Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-22 @ 1:22 AM
Study NCT ID:
NCT00135512
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2005-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of 323U66 SR In Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events (AE) and serious adverse events (SAE) were reported up to Week 52.', 'description': 'All participants who had participated in the study and had received at least 1 dose of the investigational product were included in the safety population and were used for reporting non-SAE and SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 210, 'seriousNumAtRisk': 233, 'deathsNumAffected': 1, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 85}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}], 'seriousEvents': [{'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Intentional misuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.8', 'spread': '8.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 8', 'description': 'The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 8 minus the value at Baseline. Baseline was defined as value at Week 0.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.6', 'spread': '8.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 52 minus the value at Baseline. Baseline was defined as value at Week 0.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '-11.8', 'spread': '6.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-17.3', 'spread': '6.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 8, 52', 'description': 'Each item was rated on either a 3-point scale (0 to 2; 8 questions) or a 5-point scale (0 to 4; 9 questions), with higher scores indicating greater symptom severity. The total score was calculated by summing the individual response scores. Total score ranged from 0 to 52. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. Change from Baseline in the total score was calculated as the score at Week 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '61.0', 'upperLimit': '75.6'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000', 'lowerLimit': '81.6', 'upperLimit': '94.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8, 52', 'description': 'The CGI-I scale was used to rate improvement in the participant\'s condition (benefits) since Baseline using the following 7-point scale: 1: very much improved, 2: much improved, 3: minimally improved, 4: not changed, 5: minimally worse, 6: much worse and 7: very much worse. A responder was defined as "very much improved" or "much improved".', 'unitOfMeasure': 'Percentage of participant', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 8, 52', 'description': 'CGI-SI was assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill and 7, among the most extremely ill. Higher score indicated severely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '-5.0', 'spread': '5.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-9.7', 'spread': '7.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 8, 52', 'description': 'SDISS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant\'s life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. To get a total score, 3 individual scores were added and the total score ranged from "0 = unimpaired" to "30 = highly impaired". Higher scores indicate worsening. The change from Baseline in SDISS total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '15.2', 'spread': '15.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '26.7', 'spread': '20.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 8, 52', 'description': 'The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy and social motivation. Minimal clinically important differences were estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels and items were reverse-scored as necessary such that higher scores represent higher health-related quality of life (HRQoL) total score ranges from 0 to 108 points. Recall period was past week prior to administration. The change from Baseline in MEI-SF total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets twice daily (BID; morning and evening) for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks was administered. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}]}]}], 'recruitmentDetails': 'From 01 December 2004 to 28 May 2007, total of 234 participants with major depressive disorder were randomized at 36 centers in Japan.', 'preAssignmentDetails': 'During the screening (1 week), participants received Dose Level 1; bupropion sustained release (SR) 100 milligrams (mg) placebo tablet once daily in the morning.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupropion SR', 'description': 'During treatment period, participants received Dose Level 2; bupropion SR 100 mg tablets once daily for 1 week in the morning and then the Dose Level 3; bupropion SR 100 mg tablets BID; morning and evening for the next 1 week of the treatment phase. If no problems were observed in tolerability with insufficient efficacy, then Dose Level 4; bupropion SR 150 mg tablets BID for 6 weeks. Dose reduction back to Dose Level 3 was allowed in participants judged by the investigator to have a safety concern after dose increase to Dose Level 4 and dose adjustment between Dose Levels 3 and 4 was to be chosen optionally. If no tolerability issues were observed at Week 8 of treatment phase, the treatment continued up to a maximum of 52 weeks. One tablet was administered per dose during each dose level.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '10.13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '231', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race data for 231 participants is presented and race for 1 participant was unknown.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set was defined as all participants who entered treatment phase, except those who met any of the following criteria: did not satisfy the eligible disease criterion, received no dose of the investigational product and no observation data on post-treatment efficacy.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2007-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2005-08-24', 'resultsFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2005-08-24', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-30', 'studyFirstPostDateStruct': {'date': '2005-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases', 'timeFrame': 'Baseline (Week 0) and Week 8', 'description': 'The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 8 minus the value at Baseline. Baseline was defined as value at Week 0.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 52 minus the value at Baseline. Baseline was defined as value at Week 0.'}, {'measure': 'Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases', 'timeFrame': 'Baseline (Week 0) and Week 8, 52', 'description': 'Each item was rated on either a 3-point scale (0 to 2; 8 questions) or a 5-point scale (0 to 4; 9 questions), with higher scores indicating greater symptom severity. The total score was calculated by summing the individual response scores. Total score ranged from 0 to 52. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. Change from Baseline in the total score was calculated as the score at Week 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.'}, {'measure': 'Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases', 'timeFrame': 'Week 8, 52', 'description': 'The CGI-I scale was used to rate improvement in the participant\'s condition (benefits) since Baseline using the following 7-point scale: 1: very much improved, 2: much improved, 3: minimally improved, 4: not changed, 5: minimally worse, 6: much worse and 7: very much worse. A responder was defined as "very much improved" or "much improved".'}, {'measure': 'Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases', 'timeFrame': 'Baseline (Week 0) and Week 8, 52', 'description': 'CGI-SI was assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill and 7, among the most extremely ill. Higher score indicated severely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.'}, {'measure': 'Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases', 'timeFrame': 'Baseline (Week 0) and Week 8, 52', 'description': 'SDISS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant\'s life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. To get a total score, 3 individual scores were added and the total score ranged from "0 = unimpaired" to "30 = highly impaired". Higher scores indicate worsening. The change from Baseline in SDISS total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.'}, {'measure': 'Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases', 'timeFrame': 'Baseline (Week 0) and Week 8, 52', 'description': 'The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy and social motivation. Minimal clinically important differences were estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels and items were reverse-scored as necessary such that higher scores represent higher health-related quality of life (HRQoL) total score ranges from 0 to 108 points. Recall period was past week prior to administration. The change from Baseline in MEI-SF total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MDD'], 'conditions': ['Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the efficacy and safety in major depressive disorder patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.\n* Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.\n* Must have rating scores as outlined.\n\nExclusion criteria:\n\n* Current or past history of seizure disorder or brain injury.\n* Current or past history of anorexia or bulimia nervosa.\n* History of manic episode.\n* Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.\n* Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.\n* Pregnant, possibly pregnant or lactating.\n* Must not be suicidal.\n* Blood pressure of SBP\\>160mmHg, DBP\\>100mmHg.\n* History or complication of cancer or malignant tumour.'}, 'identificationModule': {'nctId': 'NCT00135512', 'briefTitle': 'Study Of 323U66 SR In Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-Label, Multi-Center, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients With Depression', 'orgStudyIdInfo': {'id': 'AK1102364'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bupropion hydrochloride', 'type': 'DRUG', 'description': 'Study drug'}]}, 'contactsLocationsModule': {'locations': [{'zip': '814-0180', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '651-1145', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '228-0828', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '861-8002', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '332-0012', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}