Overview

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

Status:
Completed

Trial end date:
2007-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Medicine and Dentistry of New Jersey

Collaborator:

Bristol-Myers Squibb

Treatments:

Aripiprazole

Criteria

Inclusion Criteria

1. Patients meeting DSM IV diagnostic criteria for schizophrenia or schizoaffective
disorder.

2. 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.

3. Age 18-65

4. Gender: males or females

5. 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)

6. Good general health

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