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

Tracking Information
First Submitted Date ICMJE	September 13, 2005
First Posted Date ICMJE	September 15, 2005
Last Update Posted Date	January 29, 2007
Study Start Date ICMJE	March 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: January 25, 2007)	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; (submitted: September 13, 2005)	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; (submitted: January 25, 2007)	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; (submitted: September 13, 2005)	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; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Schizophrenia; Schizoaffective Disorder; Social Anxiety Disorder
Intervention ICMJE	Drug: Aripiprazole
Study Arms	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; (submitted: September 13, 2005)	18
Original Enrollment ICMJE	Same as current
Study 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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