Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 3:21 PM
Study NCT ID:
NCT00177008
Status:
COMPLETED
Last Update Posted:
2007-01-29
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2007-01-25', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit'}, {'measure': 'Sheehan Disability Scale- Change from Baseline to Final Visit'}, {'measure': 'Lehman Quality of Life Interview- Change from Baseline to Final Visit'}], 'secondaryOutcomes': [{'measure': 'Instrumental Activities of Daily Living-Change from Baseline to Final Visit'}, {'measure': 'Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit.'}, {'measure': 'Ultimate game paradigm as a measure of social cohesion- Change from Baseline to Final Visit'}, {'measure': 'Arizona sexual dysfunction scale- Change from Baseline to Final Visit'}, {'measure': 'COSAPSQ -Change from Baseline to Final Visit'}, {'measure': 'HAM-D-Change from Baseline to Final Visit'}, {'measure': 'PANSS- Change from Baseline to Final Visit'}, {'measure': 'CAGE -Change from Baseline to Final Visit'}]}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Schizoaffective Disorder', 'Social Anxiety Disorder'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Social Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '8911225', 'type': 'BACKGROUND', '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. doi: 10.1001/archpsyc.1996.01830110060007.'}, {'pmid': '9501887', 'type': 'BACKGROUND', '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. doi: 10.4088/jcp.v59n0204."}, {'pmid': '9565185', 'type': 'BACKGROUND', '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. doi: 10.3109/00048679809062708.'}, {'pmid': '8193064', 'type': 'BACKGROUND', 'citation': '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': '9718633', 'type': 'BACKGROUND', 'citation': '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': '2885745', 'type': 'BACKGROUND', 'citation': 'Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.'}, {'pmid': '9811425', 'type': 'BACKGROUND', 'citation': 'Bobes J. How is recovery from social anxiety disorder defined? J Clin Psychiatry. 1998;59 Suppl 17:12-9.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7124978', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12063084', 'type': 'BACKGROUND', '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. doi: 10.1016/s0014-2999(02)01532-7.'}, {'pmid': '12109925', 'type': 'BACKGROUND', 'citation': 'Sramek JJ, Zarotsky V, Cutler NR. Generalised anxiety disorder: treatment options. Drugs. 2002;62(11):1635-48. doi: 10.2165/00003495-200262110-00005.'}, {'pmid': '11892924', 'type': 'BACKGROUND', 'citation': 'Leslie RA. Gepirone. Organon. Curr Opin Investig Drugs. 2001 Aug;2(8):1120-7.'}, {'pmid': '11816841', 'type': 'BACKGROUND', 'citation': 'Bourin M, Hascoet M. Drug mechanisms in anxiety. Curr Opin Investig Drugs. 2001 Feb;2(2):259-65.'}, {'pmid': '12405524', 'type': 'BACKGROUND', '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. doi: 10.1016/s0887-6185(02)00134-2.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Patients meeting DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder.\n2. 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.\n3. Age 18-65\n4. Gender: males or females\n5. 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)\n6. Good general health\n\nExclusion Criteria:\n\n1. Patient does not meet DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder\n2. 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.\n3. Patients with acute medical conditions are not eligible.\n4. Patients allergic or otherwise intolerant or non-responsive to Aripiprazole\n5. Patient with history of suicidal, homicidal or assaultive plans or attempts in the past 6 months.\n6. Clinically significant EKG or lab abnormalities'}, 'identificationModule': {'nctId': 'NCT00177008', 'briefTitle': 'Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety', 'orgStudyIdInfo': {'id': '4680'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson Medical School - Psychiatry Dept.', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'overallOfficials': [{'name': 'Theodore Petti, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}, {'name': 'Robert Stern, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMDNJ-RWJMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}]}}}