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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Social Anxiety Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Social Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert Wood Johnson Medical School - Psychiatry Dept.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 13, 2005
Last Updated
January 25, 2007
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00177008
Brief Title
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
Official Title
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Social Anxiety Disorder
Keywords
Schizophrenia, Schizoaffective Disorder, Social Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit
Title
Sheehan Disability Scale- Change from Baseline to Final Visit
Title
Lehman Quality of Life Interview- Change from Baseline to Final Visit
Secondary Outcome Measure Information:
Title
Instrumental Activities of Daily Living-Change from Baseline to Final Visit
Title
Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit.
Title
Ultimate game paradigm as a measure of social cohesion- Change from Baseline to Final Visit
Title
Arizona sexual dysfunction scale- Change from Baseline to Final Visit
Title
COSAPSQ -Change from Baseline to Final Visit
Title
HAM-D-Change from Baseline to Final Visit
Title
PANSS- Change from Baseline to Final Visit
Title
CAGE -Change from Baseline to Final Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Petti, MD, MPH
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Stern, MD
Organizational Affiliation
UMDNJ-RWJMS
Official's Role
Study Director
Facility Information:
Facility Name
Robert Wood Johnson Medical School - Psychiatry Dept.
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Citations:
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8911225
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Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety

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