Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00064467
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2003-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lethargic Depression Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D053608', 'term': 'Stupor'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2003-07-08', 'studyFirstSubmitQcDate': '2003-07-09', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.'}], 'secondaryOutcomes': [{'measure': 'Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.'}]}, 'conditionsModule': {'keywords': ['lethargic', 'decreased interest', 'decreased motivation', 'depression'], 'conditions': ['Epilepsy', 'Major Depressive Disorder (MDD)']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Rush J, VanMeter SA, Wightman D, Hampton KD, Krishen A, Modell JG. Wellbutrin XL for the treatment of adults with major depressive disorder. American Psychiatric Association 158th Annual Meeting, Atlanta, GA, 21-26 May, 2005, Abstract No. 787.'}, {'pmid': '16848645', 'type': 'RESULT', 'citation': 'Jefferson JW, Rush AJ, Nelson JC, VanMeter SA, Krishen A, Hampton KD, Wightman DS, Modell JG. Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2006 Jun;67(6):865-73. doi: 10.4088/jcp.v67n0602.'}, {'type': 'RESULT', 'citation': 'Rush J, VanMeter SA, Wightman DS, Hampton KD, Krishen A, Modell JG. Bupropion XL for the treatment of adults with major depressive disorder. 45th Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting, Boca Raton, FL, 6-9June, 2005.'}]}, 'descriptionModule': {'briefSummary': 'This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.', 'detailedDescription': 'A Multicenter, Double-Blind, Placebo-controlled comparison of the efficacy and safety of flexible dose extended-release bupropion (HCl) 300-450 mg/day and placebo administered for eight weeks for the treatment of adult outpatients with major depressive disorder including symptoms of decreased energy, pleasure, and interest'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years.\n* Generally in good health.\n* Subject must read and write at a level sufficient to provide written informed consent.\n\nExclusion criteria:\n\n* Current or past history of seizure disorder.\n* Subject has a primary diagnosis or received treatment for panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), acute stress disorder, Bipolar I or II disorder, schizophrenia, or other psychotic disorder.\n* Currently using illicit drugs or other psychotropic drugs.\n* Patient poses a current suicidal risk or has attempted suicide in the past 6 months.'}, 'identificationModule': {'nctId': 'NCT00064467', 'briefTitle': 'Lethargic Depression Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An 8 Week, Multicenter, Randomized, Double-blind, Placebo Controlled Comparison of the Efficacy of Extended Release Bupropion Hydrochloride and Placebo in the Treatment of Adult Outpatients With Major Depressive Disorder With Lethargic Symptoms', 'orgStudyIdInfo': {'id': 'AK130931'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Extended-release bupropion (HCl)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '80212', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06416', 'city': 'Cromwell', 'state': 'Connecticut', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'zip': '06518', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '06457', 'city': 'Middletown', 'state': 'Connecticut', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.56232, 'lon': -72.65065}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '52401', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48336', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '39157', 'city': 'Ridgeland', 'state': 'Mississippi', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.42848, 'lon': -90.13231}}, {'zip': '08057', 'city': 'Moorestown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.96706, 'lon': -74.94267}}, {'zip': '87108', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '02865-4208', 'city': 'Lincoln', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.92111, 'lon': -71.435}}, {'zip': '78746', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77566', 'city': 'Lake Jackson', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.03386, 'lon': -95.43439}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}