Viewing Study NCT00048360


Ignite Creation Date: 2025-12-25 @ 2:06 AM
Ignite Modification Date: 2025-12-26 @ 3:07 AM
Study NCT ID: NCT00048360
Status: COMPLETED
Last Update Posted: 2013-02-12
First Post: 2002-10-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D013035', 'term': 'Spasm'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-11', 'studyFirstSubmitDate': '2002-10-30', 'studyFirstSubmitQcDate': '2002-10-30', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADHD Rating Scale'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impressions -Severity and Improvement.'}, {'measure': 'Quality of Life Enjoyment and Satisfaction Questionnaire.'}]}, 'conditionsModule': {'keywords': ['ADD', 'ADHD', 'attention deficit', 'hyperactivity'], 'conditions': ['Attention Deficit Disorder']}, 'descriptionModule': {'briefSummary': 'This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient must be diagnosed with ADHD.\n\nExclusion Criteria:\n\n* Patient has a current or past history of seizure disorder, brain injury, anorexia nervosa or bulimia.\n* Patient has a current diagnosis of Major Depressive Disorder (MDD).\n* Patient has a current primary diagnosis of, or received treatment for, Panic Disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD) or Acute Stress Disorder within the previous 12 months.\n* Patient has a lifetime diagnosis of bipolar disorder, schizophrenia or other psychotic disorders.\n* Patient has a positive urine test at screening for presence of illicit drugs or alcohol abuse during the past 12 months.'}, 'identificationModule': {'nctId': 'NCT00048360', 'briefTitle': 'Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An 8-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Comparison of Extended-Release Bupropion Hydrochloride 300-450 mg/Day to Assess the Efficacy, Safety, and Effects on Health Outcomes in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'AK130934'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Extended-release bupropion hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '94549', 'city': 'Lafayette', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 37.88576, 'lon': -122.11802}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 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40.76078, 'lon': -111.89105}}, {'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '05091', 'city': 'Woodstock', 'state': 'Vermont', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 43.62424, 'lon': -72.51843}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'GSK Clinical Trial, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}}}}