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Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
This study has been completed.
First Received: September 13, 2005   Last Updated: January 25, 2007   History of Changes
Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
Bristol-Myers Squibb
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00177008
  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 IV

MedlinePlus related topics: Anxiety Schizophrenia
Drug Information available for: Aripiprazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety

Further study details as provided by University of Medicine and Dentistry 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
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 New Jersey
Bristol-Myers Squibb
Investigators
Principal Investigator: Theodore Petti, MD, MPH University of Medicine and Dentistry New Jersey
Study Director: Robert Stern, MD UMDNJ-RWJMS
  More Information

Publications:
Kendler KS, Gallagher TJ, Abelson JM, Kessler RC. Lifetime prevalence, demographic risk factors, and diagnostic validity of nonaffective psychosis as assessed in a US community sample. The National Comorbidity Survey. Arch Gen Psychiatry. 1996 Nov;53(11):1022-31.
Cassano GB, Pini S, Saettoni M, Rucci P, Dell'Osso L. Occurrence and clinical correlates of psychiatric comorbidity in patients with psychotic disorders. J Clin Psychiatry. 1998 Feb;59(2):60-8.
Cosoff SJ, Hafner RJ. The prevalence of comorbid anxiety in schizophrenia, schizoaffective disorder and bipolar disorder. Aust N Z J Psychiatry. 1998 Feb;32(1):67-72.
Penn et al. (1994) Social anxiety in schizophrenia. Schizophr Res. 1994 Feb; 11(3): 277-284.
Blanchard JJ, Mueser KT, Bellack AS. Anhedonia, positive and negative affect, and social functioning in schizophrenia. Schizophr Bull. 1998;24(3):413-24.
Liebowitz MR, Social phobia. Mod Probl Pharmacopsychiatry 1987; 22:141-173.
Bobes J. How is recovery from social anxiety disorder defined? J Clin Psychiatry. 1998;59 Suppl 17:12-9. Review.
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.
Lehman AF, Ward NC, Linn LS. Chronic mental patients: the quality of life issue. Am J Psychiatry. 1982 Oct;139(10):1271-6.
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.
Lehman AF, Ward NC, Linn LS. Chronic mental patients: the quality of life issue. Am J Psychiatry. 1982 Oct;139(10):1271-6.
Jordan S, Koprivica V, Chen R, Tottori K, Kikuchi T, Altar CA. The antipsychotic aripiprazole is a potent, partial agonist at the human 5-HT1A receptor. Eur J Pharmacol. 2002 Apr 26;441(3):137-40.
Sramek JJ, Zarotsky V, Cutler NR. Generalised anxiety disorder: treatment options. Drugs. 2002;62(11):1635-48. Review.
Leslie RA. Gepirone. Organon. Curr Opin Investig Drugs. 2001 Aug;2(8):1120-7. Review.
Bourin M, Hascoet M. Drug mechanisms in anxiety. Curr Opin Investig Drugs. 2001 Feb;2(2):259-65. Review.
Mennin DS, Fresco DM, Heimberg RG, Schneier FR, Davies SO, Liebowitz MR. Screening for social anxiety disorder in the clinical setting: using the Liebowitz Social Anxiety Scale. J Anxiety Disord. 2002;16(6):661-73.

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

Keywords provided by University of Medicine and Dentistry New Jersey:
Schizophrenia
Schizoaffective Disorder
Social Anxiety Disorder

Study placed in the following topic categories:
Schizophrenia
Tranquilizing Agents
Anxiety Disorders
Mental Disorders
Psychotropic Drugs
Central Nervous System Depressants
 Psychotic Disorders
Aripiprazole
Antipsychotic Agents
Phobic Disorders
Schizophrenia and Disorders with Psychotic Features

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

ClinicalTrials.gov processed this record on May 07, 2009



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