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

NCT00177008 | Completed Phase 4

• 1 other identifier: 4680
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Social Anxiety Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Social Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Interventions

Aripiprazole DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Robert Wood Johnson Medical School - Psychiatry Dept.

Piscataway, New Jersey, 08854, United States

Location

Related Publications (16)

• 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. doi: 10.1001/archpsyc.1996.01830110060007.

  PMID: 8911225 BACKGROUND

• 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. doi: 10.4088/jcp.v59n0204.

  PMID: 9501887 BACKGROUND

• 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. doi: 10.3109/00048679809062708.

  PMID: 9565185 BACKGROUND

• Penn DL, Hope DA, Spaulding W, Kucera J. Social anxiety in schizophrenia. Schizophr Res. 1994 Feb;11(3):277-84. doi: 10.1016/0920-9964(94)90022-1.

  PMID: 8193064 BACKGROUND

• Blanchard JJ, Mueser KT, Bellack AS. Anhedonia, positive and negative affect, and social functioning in schizophrenia. Schizophr Bull. 1998;24(3):413-24. doi: 10.1093/oxfordjournals.schbul.a033336.

  PMID: 9718633 BACKGROUND

• Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.

  PMID: 2885745 BACKGROUND

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

  PMID: 9811425 BACKGROUND

• 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.

  BACKGROUND

• Lehman AF, Ward NC, Linn LS. Chronic mental patients: the quality of life issue. Am J Psychiatry. 1982 Oct;139(10):1271-6. doi: 10.1176/ajp.139.10.1271.

  PMID: 7124978 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1016/s0014-2999(02)01532-7.

  PMID: 12063084 BACKGROUND

• Sramek JJ, Zarotsky V, Cutler NR. Generalised anxiety disorder: treatment options. Drugs. 2002;62(11):1635-48. doi: 10.2165/00003495-200262110-00005.

  PMID: 12109925 BACKGROUND

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

  PMID: 11892924 BACKGROUND

• Bourin M, Hascoet M. Drug mechanisms in anxiety. Curr Opin Investig Drugs. 2001 Feb;2(2):259-65.

  PMID: 11816841 BACKGROUND

• 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. doi: 10.1016/s0887-6185(02)00134-2.

  PMID: 12405524 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Phobia, Social

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Phobic Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Theodore Petti, MD, MPH

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

• Robert Stern, MD

  UMDNJ-RWJMS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2004
• Study Completion: January 1, 2007
• Last Updated: January 29, 2007

Record last verified: 2007-01

Locations

US (1)