Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-02 @ 12:34 PM
Study NCT ID:
NCT00613067
Status:
COMPLETED
Last Update Posted:
2010-06-30
First Post:
2008-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-07-21', 'releaseDate': '2011-06-24'}], 'estimatedResultsFirstSubmitDate': '2011-06-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-29', 'studyFirstSubmitDate': '2008-01-29', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event related potential (ERP) N100', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': '- HAMA - HAMD - CGI - Beck Anxiety Inventory(self rating)', 'timeFrame': 'baseline, 2, 4, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Generalized anxiety disorder', 'N100', 'Central serotonergic activity'], 'conditions': ['Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '15902586', 'type': 'RESULT', 'citation': 'Linka T, Muller BW, Bender S, Sartory G, Gastpar M. The intensity dependence of auditory evoked ERP components predicts responsiveness to reboxetine treatment in major depression. Pharmacopsychiatry. 2005 May;38(3):139-43. doi: 10.1055/s-2005-864126.'}, {'pmid': '17316822', 'type': 'RESULT', 'citation': 'Linka T, Sartory G, Bender S, Gastpar M, Muller BW. The intensity dependence of auditory ERP components in unmedicated patients with major depression and healthy controls. An analysis of group differences. J Affect Disord. 2007 Nov;103(1-3):139-45. doi: 10.1016/j.jad.2007.01.018. Epub 2007 Feb 20.'}, {'pmid': '15337269', 'type': 'RESULT', 'citation': 'Linka T, Muller BW, Bender S, Sartory G. The intensity dependence of the auditory evoked N1 component as a predictor of response to Citalopram treatment in patients with major depression. Neurosci Lett. 2004 Sep 9;367(3):375-8. doi: 10.1016/j.neulet.2004.06.038.'}]}, 'descriptionModule': {'briefSummary': 'Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone intensities have been suggested as a correlative of central serotonergic activity. A strong loudness dependence amplitude increase (strong intensity dependence) reflects low serotonergic neurotransmission and vice versa. Many researchers assumed that the brain serotonergic activity could influence treatment response of highly selective serotonin reuptake inhibitors in depression and anxiety disorders. There are a couple of studies reporting associations of N1 amplitude intensity dependence with response to Citalopram (positive correlation) and Reboxetine (negative correlation) treatment in major depressive disorder patients. But so far there have been no reports about associations between ERP N1 and antidepressant response in GAD patients.\n\nSo, it would be very interesting to explore the correlations between ERP N1 amplitude change and the Escitalopram treatment responsiveness in GAD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV TR for GAD\n* Hamilton Rating Scale for Anxiety (HAMA) \\>18\n* 18 to 75 years old\n\nExclusion Criteria:\n\n* Severe medical illness\n* Other psychiatric illness\n* HAMD \\> 18\n* High suicidal risk\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00613067', 'acronym': 'N1', 'briefTitle': 'ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'IB-0709-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GAD', 'description': '35 patients with Generalized Anxiety disorder', 'interventionNames': ['Drug: escitalopram']}], 'interventions': [{'name': 'escitalopram', 'type': 'DRUG', 'otherNames': ['lexapro'], 'description': "* Start with escitalopram 10mg\n* According to patient's symptoms, stay on 10mg or increase up to 20mg\n* Concomitant therapy : up to Xanax 0.5mg, or Ativan 1mg, not allowed above these dosages\n* Length of washout period will be at least 2 weeks for any psychotropic drugs", 'armGroupLabels': ['GAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '414-410', 'city': 'Goyang', 'state': 'Kyunggi', 'country': 'South Korea', 'facility': 'Psychiatry department, Inje Univ. Ilsanpaik Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}], 'overallOfficials': [{'name': 'Seung-Hwan Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatry department, Inje Univ. Ilsanpaik Hospital'}, {'name': 'Young-Min Park, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Psychiatry department, Inje Univ. Ilsanpaik Hospital'}, {'name': 'Sung-Man Bae, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Psychiatry department, Inje Univ. Ilsanpaik Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Seung-Hwan Lee', 'oldOrganization': 'Department of Psychiatry, Inje Univ. Ilsanpaik Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-06-24', 'type': 'RELEASE'}, {'date': '2011-07-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Department of Psychiatry, Inje Univ. Ilsanpaik Hospital (Seung-Hwan Lee)'}}}}