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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177008
• Other study ID #: 4680
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 25, 2007
• Start date: March 2004
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobic Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Social Anxiety Disorder

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
United States	Robert Wood Johnson Medical School - Psychiatry Dept.	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (16)

Blanchard JJ, Mueser KT, Bellack AS. Anhedonia, positive and negative affect, and social functioning in schizophrenia. Schizophr Bull. 1998;24(3):413-24. — View Citation

Bobes J. How is recovery from social anxiety disorder defined? J Clin Psychiatry. 1998;59 Suppl 17:12-9. Review. — View Citation

Bourin M, Hascoët M. Drug mechanisms in anxiety. Curr Opin Investig Drugs. 2001 Feb;2(2):259-65. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lehman AF, Ward NC, Linn LS. Chronic mental patients: the quality of life issue. Am J Psychiatry. 1982 Oct;139(10):1271-6. — View Citation

Leslie RA. Gepirone. Organon. Curr Opin Investig Drugs. 2001 Aug;2(8):1120-7. Review. — View Citation

Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. — View Citation

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. — View Citation

Penn DL, Hope DA, Spaulding W, Kucera J. Social anxiety in schizophrenia. Schizophr Res. 1994 Feb;11(3):277-84. — View Citation

Sramek JJ, Zarotsky V, Cutler NR. Generalised anxiety disorder: treatment options. Drugs. 2002;62(11):1635-48. Review. — View Citation

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.

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.

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit
Primary	Sheehan Disability Scale- Change from Baseline to Final Visit
Primary	Lehman Quality of Life Interview- Change from Baseline to Final Visit
Secondary	Instrumental Activities of Daily Living-Change from Baseline to Final Visit
Secondary	Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit.
Secondary	Ultimate game paradigm as a measure of social cohesion- Change from Baseline to Final Visit
Secondary	Arizona sexual dysfunction scale- Change from Baseline to Final Visit
Secondary	COSAPSQ -Change from Baseline to Final Visit
Secondary	HAM-D-Change from Baseline to Final Visit
Secondary	PANSS- Change from Baseline to Final Visit
Secondary	CAGE -Change from Baseline to Final Visit