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

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder; Social Anxiety Disorder

• Registration Number: NCT00177008
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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 Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Status Verified: 2007-01
• Study Completion: 2007-01
• Last Update Submitted: 2007-01-25
• Last Update Posted: 2007-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patient does not meet DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder
2. 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.
3. Patients with acute medical conditions are not eligible.
4. Patients allergic or otherwise intolerant or non-responsive to Aripiprazole
5. Patient with history of suicidal, homicidal or assaultive plans or attempts in the past 6 months.
6. Clinically significant EKG or lab abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sheehan Disability Scale- Change from Baseline to Final Visit
Lehman Quality of Life Interview- Change from Baseline to Final Visit
Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit

Secondary Outcome Measures

Name	Time	Method
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
COSAPSQ -Change from Baseline to Final Visit
CAGE -Change from Baseline to Final Visit
Arizona sexual dysfunction scale- Change from Baseline to Final Visit
HAM-D-Change from Baseline to Final Visit
PANSS- Change from Baseline to Final Visit
Instrumental Activities of Daily Living-Change from Baseline to Final Visit

Trial Locations

Locations (1)

Robert Wood Johnson Medical School - Psychiatry Dept.; 🇺🇸 Piscataway, New Jersey, United States