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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

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

NCT ID

NCT00177008

First Posted

September 13, 2005

Last Updated

January 25, 2007

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Bristol-Myers Squibb

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

Eligibility Criteria

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

Citation

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PubMed Identifier

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Citation

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Citation

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

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