Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
NCT ID: NCT00177008
Last Updated: 2007-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
18 participants
INTERVENTIONAL
2004-03-31
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Aripiprazole
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
University of Medicine and Dentistry of New Jersey
OTHER
Principal Investigators
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Theodore Petti, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Rutgers, The State University of New Jersey
Robert Stern, MD
Role: STUDY_DIRECTOR
UMDNJ-RWJMS
Locations
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Robert Wood Johnson Medical School - Psychiatry Dept.
Piscataway, New Jersey, United States
Countries
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References
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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.
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.
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.
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.
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.
Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
Bobes J. How is recovery from social anxiety disorder defined? J Clin Psychiatry. 1998;59 Suppl 17:12-9.
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. doi: 10.1176/ajp.139.10.1271.
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. doi: 10.1016/s0014-2999(02)01532-7.
Sramek JJ, Zarotsky V, Cutler NR. Generalised anxiety disorder: treatment options. Drugs. 2002;62(11):1635-48. doi: 10.2165/00003495-200262110-00005.
Leslie RA. Gepirone. Organon. Curr Opin Investig Drugs. 2001 Aug;2(8):1120-7.
Bourin M, Hascoet M. Drug mechanisms in anxiety. Curr Opin Investig Drugs. 2001 Feb;2(2):259-65.
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.
Other Identifiers
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4680
Identifier Type: -
Identifier Source: org_study_id