 | |
| Va Medical Center (116a) | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Cri Worldwide, Llc | |
| Philadelphia, Pennsylvania, United States, 19149 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Medlabs Research Of Houston, Inc. | |
| Houston, Texas, United States, 77057 | |
| University Of Texas Health Science Center At San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Va Puget Sound Health Care System | |
| Tacoma, Washington, United States, 98493 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
Publications:
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00325689 History of Changes |
| Other Study ID Numbers: | CN138-397 ST |
| Study First Received: | May 11, 2006 |
| Last Updated: | April 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Quetiapine Aripiprazole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 19, 2013