Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-30 @ 11:00 PM
Study NCT ID:
NCT00958633
Status:
TERMINATED
Last Update Posted:
2025-05-15
First Post:
2009-08-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D003909', 'term': 'Dexetimide'}, {'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yatham@mail.ubc.ca', 'phone': '604-822-7310', 'title': 'Dr. Lakshmi Yatham', 'organization': 'University Of British Columbia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Recruitment was stopped before the planned sample size was reached owing to the Covid-19 pandemic and expiration of funding.'}}, 'adverseEventsModule': {'timeFrame': '4- 16 weeks on the open-label phase and up to 1 year for each participant in the double-blind phase.', 'description': 'The open-label phase includes adverse events experienced from the 206 participants analyzed in that phase.\n\nThe double-blind phase includes adverse events experienced from the 177 participants analyzed in that phase.', 'eventGroups': [{'id': 'EG000', 'title': '8 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.\n\nEscitalopram 10 - 30 mg or Wellbutrin XL 150 - 450 mg', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 59, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '52 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.\n\nEscitalopram 10 - 30 mg or Wellbutrin XL 150 - 450 mg', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 57, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Open-Label Phase (4-16 Weeks)', 'description': 'Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission.', 'otherNumAtRisk': 206, 'deathsNumAtRisk': 206, 'otherNumAffected': 87, 'seriousNumAtRisk': 206, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain or bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased sex drive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling faint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue or tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased sex drive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor concentration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain ≥7%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization due to discontinuation of treatment, alcohol and drug use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Double-Blind Phase: Number of Participants With an Occurrence of Any Mood Episode (Manic, Hypo-manic, Depressive) During the 52 Week Study Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '8 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.\n\nEscitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg'}, {'id': 'OG001', 'title': '52 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.\n\nEscitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.10', 'estimateComment': 'The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval \\[CI\\], 0.43 to 1.10; P = 0.12 by log-rank test).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 weeks', 'description': 'The primary outcome, assessed in a time-to-event analysis, was any mood episode, defined as any of the following: a Young Mania Rating Scale (YMRS) score of at least 16 (mild mania), a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 (moderate depression), a Clinical Global Impressions Scale, Bipolar Version, Severity (CGI-S-BD) score of at least 4 for mania or depression (moderately ill), hospitalization for mood symptoms, necessity of additional pharmacotherapy for emerging mood symptoms, a MADRS suicide item score of at least 4 (scores range from 0 to 6, with higher scores indicating greater suicide risk), or a suicide attempt or suicide death.\n\nYoung Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes.\n\nClinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '8 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.\n\nEscitalopram 10 - 30 mg Wellbutrin XL 150 - 450 mg'}, {'id': 'OG001', 'title': '52 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.\n\nEscitalopram 10 - 30 mg Wellbutrin XL 150 - 450 mg'}], 'classes': [{'title': 'Manic or hypomanic events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Depressive events', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Mixed episode', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Subsyndromal depressive symptoms', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Subsyndromal manic symptoms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.28', 'ciLowerLimit': '.86', 'ciUpperLimit': '6.08', 'groupDescription': 'Manic or Hypomanic events', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.75', 'groupDescription': 'Depressive Events', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 weeks', 'description': 'Time to a depressive episode, a manic or hypomanic episode, discontinuation from the trial for any clinical reason (e.g., occurrence of a mood event, withdrawal of informed consent, or adverse event), any mood episode or subsyndromal symptoms, time spent in these episodes, and scores on the CGI-BD, YMRS, and MADRS clinical rating scales.\n\nYoung Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes.\n\nClinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the total 178 patients who underwent randomization, 1 had missing data for baseline and post baseline visits and was excluded from the analysis. Thus, the primary analysis included 177 patients, of whom 90 were assigned to the 52-week group and 87 to the 8-week group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '8 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.\n\nEscitalopram 10 - 30 mg daily or Bupropion XL 150 - 450 mg daily\n\n* In patients randomized to the "8-week group", escitalopram/bupropion will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit.'}, {'id': 'FG001', 'title': '52 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.\n\nEscitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg'}, {'id': 'FG002', 'title': 'Open-Label Phase (up to 16 Weeks)', 'description': 'Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.'}], 'periods': [{'title': 'Open-Label (up to 16 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Worsening of symptoms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Non-adherence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}, {'title': 'Double-Blind Phase (up to 52 Weeks)', 'milestones': [{'type': 'STARTED', 'comment': '28 participants entered directly into the double-blind phase and 150 entered from the OL phase. 178 participants were randomized in the double-blind phase of which 1 was excluded due to missing baseline and follow-up data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Excluded due to missing baseline and follow-up data.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '383', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind 8 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.\n\nEscitalopram 10 - 30 mg daily or Bupropion XL 150 - 450 mg daily'}, {'id': 'BG001', 'title': 'Double-blind 52 Week Arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.\n\nEscitalopram 10 - 30 mg daily or Bupropion XL 150 - 450 mg daily'}, {'id': 'BG002', 'title': 'Open-Label Phase (4-16 Weeks)', 'description': 'Patients with BD depression who are receiving treatment with antimanic medication(s) will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Double-blind 8 week and 52 week arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Open-Label 4-16 week arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study.'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Double-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '11.3', 'groupId': 'BG003'}]}]}, {'title': 'Open-Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '40.1', 'spread': '10.9', 'groupId': 'BG002'}, {'value': '40.1', 'spread': '10.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are being reported separately for the Open-label and Double-Blind arms.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Double-blind 8 week arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}, {'title': 'Open-Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are being reported separately for the Open-label and Double-Blind arms.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Double-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Open-Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '176', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are being reported separately for the Open-label and Double-Blind arms.'}, {'title': 'Montgomery Asberg Depression Rating Scale Score', 'classes': [{'title': 'Double-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '2.3', 'groupId': 'BG003'}]}]}, {'title': 'Open-Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '26.6', 'spread': '4.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Montgomery-Asberg Depression Rating Scale (MADRS) is a scale measuring depression severity. The scale ranges from a minimum value of 0 to a maximum value 60. A higher score means a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are being reported separately for the Open-label and Double-Blind arms.'}, {'title': 'Drug Combination - No.', 'classes': [{'title': 'Double-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Bupropion XL plus Mood Stabilizer', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Bupropion XL plus Mood Stabilizer plus SGA', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Bupropion XL plus SGA', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Escitalopram plus Mood Stabilizer', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'Escitalopram plus Mood Stabilizer plus SGA', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Escitalopram plus SGA', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Open-Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Bupropion XL plus Mood Stabilizer', 'measurements': [{'value': '35', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Bupropion XL plus Mood Stabilizer plus SGA', 'measurements': [{'value': '33', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Bupropion XL plus SGA', 'measurements': [{'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Escitalopram plus Mood Stabilizer', 'measurements': [{'value': '53', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Escitalopram plus Mood Stabilizer plus SGA', 'measurements': [{'value': '64', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'Escitalopram plus SGA', 'measurements': [{'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are being reported separately for the Open-label and Double-Blind arms.'}, {'title': 'Region of Enrollment, Customized', 'classes': [{'title': 'Double-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Canada', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'India', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}, {'title': 'South Korea', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Open-Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Canada', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'India', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}, {'title': 'South Korea', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Measure Analysis Population Description: Data are being reported separately for the Open-label and Double-Blind arms.'}], 'populationDescription': 'Some participants who took part in the Open Label Phase were then included in the Double Blind portion of the study therefore certain participants are represented more than once in the Total Arm/Group.\n\nFinal analysis 8 week arm - 87 participants. Excluded one participant due to missing baseline and follow-up data.\n\n52 week arm - 90 participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-28', 'size': 427470, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-26T16:31', 'hasProtocol': True}, {'date': '2021-04-01', 'size': 1208877, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-26T16:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}}, 'statusModule': {'whyStopped': 'Recruitment was stopped before the planned sample size was reached owing to the Covid-19 pandemic and expiration of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2009-08-11', 'resultsFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-14', 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Double-Blind Phase: Number of Participants With an Occurrence of Any Mood Episode (Manic, Hypo-manic, Depressive) During the 52 Week Study Period.', 'timeFrame': '52 weeks', 'description': 'The primary outcome, assessed in a time-to-event analysis, was any mood episode, defined as any of the following: a Young Mania Rating Scale (YMRS) score of at least 16 (mild mania), a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 (moderate depression), a Clinical Global Impressions Scale, Bipolar Version, Severity (CGI-S-BD) score of at least 4 for mania or depression (moderately ill), hospitalization for mood symptoms, necessity of additional pharmacotherapy for emerging mood symptoms, a MADRS suicide item score of at least 4 (scores range from 0 to 6, with higher scores indicating greater suicide risk), or a suicide attempt or suicide death.\n\nYoung Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes.\n\nClinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.'}], 'secondaryOutcomes': [{'measure': 'Double-Blind Phase: Number of Participants Who Had an Episode of Mania/Hypomania, Depression or Mixed During the 52 Week Study Period.', 'timeFrame': '52 weeks', 'description': 'Time to a depressive episode, a manic or hypomanic episode, discontinuation from the trial for any clinical reason (e.g., occurrence of a mood event, withdrawal of informed consent, or adverse event), any mood episode or subsyndromal symptoms, time spent in these episodes, and scores on the CGI-BD, YMRS, and MADRS clinical rating scales.\n\nYoung Mania Rating Scale:Scores range from 0 to 60,lower scores reflect better clinical outcomes. Montgomery-Åsberg Depression Rating Scale: Scores range from 0 to 60, lower scores reflect better clinical outcomes.\n\nClinical Global Impression scale: Scores range from 3 to 42, higher scores reflect worsening status.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bipolar I disorder', 'Depression', 'Antidepressant'], 'conditions': ['Bipolar I Disorder']}, 'referencesModule': {'references': [{'pmid': '37530824', 'type': 'DERIVED', 'citation': 'Yatham LN, Arumugham SS, Kesavan M, Ramachandran K, Murthy NS, Saraf G, Ouyang Y, Bond DJ, Schaffer A, Ravindran A, Ravindran N, Frey BN, Daigneault A, Beaulieu S, Lam RW, Kondapuram N, Reddy MS, Bhandary RP, Ashok MV, Ha K, Ahn YM, Milev R, Wong H, Reddy YCJ; BEAM-BD Trial Group. Duration of Adjunctive Antidepressant Maintenance in Bipolar I Depression. N Engl J Med. 2023 Aug 3;389(5):430-440. doi: 10.1056/NEJMoa2300184.'}]}, 'descriptionModule': {'briefSummary': 'Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients. However, no placebo-controlled trials have assessed the efficacy or safety of modern antidepressants in combination with mood stabilizers in the maintenance treatment of BD. The investigators propose a multicentre, randomized, double-blind clinical trial comparing mood stabilizer plus antidepressant (escitalopram or bupropion XL) to mood stabilizer plus placebo in the maintenance treatment of BD.\n\nThe investigators hypothesize that in clinically representative patients with bipolar disorder, who respond to acute treatment with a newer antidepressant medication in conjunction with a mood stabilizing medication, continuing the antidepressant for 12 months will reduce the risk of relapse into any mood episode, including depression, mania, and hypomania, compared to stopping the antidepressant after 8 weeks.', 'detailedDescription': 'Study Design:\n\nThe investigators propose a multicentre, randomized, double-blind, placebo-controlled trial in patients with BD who are currently experiencing a depressive episode. The trial will consist of two phases: an open-label acute treatment phase, and a double-blind maintenance treatment phase.\n\nOPEN-LABEL ACUTE TREATMENT PHASE\n\nExperimental Design Patients with BD depression who are receiving treatment with antimanic medication(s), defined as: 1) a mood stabilizer (lithium or divalproex ), 2) a second-generation antipsychotic (SGA) (risperidone, olanzapine, quetiapine, aripiprazole, or ziprasidone), or 3) combination anti-manic therapy (two mood stabilizers; or a mood stabilizer plus an SGA (the SGA asenapine will also be permitted if prescribed with a mood stabilizer); or a mood stabilizer or SGA plus lamotrigine), will have open-label escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day added to their medication(s) for up to 16 weeks.Patients who complete at least 4 weeks of treatment and achieve remission from their index depression which is maintained for ≥ 2 weeks will be eligible to enter the double-blind study phase. The duration of treatment in the open-label phase will be 4-16 weeks, depending on the time required to achieve remission.\n\nDOUBLE-BLIND MAINTENANCE TREATMENT PHASE\n\nPatients who are in remission from their index depression for ≥ 2 weeks and ≤ 8 weeks are eligible to take part in the double-blind maintenance phase. There are two routes to enter the double-blind phase:\n\n* following completion of the open-label phase, or\n* following a period of clinical treatment, not exceeding 16 weeks, with the same medications used in the open-label phase. Patients who respond to clinical treatment with carbamazepine plus an antidepressant may also enter the double-blind phase.\n\nExperimental Design\n\nDuring the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:\n\n* Patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines..\n* Patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOPEN-LABEL ACUTE TREATMENT PHASE\n\n1. Diagnosed with BD, current episode depressed, with a MADRS score ≥ 20 at both the screening and baseline assessments\n2. The duration of the current depressive episode is ≥ 2 weeks but ≤ 52 weeks\n3. Taking or initiating treatment with an anti-manic medication at a therapeutic dose. Anti-manic medications and therapeutic doses are: lithium, serum level 0.6-1.4 mEq/L; divalproex, serum level 350-700 mM; risperidone 1-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 300-900 mg/day; aripiprazole 10-30 mg/day; and ziprasidone 80-160 mg/day. Combinations of these medications as outlined above, or the combination of any of them with lamotrigine 100-400 mg daily, or the combination of a mood stabilizer plus asenapine 5-20 mg/day, are also permitted.\n4. If taking any other psychoactive medication (other than lorazepam ≤ 4 mg/day or equivalent), is agreeable to tapering and discontinuing it over a period of ≤ 4 weeks\n5. If female and of childbearing potential, is using an adequate method of contraception.\n6. Aged 18-70 years, inclusive\n7. Fluent in English and capable of providing informed consent\n\nDOUBLE-BLIND MAINTENANCE TREATMENT PHASE\n\n• Patients meeting all of the following criteria will be eligible to be included in the double-blind study phase:\n\n1. Taking escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day, in addition to their anti-manic medication.\n2. Has adequately tolerated the combination of antidepressant plus mood stabilizer, and is currently in remission for ≥ 2 weeks and ≤ 8 weeks\n3. If female and of childbearing potential, is using an adequate method of contraception\n\nExclusion Criteria:\n\nOPEN-LABEL ACUTE TREATMENT PHASE\n\n1. Has a history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months\n2. Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a Young Mania Rating Scale (YMRS) score ≥ 8 at the screening or baseline visits\n3. Has previously been refractory to treatment with both escitalopram and bupropion XL, or has been unable to tolerate both medications due to intolerable side effects or an allergic reaction\n4. Is taking monoamine oxidase inhibitors, such as phenelzine or tranylcypromine\n5. Escitalopram is contraindicated in patients taking pimozide or ziprasidone. Patients on pimozide or ziprasidone can participate in the study and will be prescribed bupropion XL\n6. Bupropion XL is contraindicated in patients taking other preparations containing bupropion, in patients with active eating disorders, including anorexia nervosa and bulimia nervosa; and in patients with seizure disorders. Patients with any of these can still participate in the study and will be prescribed Escitalopram\n7. Has active substance dependence, other than caffeine or nicotine dependence, in the preceding 3 months. Otherwise, patients with comorbid substance abuse or other comorbid psychiatric illnesses will be eligible to participate in the study\n8. Is at high risk for suicide, as defined by a score of ≥ 4 on the suicide item of the MADRS, or in the opinion of the investigator\n9. Has an unstable medical illness, as defined by a change in medication or other treatment in the past 4 weeks, or in the opinion of the investigator\n10. Has significant abnormalities on an electrocardiogram\n11. Is pregnant or lactating\n\nDOUBLE-BLIND MAINTENANCE TREATMENT PHASE\n\n1. Has a history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months\n2. Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a YMRS score ≥ 8 at the screening or baseline visits\n3. Has active substance dependence, other than caffeine or nicotine dependence, in the preceding 3 months. Otherwise, patients with comorbid substance abuse or other comorbid psychiatric illnesses will be eligible to participate in the study\n4. Is at high risk for suicide, as defined by a score of ≥ 4 on the suicide item of the MADRS, or in the opinion of the investigator\n5. Has an unstable medical illness, as defined by a change in medication or other treatment in the past 4 weeks, or in the opinion of the investigator.\n6. Has significant abnormalities on an electrocardiogram\n7. Is pregnant or lactating\n8. Has experienced an episode of mania, hypomania, or a mixed episode during antidepressant treatment of the acute depression, defined as a YMRS score of ≥ 16 at any open-label study visit, or in the opinion of the study psychiatrist'}, 'identificationModule': {'nctId': 'NCT00958633', 'briefTitle': 'Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Mood Stabilizer Plus Antidepressant Versus Mood Stabilizer Plus Placebo in the Maintenance Treatment of Bipolar Disorder', 'orgStudyIdInfo': {'id': 'H09-01017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '8 week arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s)and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 1 patients randomized to the "8 week arm" will discontinue antidepressant treatment after 8 weeks, as recommended in current clinical practice guidelines. The antidepressant will be tapered in a double-blind manner beginning at 6 weeks, and will be substituted with placebo by 8 weeks.\n\nEscitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg', 'interventionNames': ['Drug: Escitalopram', 'Drug: Bupropion XL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '52 week arm', 'description': 'During the double-blind phase, all patients will continue treatment with their anti-manic medication(s) and will be randomized to one of two treatment arms for up to 52 weeks:\n\nGroup 2 patients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.\n\nEscitalopram 10 - 30 mg or Bupropion XL 150 - 450 mg', 'interventionNames': ['Drug: Escitalopram', 'Drug: Bupropion XL']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro/Cipralex'], 'description': 'Escitalopram will be prescribed in the dose range 10-30 mg daily.\n\nIn patients randomized to the "8-week group:\n\n* escitalopram will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit. The dose of escitalopram (or matching placebo) may be decreased in 10 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 10-30 mg daily at all time points.\n\nPatients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.', 'armGroupLabels': ['52 week arm', '8 week arm']}, {'name': 'Bupropion XL', 'type': 'DRUG', 'otherNames': ['Wellbutrin'], 'description': 'Bupropion XL will be prescribed in the dosage range 150-450 mg daily.\n\nIn patients randomized to the "8-week group:\n\n* bupropion XL will be tapered, discontinued, and replaced with placebo over a period of 2 weeks, beginning at the week 6 study visit. The dose of bupropion XL (or matching placebo) may be decreased in 150 mg increments only in the case of intolerable side effects. The dose must remain within the protocol-defined range of 150-450 mg daily at all time points.\n\nPatients randomized to the "52 week arm" will continue treatment with their antidepressant medication for 52 weeks, or until withdrawal from the study.', 'armGroupLabels': ['52 week arm', '8 week arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 2A1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Lakshmi Yatham, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'B. Frey, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': "St. Joseph's Healthcare, Hamilton, Ont."}, {'name': 'S. Beaulieu, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec'}, {'name': 'A. Daigneault, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec'}, {'name': 'A. Ravindran, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre for Addictions and Mental Health, Toronto, Ont.'}, {'name': 'A. Schaffer, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ont.'}, {'name': 'R. Milev, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Queen's University, Kingston, Ontario"}, {'name': 'P. Cervantes, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McGill University Health Centre, Montreal, Que'}, {'name': 'T. H. Ha, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'Y. M. Ahn, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Y. H. Joo, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asan Medical Centre, Korea'}, {'name': 'S. Won, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyungpook National University Hospital, Korea'}, {'name': 'J. Y. Reddy, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Mental Health and Neuro sciences, Bangalore, India'}, {'name': 'P.S. Sharma, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kasturba Medical College Manipal, India'}, {'name': 'M.S. Reddy, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asha Hospital, Hyderabad, India'}, {'name': 'A.V. Mysore, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': "St. John's hospital, Bangalore, India"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Lundbeck Canada Inc.', 'class': 'INDUSTRY'}, {'name': 'Lupin Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lakshmi N Yatham', 'investigatorAffiliation': 'University of British Columbia'}}}}