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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00177008
First received: September 13, 2005
Last updated: January 25, 2007
Last verified: January 2007

September 13, 2005
January 25, 2007
March 2004
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00177008 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Social Anxiety Disorder
Drug: Aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2007
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177008
4680
Not Provided
Not Provided
University of Medicine and Dentistry New Jersey
Bristol-Myers Squibb
Principal Investigator: Theodore Petti, MD, MPH Rutgers, The State University of New Jersey
Study Director: Robert Stern, MD UMDNJ-RWJMS
Rutgers, The State University of New Jersey
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP