Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 11:32 AM
Study NCT ID:
NCT01331304
Status:
COMPLETED
Last Update Posted:
2018-04-26
First Post:
2011-04-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness Study for Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008094', 'term': 'Lithium'}, {'id': 'D016651', 'term': 'Lithium Carbonate'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D018020', 'term': 'Lithium Compounds'}, {'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anierenberg@mgh.harvard.edu', 'phone': '617-724-0837', 'title': 'Dr. Andrew Nierenberg', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Six months', 'eventGroups': [{'id': 'EG000', 'title': 'Li + APT', 'description': 'Study participants will take lithium in addition to any other medications recommended by the study physician.\n\nLithium: 600-1200mg per day over 6 months', 'otherNumAtRisk': 240, 'otherNumAffected': 210, 'seriousNumAtRisk': 240, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'QTP + APT', 'description': 'Study participants will take quetiapine in addition to any other medications recommended by the study physician.\n\nQuetiapine: 100-800mg a day over 6 months', 'otherNumAtRisk': 242, 'otherNumAffected': 221, 'seriousNumAtRisk': 242, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Excessive sleepiness/daytime somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 96, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 249, 'numAffected': 186}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 61, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 43, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 58, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 70, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 31, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 55, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 69, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 56, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory/concentration problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness/Lightheaded', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upset stomach/stomach pain/bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Urinary Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stiffness/muscle aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness/muscle fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restless/fidgety (akathisia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infection or other cold-like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle twitching (myoclonus)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Car/Bike Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laparoscopic Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcoholism Treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heroin Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema Outbreak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization reason unknown', 'notes': 'Hospitalization reason unknown; unable to re-contact study participant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken Bones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extreme Sedation Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Spasms Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biliary Cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Study Medication Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoseizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staph Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Adverse reaction to study medication: dizziness, disturbance in gait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Global Impression-Efficacy Index (CGI-EI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Li + APT', 'description': 'Study participants will take lithium in addition to any other medications recommended by the study physician.\n\nLithium: 600-1200mg per day over 6 months'}, {'id': 'OG001', 'title': 'QTP + APT', 'description': 'Study participants will take quetiapine in addition to any other medications recommended by the study physician.\n\nQuetiapine: 100-800mg a day over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.32', 'upperLimit': '1.84'}, {'value': '1.52', 'groupId': 'OG001', 'lowerLimit': '1.26', 'upperLimit': '1.78'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Because this study has co-primary outcomes (CGI-EI and NCAs), the analyses of the treatment effect in the two primary hypotheses each involved a two-tailed alpha-level of 0.025.', 'groupDescription': 'For the first co-primary aim, mixed-effects linear regression analyses compared the two intervention groups on the repeated assessments of the CGI-EI over 6 months.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Average 6 month score minus Average baseline score', 'description': 'The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the most burdensome side effect score (4) and the least therapeutic effect score (1) and a score of +3 is the least burdensome side effect score (1) and the highest therapeutic effect score (4). Higher CGI-EI signifies better outcome (minimal side effects, maximal therapeutic effect). Lower CGI-EI signifies worse outcome (maximal side effects, minimal therapeutic effect).To compute CGI-EI score, we subtract the side effect score from the therapeutic effect score.', 'unitOfMeasure': 'Units on the scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Necessary Clinical Adjustments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Li + APT', 'description': 'Study participants will take lithium in addition to any other medications recommended by the study physician.\n\nLithium: 600-1200mg per day over 6 months'}, {'id': 'OG001', 'title': 'QTP + APT', 'description': 'Study participants will take quetiapine in addition to any other medications recommended by the study physician.\n\nQuetiapine: 100-800mg a day over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '.8', 'spread': '.8', 'groupId': 'OG000'}, {'value': '.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.118', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For the second co-primary, patient monthly rates of NCAs (determined by dividing total number of NCAs during follow-up by the length of follow-up - to account for attrition and resulting differential exposure time) for treatment groups were compared using a Wilcoxon rank-sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Necessary Clinical Adjustment (NCA): The Medication Recommendation Tracking Form was developed and successfully implemented in a previous study to capture recommended medication changes at each study visit 17. Clinicians record dosage changes, missed doses, new medications added or discontinued, and specify the reason for each change. Any change in psychotropic medications, or medications used to treat side effects, is coded along with the reason for the change. NCAs include those changes made for lack of effectiveness or intolerance, but not changes for planned dose titrations.', 'unitOfMeasure': 'Mean NCAs per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risk of Cardiovascular Disease - Framingham Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Li + APT', 'description': 'Study participants will take lithium in addition to any other medications recommended by the study physician.\n\nLithium: 600-900mg per day over 6 months'}, {'id': 'OG001', 'title': 'QTP + APT', 'description': 'Study participants will take quetiapine in addition to any other medications recommended by the study physician.\n\nQuetiapine: 100-800mg a day over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'groupId': 'OG000', 'lowerLimit': '-0.66', 'upperLimit': '0.14'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '-0.21', 'upperLimit': '0.54'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05', 'groupDescription': 'Mixed-effects linear regression analyses compared the two intervention groups on the repeated collection of measures relevant to calculation of the Framingham Risk Score over 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Average baseline score minus Average 6 month score', 'description': 'The Framingham risk score captures the classic risk factors for cardiovascular disease, including age, sex, systolic blood pressure, total and high density lipoprotein cholesterol, diabetes mellitus, and smoking. The Framingham risk score is used as a simple predictive tool to determine 10-year (short term) risk for developing cardiovascular disease (CHD), with higher scores indicating higher risk. Established benchmarks exist for scores from 0 to 25--though it can exceed this value--that are meant to translate to the probability of developing heart disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Li + APT', 'description': 'Study participants will take lithium in addition to any other medications recommended by the study physician.\n\nLithium: 600-900mg per day over 6 months'}, {'id': 'OG001', 'title': 'QTP + APT', 'description': 'Study participants will take quetiapine in addition to any other medications recommended by the study physician.\n\nQuetiapine: 100-800mg a day over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.74', 'groupId': 'OG000', 'lowerLimit': '-4.29', 'upperLimit': '-3.19'}, {'value': '-3.61', 'groupId': 'OG001', 'lowerLimit': '-4.15', 'upperLimit': '-3.07'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05', 'groupDescription': 'Mixed-effects linear regression analyses compared the two intervention groups on the repeated assessment of the LIFE-RIFT over 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Average baseline score minus Average 6-month score', 'description': 'The LIFE-RIFT asses the extent to which psychopathology has impacted current functioning in work, household chores, interpersonal relationships with partner, family, and friends, recreational activities, and life, satisfaction, leisure activities and social relationships. Summary scores can range from 4 to 20, with higher scores indicating greater functional impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Li + APT', 'description': 'Study participants will take lithium in addition to any other medications recommended by the study physician.\n\nLithium: 600-1200mg per day over 6 months'}, {'id': 'FG001', 'title': 'QTP + APT', 'description': 'Study participants will take quetiapine in addition to any other medications recommended by the study physician.\n\nQuetiapine: 100-800mg a day over 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '242'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '182'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '60'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '482', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Li + APT', 'description': 'Study participants will take lithium in addition to any other medications recommended by the study physician.\n\nLithium: 600-1200mg per day over 6 months'}, {'id': 'BG001', 'title': 'QTP + APT', 'description': 'Study participants will take quetiapine in addition to any other medications recommended by the study physician.\n\nQuetiapine: 100-800mg a day over 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '38.9', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '482', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 482}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-29', 'studyFirstSubmitDate': '2011-04-06', 'resultsFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-23', 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression-Efficacy Index (CGI-EI)', 'timeFrame': 'Average 6 month score minus Average baseline score', 'description': 'The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the most burdensome side effect score (4) and the least therapeutic effect score (1) and a score of +3 is the least burdensome side effect score (1) and the highest therapeutic effect score (4). Higher CGI-EI signifies better outcome (minimal side effects, maximal therapeutic effect). Lower CGI-EI signifies worse outcome (maximal side effects, minimal therapeutic effect).To compute CGI-EI score, we subtract the side effect score from the therapeutic effect score.'}, {'measure': 'Necessary Clinical Adjustments', 'timeFrame': '6 Months', 'description': 'Necessary Clinical Adjustment (NCA): The Medication Recommendation Tracking Form was developed and successfully implemented in a previous study to capture recommended medication changes at each study visit 17. Clinicians record dosage changes, missed doses, new medications added or discontinued, and specify the reason for each change. Any change in psychotropic medications, or medications used to treat side effects, is coded along with the reason for the change. NCAs include those changes made for lack of effectiveness or intolerance, but not changes for planned dose titrations.'}], 'secondaryOutcomes': [{'measure': 'Risk of Cardiovascular Disease - Framingham Risk Score', 'timeFrame': 'Average baseline score minus Average 6 month score', 'description': 'The Framingham risk score captures the classic risk factors for cardiovascular disease, including age, sex, systolic blood pressure, total and high density lipoprotein cholesterol, diabetes mellitus, and smoking. The Framingham risk score is used as a simple predictive tool to determine 10-year (short term) risk for developing cardiovascular disease (CHD), with higher scores indicating higher risk. Established benchmarks exist for scores from 0 to 25--though it can exceed this value--that are meant to translate to the probability of developing heart disease.'}, {'measure': 'Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)', 'timeFrame': 'Average baseline score minus Average 6-month score', 'description': 'The LIFE-RIFT asses the extent to which psychopathology has impacted current functioning in work, household chores, interpersonal relationships with partner, family, and friends, recreational activities, and life, satisfaction, leisure activities and social relationships. Summary scores can range from 4 to 20, with higher scores indicating greater functional impairment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bipolar disorder', 'Comparative effectiveness trial', 'Lithium', 'Quetiapine'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '28188565', 'type': 'DERIVED', 'citation': 'Sylvia LG, Montana RE, Deckersbach T, Thase ME, Tohen M, Reilly-Harrington N, McInnis MG, Kocsis JH, Bowden C, Calabrese J, Gao K, Ketter T, Shelton RC, McElroy SL, Friedman ES, Rabideau DJ, Nierenberg AA. Poor quality of life and functioning in bipolar disorder. Int J Bipolar Disord. 2017 Dec;5(1):10. doi: 10.1186/s40345-017-0078-4. Epub 2017 Mar 27.'}, {'pmid': '26845265', 'type': 'DERIVED', 'citation': 'Deckersbach T, Nierenberg AA, McInnis MG, Salcedo S, Bernstein EE, Kemp DE, Shelton RC, McElroy SL, Sylvia LG, Kocsis JH, Bobo WV, Friedman ES, Singh V, Tohen M, Bowden CL, Ketter TA, Calabrese JR, Thase ME, Reilly-Harrington NA, Rabideau DJ, Kinrys G, Kamali M. Baseline disability and poor functioning in bipolar disorder predict worse outcomes: results from the Bipolar CHOICE study. J Clin Psychiatry. 2016 Jan;77(1):100-8. doi: 10.4088/JCP.14m09210.'}, {'pmid': '26845264', 'type': 'DERIVED', 'citation': 'Nierenberg AA, McElroy SL, Friedman ES, Ketter TA, Shelton RC, Deckersbach T, McInnis MG, Bowden CL, Tohen M, Kocsis JH, Calabrese JR, Kinrys G, Bobo WV, Singh V, Kamali M, Kemp D, Brody B, Reilly-Harrington NA, Sylvia LG, Shesler LW, Bernstein EE, Schoenfeld D, Rabideau DJ, Leon AC, Faraone S, Thase ME. Bipolar CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness): a pragmatic 6-month trial of lithium versus quetiapine for bipolar disorder. J Clin Psychiatry. 2016 Jan;77(1):90-9. doi: 10.4088/JCP.14m09349.'}, {'pmid': '25514063', 'type': 'DERIVED', 'citation': 'Bobo WV, Reilly-Harrington NA, Ketter TA, Brody BD, Kinrys G, Kemp DE, Shelton RC, McElroy SL, Sylvia LG, Kocsis JH, McInnis MG, Friedman ES, Singh V, Tohen M, Bowden CL, Deckersbach T, Calabrese JR, Thase ME, Nierenberg AA, Rabideau DJ, Schoenfeld DA, Faraone SV, Kamali M. Complexity of illness and adjunctive benzodiazepine use in outpatients with bipolar I or II disorder: results from the Bipolar CHOICE study. J Clin Psychopharmacol. 2015 Feb;35(1):68-74. doi: 10.1097/JCP.0000000000000257.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of lithium and quetiapine for the treatment of individuals with bipolar disorder.', 'detailedDescription': 'Mood stabilizers, medications that prevent future mood episodes, are the foundation for treatment of bipolar disorder. While all published bipolar disorder treatment guidelines recommend that pharmacotherapy should include mood stabilizers for long-term maintenance treatment, no randomized comparative effectiveness studies have examined the real-world advantages and disadvantages of the newer second generation antipsychotic (SGA) mood stabilizers compared to the classic mood stabilizers, such as lithium (Li). No studies have looked at the effectiveness of SGAs compared to mood stabilizers when used in the context of other medications required to manage bipolar patients, since bipolar disorder patients take a median of 3 medications for optimal outcomes. Quetiapine (QTP) is the most extensively studied, broadly efficacious and the most widely prescribed SGA for bipolar disorder. The classic mood stabilizer Li has the largest evidence base for treating bipolar disorder, but has been largely supplanted by the SGAs.\n\nThus, this study compares symptomatic benefits and adverse effect burden between a QTP foundation with adjunctive personalized treatments (QTP+APT) and a mood stabilizer foundation consisting of Li with APT (Li+APT). APT will include any other medication needed with the following exceptions: the QTP+APT cannot receive Li and the Li+APT group cannot receive an antipsychotic. If, however, participants clinically require a switch to, or the addition of any other SGA or mood stabilizer, then those medications can be added as a rescue strategy that will be carefully recorded. Consistent with an effectiveness trial, participants will be able to continue in the study if they require a rescue treatment. The specific plan is a randomized, open, two arm, comparative effectiveness study of QTP+APT vs. Li+APT treatment for 6 months across 10 sites.\n\nIn summary, this comparative effectiveness study compares fundamentally different acute and continuation treatments for bipolar disorder. The investigators address the key question of whether to use a prototypical mood stabilizing SGA (i.e., QTP) or the classical mood stabilizer Li as the foundational treatment in the context of other necessary adjunctive personalized treatments (APT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meets DSM-IV criteria for BD I or II, which is the primary focus of treatment\n2. Able to give written informed consent\n3. Age \\> to 18 years and \\< 68 years\n4. Women of child bearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence from intercourse; Depo Provera is acceptable if it is started 3 months prior to enrollment), inform their doctor at the earliest possible time of their plans to conceive, and to understand the risks of lithium and other study treatments to the fetus and infant\n5. Currently symptomatic, as defined as a Clinical Global Impression - Bipolar Disorder Overall Severity (CGI-BP-S) score of at least 3 (mild)\n6. If currently taking an SGA, participants would be required to be willing to either discontinue or switch to QTP\n7. Willing to be randomized to either QTP+APT or Li+APT.\n\nExclusion Criteria:\n\n1. Unwilling or unable to comply with study requirements\n2. If maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1\n3. Patients who have had intolerable side effects with QTP or Li\n4. Patients whose clinical status requires inpatient care\n5. Drug/alcohol dependence within the past 30 days\n6. Pregnancy as determined by urine pregnancy test or breastfeeding\n7. History of nonresponse to Li at a serum level of ≥ 1.0 mEq/L ≥ 8 weeks\n8. History of nonresponse to QTP at doses of at least 600 mg ≥ 8 weeks.'}, 'identificationModule': {'nctId': 'NCT01331304', 'briefTitle': 'Comparative Effectiveness Study for Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Comparative Effectiveness of a Second Generation Antipsychotic Mood Stabilizer And a Classic Mood Stabilizer for Bipolar Disorder', 'orgStudyIdInfo': {'id': '2010P001442'}, 'secondaryIdInfos': [{'id': 'R01HS019371-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HS019371-01', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Li + APT', 'description': 'Study participants will take lithium in addition to any other medications recommended by the study physician.', 'interventionNames': ['Drug: Lithium']}, {'type': 'OTHER', 'label': 'QTP + APT', 'description': 'Study participants will take quetiapine in addition to any other medications recommended by the study physician.', 'interventionNames': ['Drug: Quetiapine']}], 'interventions': [{'name': 'Lithium', 'type': 'DRUG', 'otherNames': ['Lithoboid, Eskalith'], 'description': '600-900mg per day over 6 months', 'armGroupLabels': ['Li + APT']}, {'name': 'Quetiapine', 'type': 'DRUG', 'otherNames': ['Seroquel'], 'description': '100-800mg a day over 6 months', 'armGroupLabels': ['QTP + APT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University School of Medicine', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Center of HOPE', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Andrew A Nierenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Bipolar Clinic and Research Program', 'investigatorFullName': 'Andrew A. Nierenberg, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}