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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Social Anxiety Disorder
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

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

Estimated Enrollment: 18
Study Start Date: March 2004
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177008

Locations
United States, New Jersey
Robert Wood Johnson Medical School - Psychiatry Dept.
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Bristol-Myers Squibb
Investigators
Principal Investigator: Theodore Petti, MD, MPH Rutgers, The State University of New Jersey
Study Director: Robert Stern, MD UMDNJ-RWJMS
  More Information

Publications:
Penn et al. (1994) Social anxiety in schizophrenia. Schizophr Res. 1994 Feb; 11(3): 277-284.
Liebowitz MR, Social phobia. Mod Probl Pharmacopsychiatry 1987; 22:141-173.
Stern RG, Frank D, Meraj H, Ballou S, Schnur E,: High social phobia scale scores in schizophrenia do not correlate with psychosis symptom severity scores. New Research Program and Abstracts. American Psychiatric Association 151st Annual Meeting, Washington, D.C, May 1999, NR 239.
Stern RG, Frank D, Farooq S, Beyer M,: The relationship of social anxiety to level of function over time in patients with schizophrenia. Presented at the 2002 Annual Meeting of the APA, Philadelphia, Pa.
Stern RG, Frank D, Farooq S, Beyer M: Social anxiety symptoms are common severe and unrelated to psychosis – A replication study. New Research Program and Abstracts. American Psychiatric Association 2002, Philadelphia, Pa.

ClinicalTrials.gov Identifier: NCT00177008     History of Changes
Other Study ID Numbers: 4680
Study First Received: September 13, 2005
Last Updated: January 25, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
Schizophrenia
Schizoaffective Disorder
Social Anxiety Disorder

Additional relevant MeSH terms:
Schizophrenia
Anxiety Disorders
Disease
Psychotic Disorders
Phobic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 01, 2014