Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT00236067
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078308', 'term': 'Tiagabine'}], 'ancestors': [{'id': 'D009557', 'term': 'Nipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2005-10-07', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale.'}], 'secondaryOutcomes': [{'measure': 'Assessment of proportion of responders and patients in remission according to HAM-A scores and CGI ratings by visit, assessment of the safety and tolerability in patients with GAD'}]}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).\n\nExclusion Criteria:\n\n* Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD\n* Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months\n* Have been diagnosed with any eating disorder within the past six months\n* Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder\n* Have any history of alcohol or substance abuse within 3 months of screening\n* Have any history of seizures, including febrile seizures\n* Have any history of head trauma associated with loss of consciousness within the past 15 years'}, 'identificationModule': {'nctId': 'NCT00236067', 'briefTitle': 'A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Gabitril(up to 16 mg/Day) in the Treatment of Adults With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'C6671/3031/AX/US'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gabitril', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Research Group', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Southwestern Research Institute', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinical Research', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '30080', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', 'facility': 'Carman Research', 'geoPoint': {'lat': 33.88399, 'lon': -84.51438}}, {'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Clinical Research Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '41042', 'city': 'Florence', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Hartford Research Group', 'geoPoint': {'lat': 38.99895, 'lon': -84.62661}}, {'zip': '48864', 'city': 'Okemos', 'state': 'Michigan', 'country': 'United States', 'facility': 'Summit Research Network', 'geoPoint': {'lat': 42.72226, 'lon': -84.42747}}, {'zip': '08021', 'city': 'Clementon', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CNS Research Institute', 'geoPoint': {'lat': 39.8115, 'lon': -74.98294}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Social Psychiatry Research Inst.', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11559', 'city': 'Lawrence', 'state': 'New York', 'country': 'United States', 'facility': 'Neurobehavioral Research, Inc.', 'geoPoint': {'lat': 40.61566, 'lon': -73.72958}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Social Psychiatry Research Inst.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10024', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Medical Research Network', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Northcoast Clinical Trials', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97209', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Summit Research Network', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Clinical Research Services', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '84107-7591', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Radiant Research, Salt Lake City', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22201', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Comprehensive Neuroscience of Northern Virginia', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Summit Research Network', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cephalon', 'class': 'INDUSTRY'}}}}