Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-13 @ 2:43 PM
Study NCT ID:
NCT00566150
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2007-11-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Levetiracetam in the Management of Bipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zubin.bhagwagar@yale.edu', 'phone': '203-974-7560', 'title': 'Dr. Zubin Bhagwagar', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during course of the study and for two weeks after last study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Levetiracetam', 'description': 'Subjects on active study medication.', 'otherNumAtRisk': 19, 'otherNumAffected': 17, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects assigned to placebo control group.', 'otherNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coordination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shakiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomanic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of depressive symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Slurred speech', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sunstance Abuse Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in suicidality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cognitive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drooling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unusual dreams/nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nosebleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Subjects on active study medication.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to placebo control group.'}], 'classes': [{'title': 'Week 1 (n=17, n=15)', 'categories': [{'measurements': [{'value': '-2.7647', 'spread': '1.4138', 'groupId': 'OG000'}, {'value': '-4', 'spread': '1.5051', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=15, n=14)', 'categories': [{'measurements': [{'value': '-3.4259', 'spread': '1.4618', 'groupId': 'OG000'}, {'value': '-6.5875', 'spread': '1.5327', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=13, n=14)', 'categories': [{'measurements': [{'value': '-2.1243', 'spread': '1.5441', 'groupId': 'OG000'}, {'value': '-6.3625', 'spread': '1.5458', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=11, n=13)', 'categories': [{'measurements': [{'value': '-4.3534', 'spread': '1.6582', 'groupId': 'OG000'}, {'value': '-6.3851', 'spread': '1.583', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=11, n=13)', 'categories': [{'measurements': [{'value': '-6.952', 'spread': '1.7105', 'groupId': 'OG000'}, {'value': '-6.4368', 'spread': '1.6006', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=10, n=11)', 'categories': [{'measurements': [{'value': '-4.8136', 'spread': '1.7806', 'groupId': 'OG000'}, {'value': '-7.0712', 'spread': '1.6838', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Unadjusted. Statistical significance was p\\<0.05.', 'groupDescription': 'Comparison of changes in outcome between treatment groups at week 6.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 6', 'description': 'Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Subjects on active study medication.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to placebo control group.'}], 'classes': [{'title': 'Week 1 (n=17, n=15)', 'categories': [{'measurements': [{'value': '-3.2941', 'spread': '2.0145', 'groupId': 'OG000'}, {'value': '-2.7333', 'spread': '2.1446', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=15, n=14)', 'categories': [{'measurements': [{'value': '-5.2319', 'spread': '2.1105', 'groupId': 'OG000'}, {'value': '-7.256', 'spread': '2.1999', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=13, n=14)', 'categories': [{'measurements': [{'value': '-3.384', 'spread': '2.2162', 'groupId': 'OG000'}, {'value': '-9.0417', 'spread': '2.1999', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=11, n=13)', 'categories': [{'measurements': [{'value': '-5.5505', 'spread': '2.3441', 'groupId': 'OG000'}, {'value': '-8.7608', 'spread': '2.2514', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=11, n=12)', 'categories': [{'measurements': [{'value': '-9.9142', 'spread': '2.3441', 'groupId': 'OG000'}, {'value': '-6.6591', 'spread': '2.3061', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=10, n=11)', 'categories': [{'measurements': [{'value': '-6.5208', 'spread': '2.4183', 'groupId': 'OG000'}, {'value': '-4.5153', 'spread': '2.3691', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Unadjusted. Statistical significance was p\\<0.05.', 'groupDescription': 'Comparison of changes in outcome between treatment groups at week 6.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 6', 'description': 'Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Achieve Remission.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Subjects on active study medication.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to placebo control group.'}], 'classes': [{'title': 'Remitted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Not remitted', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.038', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was p\\<0.05', 'groupDescription': 'Week 6', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': "Fisher's exact test was used to test for significance between groups."}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'Remission response is measured as an HDRS-21 total score is less than or equal to 7.\n\nHDRS-21 measures range of depressive symptoms. Endpoint is LOCF.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Subjects on active study medication.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects assigned to placebo control group.'}], 'classes': [{'title': 'Week 1 (n=17, n=15)', 'categories': [{'measurements': [{'value': '-0.2941', 'spread': '0.1982', 'groupId': 'OG000'}, {'value': '-0.4667', 'spread': '0.211', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=14, n=14)', 'categories': [{'measurements': [{'value': '-0.3186', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '-0.6956', 'spread': '0.2161', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=13, n=14)', 'categories': [{'measurements': [{'value': '-0.1984', 'spread': '0.2207', 'groupId': 'OG000'}, {'value': '-0.7753', 'spread': '0.2177', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=11, n=13)', 'categories': [{'measurements': [{'value': '-0.3729', 'spread': '0.2386', 'groupId': 'OG000'}, {'value': '-0.8403', 'spread': '0.2238', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=11, n=12)', 'categories': [{'measurements': [{'value': '-0.7325', 'spread': '0.244', 'groupId': 'OG000'}, {'value': '-0.8739', 'spread': '0.2322', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=10, n=10)', 'categories': [{'measurements': [{'value': '-0.5742', 'spread': '0.2539', 'groupId': 'OG000'}, {'value': '-0.9294', 'spread': '0.2505', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Unadjusted. Statistical significance was p\\<0.05.', 'groupDescription': 'Comparison of changes in outcome between treatment groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 6', 'description': 'Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levetiracetam', 'description': 'Subjects on active study medication.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects assigned to placebo control group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 2005-2008 from New Haven, CT and surrounding areas.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Levetiracetam', 'description': 'Subjects on active study medication.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects assigned to placebo control group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2007-11-29', 'resultsFirstSubmitDate': '2009-10-02', 'studyFirstSubmitQcDate': '2007-11-30', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-29', 'studyFirstPostDateStruct': {'date': '2007-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.', 'timeFrame': 'Baseline to week 6', 'description': 'Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.'}], 'secondaryOutcomes': [{'measure': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.', 'timeFrame': 'Baseline to week 6', 'description': 'Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.'}, {'measure': 'Number of Subjects Who Achieve Remission.', 'timeFrame': 'Week 6', 'description': 'Remission response is measured as an HDRS-21 total score is less than or equal to 7.\n\nHDRS-21 measures range of depressive symptoms. Endpoint is LOCF.'}, {'measure': 'Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.', 'timeFrame': 'Baseline to week 6', 'description': 'Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Keppra', 'Levetiracetam', 'Anticonvulsant', 'Depression', 'Bipolar Disorder', 'Affective Disorders', 'Mood Disorders', 'Double Blind', 'Acute Antidepressant Effects'], 'conditions': ['Bipolar Depression']}, 'referencesModule': {'references': [{'pmid': '17140277', 'type': 'BACKGROUND', 'citation': 'Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. doi: 10.2165/00023210-200620120-00002.'}, {'pmid': '21034692', 'type': 'DERIVED', 'citation': 'Saricicek A, Maloney K, Muralidharan A, Ruf B, Blumberg HP, Sanacora G, Lorberg B, Pittman B, Bhagwagar Z. Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of bipolar disorder\n* Presence of a current major depressive episode on the SCID\n* Score of 17 or great on the HDRS\n* Capable of giving voluntary written consent\n\nExclusion Criteria:\n\n* Significant current substance dependence/abuse within 3 months preceding the trial\n* Active suicidal ideation\n* Pregnant/lactating mothers\n* Significant medical history'}, 'identificationModule': {'nctId': 'NCT00566150', 'briefTitle': 'Levetiracetam in the Management of Bipolar Depression', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Levetiracetam in the Management of Bipolar Depression', 'orgStudyIdInfo': {'id': '0508000506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levetiracetam', 'interventionNames': ['Drug: Levetiracetam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'Flexible dose up to 2500mg per day, for 6 weeks.', 'armGroupLabels': ['Levetiracetam']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Flexible dose up to 2500mg per day, for 6 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Zubin Bhagwagar, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanley Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}