Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
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ClinicalTrials.gov Identifier: NCT00177008 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: January 29, 2007
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Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborator:
Bristol-Myers Squibb
Information provided by:
Rutgers, The State University of New Jersey
Tracking Information | |||||||
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First Submitted Date ICMJE | September 13, 2005 | ||||||
First Posted Date ICMJE | September 15, 2005 | ||||||
Last Update Posted Date | January 29, 2007 | ||||||
Study Start Date ICMJE | March 2004 | ||||||
Primary Completion Date | Not Provided | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00177008 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety | ||||||
Official Title ICMJE | Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety | ||||||
Brief Summary | This study will determine the efficacy of a medication switch to Aripiprazole for the treatment of schizophrenia or schizoaffective disorder in patients with moderate to high symptoms of social anxiety. Specifically the study will test the possibility that a medication switch to Aripiprazole reduces symptoms of social anxiety in this patient population. | ||||||
Detailed Description | Although research has shown that social anxiety is very common among patients suffering from schizophrenia or schizoaffective disorder, it is rarely diagnosed and treated in this patient population. This study will determine the efficacy of a medication switch to Aripiprazole for the treatment of schizophrenia in patients with moderate to high symptoms of social anxiety. Specifically the study will test the possibility that a medication switch to Aripiprazole reduces symptoms of social anxiety in this patient population. In addition, the study will test the possibility that Aripiprazole significantly improves social adjustment, quality of life and level of functioning in these patients. The study may also assess the ability of Aripiprazole to reduce sexual dysfunction. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 4 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Aripiprazole | ||||||
Study Arms | Not Provided | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Enrollment ICMJE |
18 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date | January 2007 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00177008 | ||||||
Other Study ID Numbers ICMJE | 4680 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | University of Medicine and Dentistry of New Jersey | ||||||
Collaborators ICMJE | Bristol-Myers Squibb | ||||||
Investigators ICMJE |
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PRS Account | Rutgers, The State University of New Jersey | ||||||
Verification Date | January 2007 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |