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Status:

COMPLETED

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

Lead Sponsor:

University of Medicine and Dentistry of New Jersey

Collaborating Sponsors:

Bristol-Myers Squibb

Conditions:

Schizophrenia

Schizoaffective Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

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 anxiet...

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. T...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    January 1 2007

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00177008

    Start Date

    March 1 2004

    End Date

    January 1 2007

    Last Update

    January 29 2007

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Robert Wood Johnson Medical School - Psychiatry Dept.

    Piscataway, New Jersey, United States, 08854