Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety

Conditions
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Schizophrenia, Schizoaffective Disorder, Social Anxiety Disorder

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients meeting DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder. Patients presenting with comorbid social anxiety symptoms of moderate to high severity are eligible for participation in the study. Only patients with LSAS scores above 30* qualify for the study. Age 18-65 Gender: males or females Females: non-pregnant, not of child-bearing potential; if of child-bearing age must be on contraceptive such as pill or shot (condom alone not sufficient) Good general health Exclusion Criteria: Patient does not meet DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder Patient carries a diagnosis of dementia, degenerative CNS disorders, mental retardation, substance abuse or dependence other than nicotine dependence or alcohol abuse will be excluded from the study. Patients with acute medical conditions are not eligible. Patients allergic or otherwise intolerant or non-responsive to Aripiprazole Patient with history of suicidal, homicidal or assaultive plans or attempts in the past 6 months. Clinically significant EKG or lab abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aripiprazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit |  |  | 
| Sheehan Disability Scale- Change from Baseline to Final Visit |  |  | 
| Lehman Quality of Life Interview- Change from Baseline to Final Visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental Activities of Daily Living-Change from Baseline to Final Visit |  |  | 
| Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit. |  |  | 
| Ultimate game paradigm as a measure of social cohesion- Change from Baseline to Final Visit |  |  | 
| Arizona sexual dysfunction scale- Change from Baseline to Final Visit |  |  | 
| COSAPSQ -Change from Baseline to Final Visit |  |  | 
| HAM-D-Change from Baseline to Final Visit |  |  | 
| PANSS- Change from Baseline to Final Visit |  |  | 
| CAGE -Change from Baseline to Final Visit |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Schizoaffective Disorder, Social Anxiety Disorder