{"protocolSection":{"identificationModule":{"nctId":"NCT00186446","orgStudyIdInfo":{"id":"GSK 103341"},"organization":{"fullName":"Stanford University","class":"OTHER"},"briefTitle":"Treatment of Nicotine Dependence and Acute Depression","officialTitle":"Treatment of Nicotine Dependence and Acute Depression"},"statusModule":{"statusVerifiedDate":"2017-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-06"},"primaryCompletionDateStruct":{"date":"2007-09","type":"ACTUAL"},"completionDateStruct":{"date":"2007-09","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-13","studyFirstSubmitQcDate":"2005-09-13","studyFirstPostDateStruct":{"date":"2005-09-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-10-18","resultsFirstSubmitQcDate":"2017-02-15","resultsFirstPostDateStruct":{"date":"2017-04-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-02-15","lastUpdatePostDateStruct":{"date":"2017-04-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Alan Schatzberg","investigatorTitle":"Professor","investigatorAffiliation":"Stanford University"},"leadSponsor":{"name":"Stanford University","class":"OTHER"},"collaborators":[{"name":"GlaxoSmithKline","class":"INDUSTRY"}]},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.","detailedDescription":"The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation."},"conditionsModule":{"conditions":["Major Depressive Disorder","Nicotine Dependence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":20,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion","type":"EXPERIMENTAL","interventionNames":["Drug: bupropion and smoking cessation behavioral intervention"]}],"interventions":[{"type":"DRUG","name":"bupropion and smoking cessation behavioral intervention","armGroupLabels":["Bupropion"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton Depression Scale Score","description":"Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.","timeFrame":"baseline to week 10"},{"measure":"Cessation of Smoking","description":"Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.","timeFrame":"Week 10"},{"measure":"Can Depression and Smoking Cessation be Treated Simultaneously","description":"This was measured by the drop out rate during the study.","timeFrame":"Dropouts over course of study"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age at least 18 at the beginning of the study\n* Smoking at least 10 cigarettes a day (1/2 pack)\n* Meets DSM-IV criteria for major depressive episode\n\nExclusion Criteria:\n\n* Currently pregnant\n* Currently breastfeeding\n* Currently diagnosed with a seizure disorder, liver disease, kidney disease, congestive heart failure or diabetes mellitis\n* History of a seizure, seizure disorder, significant head trauma or central nervous system tumor\n* Family history of seizures\n* Currently using intravenous drugs\n* Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis\n* Currently using any over-the-counter stimulants and anorectics (diet pills)\n* Currently on fluoxetine (Prozac), bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL) or any other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa\n* Currently on NRT or bupropion (Zyban)\n* Current or past diagnosis of anorexia nervosa\n* Previous allergic response to fluoxetine, bupropion, or NRT\n* Previous failed quit attempt using NRT and bupropion in combination\n* Current suicidal ideation\n* Current or past psychosis, mania/hypomania, or any other Axis I or Axis II psychiatric diagnosis other than major depression and nicotine dependence","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Anna Lembke, MD","affiliation":"Stanford University","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Stanford University School of Medicine","city":"Stanford","state":"California","zip":"94305","country":"United States","geoPoint":{"lat":37.42411,"lon":-122.16608}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Bupropion and Smoking Cessation Behavioral Intervention","description":"Medication for depression and behavioral intervention for smoking cessation"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion and Smoking Cessation Behavioral Intervention"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"20"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.35","spread":"10.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"17"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"20"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton Depression Scale Score","description":"Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.","populationDescription":"9 patients did not complete the study and we used last observation carried forward","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of change in depression","timeFrame":"baseline to week 10","groups":[{"id":"OG000","title":"Bupropion and Smoking Cessation Behavioral Intervention"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-.5322","spread":".27"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.001","statisticalMethod":"t-test, 2 sided","statisticalComment":"t(19)= -8.93"}]},{"type":"PRIMARY","title":"Cessation of Smoking","description":"Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.","populationDescription":"Carbon monoxide levels available on 8 subjects at week 10.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 10","groups":[{"id":"OG000","title":"Bupropion and Smoking Cessation Behavioral Intervention","description":"Medication for depression and behavioral intervention for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]}]},{"type":"PRIMARY","title":"Can Depression and Smoking Cessation be Treated Simultaneously","description":"This was measured by the drop out rate during the study.","populationDescription":"Number dropped out of the study","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Dropouts over course of study","groups":[{"id":"OG000","title":"Bupropion and Smoking Cessation Behavioral Intervention","description":"bupropion and behavioral intervention"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Bupropion and Smoking Cessation Behavioral Intervention","seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":0,"otherNumAtRisk":20}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"aimee-noelle swanson","organization":"Stanford University","email":"aimnoe@stanford.edu","phone":"650-736-4559"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D014029","term":"Tobacco Use Disorder"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}