{"protocolSection":{"identificationModule":{"nctId":"NCT00330616","orgStudyIdInfo":{"id":"AK1102369"},"organization":{"fullName":"GlaxoSmithKline","class":"INDUSTRY"},"briefTitle":"Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan","officialTitle":"Clinical Evaluation of Bupropion SR (323U66)in Patients With Depression - Investigation in Elderly Patients With Depression"},"statusModule":{"statusVerifiedDate":"2009-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-05"},"primaryCompletionDateStruct":{"date":"2007-11","type":"ACTUAL"},"completionDateStruct":{"date":"2007-11","type":"ACTUAL"},"studyFirstSubmitDate":"2006-05-26","studyFirstSubmitQcDate":"2006-05-26","studyFirstPostDateStruct":{"date":"2006-05-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2008-11-26","resultsFirstSubmitQcDate":"2009-03-19","resultsFirstPostDateStruct":{"date":"2009-03-20","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-04-13","lastUpdatePostDateStruct":{"date":"2015-05-04","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Study Director","oldOrganization":"GSK"},"leadSponsor":{"name":"GlaxoSmithKline","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"This is a study to obtain clinical experience of 323U66 SR for elderly patients with depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory investigation on safety, efficacy and pharmacokinetics profile in elderly patients with depression."},"conditionsModule":{"conditions":["Major Depressive Disorder (MDD)"],"keywords":["WELLBUTRIN","elderly","depression","Pharmacokinetics"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":35,"type":"ACTUAL"}},"armsInterventionsModule":{"interventions":[{"type":"DRUG","name":"323U66 SR"}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","timeFrame":"Baseline and Week 8"}],"secondaryOutcomes":[{"measure":"Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","timeFrame":"Baseline and Week 4"},{"measure":"Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","timeFrame":"Baseline and Week 8"},{"measure":"Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of \\>/= 50% total score on the HAM D.","timeFrame":"Week 4"},{"measure":"Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of \\>/= 50% total score on the HAM D.","timeFrame":"Week 8"},{"measure":"Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of \\</= 7.","timeFrame":"Week 4"},{"measure":"Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of \\</= 7.","timeFrame":"Week 8"},{"measure":"Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","timeFrame":"Baseline and Week 4"},{"measure":"Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","timeFrame":"Baseline and Week 8"},{"measure":"Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4","description":"The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).","timeFrame":"Baseline and Week 4"},{"measure":"Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8","description":"The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","timeFrame":"Baseline and Week 8"},{"measure":"Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8","description":"The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","timeFrame":"Week 4 and Week 8"},{"measure":"Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8","description":"The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.","timeFrame":"Week 4 and Week 8"},{"measure":"Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8","description":"The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).","timeFrame":"Baseline, Weeks 1, 2, 3, 4, 8"},{"measure":"Adverse Events (>=5% Incidence)","timeFrame":"Baseline through Week 8"},{"measure":"Serious Adverse Events","timeFrame":"Baseline through Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n* Target disease: Patients diagnosed as having the following primary disease and current major depressive episode for at least 8 weeks on the basis of DSM-IV-TR criteria.\n\n  * Major Depressive Disorder, Single Episode (296.2x) (excluding those with psychotic features)\n  * Major Depressive Disorder, Recurrent (296.3x). (excluding those with psychotic features)\n* HAM-D (17 items) total score \\>/=18.\n* Age: \\>/=65 years old (at the time of informed consent)\n* Gender: Male or female.\n* Inpatient or outpatient status: Either\n* Informed consent: The subject himself/herself must give written informed consent.\n\nExclusion criteria:\n\n* Patients with predisposition to seizure (who currently have or have a past history of seizure, febrile convulsive seizure in infancy, cerebral tumour, cerebrovascular disorder or head injury, who have a family history of idiopathic seizure, patients with diabetes who have been treated with oral hypoglycaemics or insulin, or who use drugs lowering the threshold of seizure)\n* Patients who currently have or have a past history of the following disorders:\n\n  * Anorexia nervosa (DSM-IV-TR 307.1)\n  * Bulimia nervosa (DSM-IV-TR 307.51)\n* Patients with a history of manic episode\n* Patients with a past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder\n* Patients with a current DSM-IV-TR Axis II diagnosis (e.g., antisocial or borderline personality disorder)\n* Patients starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) and standardized cognitive behaviour therapy within 12 weeks prior to the start of the treatment phase\n* Patients with a diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria or with a diagnosis of substance dependence within 1 year prior to the start of the treatment phase\n* Patients who have received electroconvulsive therapy within 24 weeks prior to the start of the treatment phase\n* Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the treatment phase\n* Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase\n* Patients who have attempted suicide within 24 weeks prior to the start of the treatment phase, or patients for whom the score of the suicide-related item of HAM-D is \\>/=3, or patients in whom the risk of suicide is judged to be high by the investigator (sub-investigator).\n* Patients in whom the risk of homicide is judged to be high by the investigator (sub-investigator).\n* Patients with a history of hypersensitivity to 323U66\n* Patients with serious cerebral disease\n* Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) assesses the subject is predisposed to ischemia or arrhythmia\n* Patients with serious physical symptoms (i.e. cardiac/hepatic/renal disorder, hematopoietic disorder).\n\nThe index of seriousness is Grade 3 of \"Criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc.\" (PAB/PSD No.80 in 1992).\n\n* Patients who have a history or complicated carcinoma or malignant tumour.\n* Patients whose major depressive disorder is due to direct physiological effects of a general medical condition (for example, hypothyroidism, Parkinson's disease, chronic pain)\n* Patients with systolic blood pressure of \\>/=160 mmHg or diastolic blood pressure of \\>/=100 mmHg at the start of the Treatment Period\n* Patients diagnosed with dementia\n* Patients who are inappropriate for participating in the study in the judgement of the investigator (sub-investigator).","healthyVolunteers":false,"sex":"ALL","minimumAge":"65 Years","stdAges":["OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"GSK Clinical Trials, MD","affiliation":"GlaxoSmithKline","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"GSK Investigational Site","city":"Fukuoka","zip":"815-0041","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"GSK Investigational Site","city":"Fukushima","zip":"961-0021","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"facility":"GSK Investigational Site","city":"Kumamoto","zip":"861-8002","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"GSK Investigational Site","city":"Nagano","zip":"395-0056","country":"Japan","geoPoint":{"lat":36.65,"lon":138.18333}},{"facility":"GSK Investigational Site","city":"Nagano","zip":"399-8695","country":"Japan","geoPoint":{"lat":36.65,"lon":138.18333}},{"facility":"GSK Investigational Site","city":"Saitama","zip":"332-0012","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"GSK Investigational Site","city":"Tokyo","zip":"164-0012","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"GSK Investigational Site","city":"Tokyo","zip":"170-0002","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"GSK Investigational Site","city":"Tokyo","zip":"189-0012","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Bupropion SR","description":"Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"35"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"13"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"35"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"73.5","spread":"5.08"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"26"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"9"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Asian - Japanese Heritage","categories":[{"measurements":[{"groupId":"BG000","value":"35"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.4","spread":"10.34"}]}]}]},{"type":"SECONDARY","title":"Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of Change","timeFrame":"Baseline and Week 4","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-41.7","spread":"25.40"}]}]}]},{"type":"SECONDARY","title":"Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of Change","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-60.7","spread":"30.54"}]}]}]},{"type":"SECONDARY","title":"Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of \\>/= 50% total score on the HAM D.","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Responders","timeFrame":"Week 4","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29.4","spread":"25.40"}]}]}]},{"type":"SECONDARY","title":"Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of \\>/= 50% total score on the HAM D.","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Responders","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"64.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of \\</= 7.","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Remitters","timeFrame":"Week 4","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17.6","spread":"30.54"}]}]}]},{"type":"SECONDARY","title":"Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of \\</= 7.","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Remitters","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline and Week 4","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"}]}],"classes":[{"title":"Depressed Mood","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"1.23"}]}]},{"title":"Feelings of Guilt","categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"0.99"}]}]},{"title":"Suicide","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.03"}]}]},{"title":"Insomnia Early","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.87"}]}]},{"title":"Insomnia Middle","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.72"}]}]},{"title":"Insomnia Late","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.94"}]}]},{"title":"Work/Activities","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.17"}]}]},{"title":"Retardation","categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"0.53"}]}]},{"title":"Anxiety Psychic","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.14"}]}]},{"title":"Anxiety Somatic","categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"0.81"}]}]},{"title":"Somatic Symptoms GI","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"0.77"}]}]},{"title":"Somatic Symptoms General","categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"0.90"}]}]},{"title":"Genital Symptoms","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.80"}]}]},{"title":"Hypochondriasis","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.94"}]}]},{"title":"Lose Weight History","categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"0.88"}]}]},{"title":"Insight","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.62"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8","description":"The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"classes":[{"title":"Depressed Mood","categories":[{"measurements":[{"groupId":"OG000","value":"-1.9","spread":"1.46"}]}]},{"title":"Feelings of Guilt","categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"1.11"}]}]},{"title":"Suicide","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"0.92"}]}]},{"title":"Insomnia Early","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"0.86"}]}]},{"title":"Insomnia Middle","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.74"}]}]},{"title":"Insomnia Late","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"0.86"}]}]},{"title":"Work/Activities","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"1.50"}]}]},{"title":"Retardation","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"0.63"}]}]},{"title":"Agitation","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.94"}]}]},{"title":"Anxiety Psychic","categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"1.34"}]}]},{"title":"Anxiety Somatic","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"0.86"}]}]},{"title":"Somatic Symptoms GI","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.84"}]}]},{"title":"Somatic Symptoms General","categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"0.89"}]}]},{"title":"Genital Symptoms","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.93"}]}]},{"title":"Hypochondriasis","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.07"}]}]},{"title":"Lose Weight History","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"1.21"}]}]},{"title":"Insight","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.63"}]}]}]},{"type":"SECONDARY","title":"Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4","description":"The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of Change","timeFrame":"Baseline and Week 4","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"}]}],"classes":[{"title":"Depressed Mood","categories":[{"measurements":[{"groupId":"OG000","value":"-47.1","spread":"39.74"}]}]},{"title":"Feelings of Guilt","categories":[{"measurements":[{"groupId":"OG000","value":"-76.7","spread":"34.43"}]}]},{"title":"Suicide","categories":[{"measurements":[{"groupId":"OG000","value":"-80.0","spread":"36.84"}]}]},{"title":"Insomnia Early","categories":[{"measurements":[{"groupId":"OG000","value":"-41.7","spread":"59.67"}]}]},{"title":"Insomnia Middle","categories":[{"measurements":[{"groupId":"OG000","value":"-40.6","spread":"58.36"}]}]},{"title":"Insomnia Late","categories":[{"measurements":[{"groupId":"OG000","value":"-42.9","spread":"47.46"}]}]},{"title":"Work/Activities","categories":[{"measurements":[{"groupId":"OG000","value":"-27.9","spread":"31.86"}]}]},{"title":"Retardation","categories":[{"measurements":[{"groupId":"OG000","value":"-73.5","spread":"31.21"}]}]},{"title":"Agitation","categories":[{"measurements":[{"groupId":"OG000","value":"-45.8","spread":"68.28"}]}]},{"title":"Anxiety Psychic","categories":[{"measurements":[{"groupId":"OG000","value":"-34.8","spread":"43.72"}]}]},{"title":"Anxiety Somatic","categories":[{"measurements":[{"groupId":"OG000","value":"-54.2","spread":"39.67"}]}]},{"title":"Somatic Symptoms GI","categories":[{"measurements":[{"groupId":"OG000","value":"-21.4","spread":"57.89"}]}]},{"title":"Somatic Symptoms General","categories":[{"measurements":[{"groupId":"OG000","value":"-17.9","spread":"50.41"}]}]},{"title":"Genital Symptoms","categories":[{"measurements":[{"groupId":"OG000","value":"-40.9","spread":"62.52"}]}]},{"title":"Hypochondriasis","categories":[{"measurements":[{"groupId":"OG000","value":"-38.1","spread":"44.54"}]}]},{"title":"Lose Weight History","categories":[{"measurements":[{"groupId":"OG000","value":"-57.7","spread":"44.94"}]}]},{"title":"Insight","categories":[{"measurements":[{"groupId":"OG000","value":"-60.0","spread":"51.64"}]}]}]},{"type":"SECONDARY","title":"Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8","description":"The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of Change","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"classes":[{"title":"Depressed Mood","categories":[{"measurements":[{"groupId":"OG000","value":"-60.7","spread":"40.62"}]}]},{"title":"Feelings of Guilt","categories":[{"measurements":[{"groupId":"OG000","value":"-100.0","spread":"0"}]}]},{"title":"Suicide","categories":[{"measurements":[{"groupId":"OG000","value":"-83.3","spread":"32.57"}]}]},{"title":"Insomnia Early","categories":[{"measurements":[{"groupId":"OG000","value":"-70.0","spread":"42.16"}]}]},{"title":"Insomnia Middle","categories":[{"measurements":[{"groupId":"OG000","value":"-50.0","spread":"61.24"}]}]},{"title":"Insomnia Late","categories":[{"measurements":[{"groupId":"OG000","value":"-68.2","spread":"46.22"}]}]},{"title":"Work/Activities","categories":[{"measurements":[{"groupId":"OG000","value":"-42.3","spread":"46.74"}]}]},{"title":"Retardation","categories":[{"measurements":[{"groupId":"OG000","value":"-78.6","spread":"32.31"}]}]},{"title":"Agitation","categories":[{"measurements":[{"groupId":"OG000","value":"-52.8","spread":"77.76"}]}]},{"title":"Anxiety Psychic","categories":[{"measurements":[{"groupId":"OG000","value":"-55.4","spread":"48.88"}]}]},{"title":"Anxiety Somatic","categories":[{"measurements":[{"groupId":"OG000","value":"-60.7","spread":"55.32"}]}]},{"title":"Somatic Symptoms GI","categories":[{"measurements":[{"groupId":"OG000","value":"-45.8","spread":"62.01"}]}]},{"title":"Somatic Symptoms General","categories":[{"measurements":[{"groupId":"OG000","value":"-50.0","spread":"60.30"}]}]},{"title":"Genital Symptoms","categories":[{"measurements":[{"groupId":"OG000","value":"-45.5","spread":"65.02"}]}]},{"title":"Hypochondriasis","categories":[{"measurements":[{"groupId":"OG000","value":"-50.0","spread":"43.23"}]}]},{"title":"Lose Weight History","categories":[{"measurements":[{"groupId":"OG000","value":"-81.8","spread":"33.71"}]}]},{"title":"Insight","categories":[{"measurements":[{"groupId":"OG000","value":"-50.0","spread":"70.71"}]}]}]},{"type":"SECONDARY","title":"Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8","description":"The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Week 4 and Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"17.3","spread":"6.94"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"15.7","spread":"8.41"}]}]}]},{"type":"SECONDARY","title":"Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8","description":"The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Responders","timeFrame":"Week 4 and Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"33"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"24.2"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"42.4"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8","description":"The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).","populationDescription":"Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline, Weeks 1, 2, 3, 4, 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"}]}],"classes":[{"title":"Week 1","categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"0.63"}]}]},{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.73"}]}]},{"title":"Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.86"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.99"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.22"}]}]}]},{"type":"SECONDARY","title":"Adverse Events (>=5% Incidence)","populationDescription":"Safety population - all subjects who took at least one dose of study medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline through Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"}]}],"classes":[{"title":"Nausea","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"Constipation","categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]},{"title":"Dizziness","categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]},{"title":"Nasopharyngitis","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"Pyrexia","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Thirst","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Weight Decreased","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Glossitis","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Paraesthesia Oral","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Vomiting","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Irritability","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Oedema Peripheral","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Somnolence","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Blood Pressure Increased","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Pruritus","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Depression","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Excoriation","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Back Pain","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}]},{"type":"SECONDARY","title":"Serious Adverse Events","populationDescription":"Safety population - all subjects who took at least one dose of study medication.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline through Week 8","groups":[{"id":"OG000","title":"Bupropion SR"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Bupropion SR","description":"Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.","seriousNumAffected":1,"otherNumAffected":31}],"seriousEvents":[{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":35}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":35}]},{"term":"Nasopharyngitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}]},{"term":"Thirst","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}]},{"term":"Weight decrease","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":35}]},{"term":"Glossitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Paraesthesia oral","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Irritability","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Edema Peripheral","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Somnolence","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Blood Pressure increased","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Pruritus","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Excoriation","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]},{"term":"Back Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":35}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial."},"pointOfContact":{"title":"GSK Response Center","organization":"GlaxoSmithKline","phone":"866-435-7343"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]}},"hasResults":true}