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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 25, 2007

Start Date ^ICMJE

March 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00177008 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 anxiety. Specifically the study will test the possibility that a medication switch to Aripiprazole reduces symptoms of social anxiety in this patient population.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder
Social Anxiety Disorder

Intervention ^ICMJE

Drug: Aripiprazole

Study Arm (s)

Not Provided

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 DL, Hope DA, Spaulding W, Kucera J. Social anxiety in schizophrenia. Schizophr Res. 1994 Feb;11(3):277-84.
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;22:141-73.
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.
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, Hascoët 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Estimated Completion Date

January 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00177008

Other Study ID Numbers ^ICMJE

4680

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Medicine and Dentistry of New Jersey

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

Principal Investigator:	Theodore Petti, MD, MPH	Rutgers, The State University of New Jersey
Study Director:	Robert Stern, MD	UMDNJ-RWJMS

Information Provided By

Rutgers, The State University of New Jersey

Verification Date

January 2007

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

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