Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-01 @ 10:22 PM
Study NCT ID:
NCT00926393
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
2009-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
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': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'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': 'AZTrial_Results_Posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The PI agrees to collaborate in good faith with AstraZeneca with regards to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release', 'otherNumAtRisk': 69, 'otherNumAffected': 33, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release', 'otherNumAtRisk': 70, 'otherNumAffected': 29, 'seriousNumAtRisk': 70, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '45.022', 'groupId': 'OG000', 'lowerLimit': '38.287', 'upperLimit': '51.758'}, {'value': '32.472', 'groupId': 'OG001', 'lowerLimit': '25.935', 'upperLimit': '39.009'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour post-dose, Day 2 (50 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.', 'unitOfMeasure': 'units on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.'}, {'type': 'SECONDARY', 'title': 'Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '51.521', 'spread': '3.341', 'groupId': 'OG000', 'lowerLimit': '3.341'}, {'value': '29.146', 'spread': '3.239', 'groupId': 'OG001', 'lowerLimit': '3.239'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour post-dose, Day 3 (100 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.'}, {'type': 'SECONDARY', 'title': 'Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '48.336', 'spread': '3.703', 'groupId': 'OG000', 'lowerLimit': '3.703'}, {'value': '30.130', 'spread': '3.609', 'groupId': 'OG001', 'lowerLimit': '3.609'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour post-dose, Day 4 (200 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.'}, {'type': 'SECONDARY', 'title': 'Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '49.414', 'spread': '4.347', 'groupId': 'OG000', 'lowerLimit': '4.347'}, {'value': '32.626', 'spread': '4.258', 'groupId': 'OG001', 'lowerLimit': '4.258'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour post-dose, Day 5 (300 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.'}, {'type': 'SECONDARY', 'title': 'Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '48.959', 'spread': '4.015', 'groupId': 'OG000', 'lowerLimit': '4.015'}, {'value': '30.144', 'spread': '3.910', 'groupId': 'OG001', 'lowerLimit': '3.910'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour post-dose, Day 6 (300 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.'}, {'type': 'SECONDARY', 'title': 'Maximum Intensity Modified Bond-Lader Visual Analog Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '99.929', 'spread': '1.353', 'groupId': 'OG000', 'lowerLimit': '1.353'}, {'value': '96.937', 'spread': '1.313', 'groupId': 'OG001', 'lowerLimit': '1.313'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'During Day 2 (50 mg)', 'description': 'The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '3.685', 'spread': '0.246', 'groupId': 'OG000', 'lowerLimit': '0.246'}, {'value': '4.254', 'spread': '0.239', 'groupId': 'OG001', 'lowerLimit': '0.239'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'During Day 2 (50 mg)', 'description': 'Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.'}, {'type': 'SECONDARY', 'title': 'Area Under the Modified Bond-Lader Visual Analog Scale-time Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '1061.12', 'spread': '31.559', 'groupId': 'OG000', 'lowerLimit': '31.559'}, {'value': '988.842', 'spread': '30.612', 'groupId': 'OG001', 'lowerLimit': '30.612'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'During Day 2 (50 mg)', 'description': 'Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose', 'unitOfMeasure': 'mm * hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.'}, {'type': 'SECONDARY', 'title': 'Change in Simpson-Angus Scale (SAS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to Day 7', 'description': 'SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.'}, {'type': 'SECONDARY', 'title': 'Change in Barnes Akathisia Rating Scale (BARS) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to Day 7', 'description': 'BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.'}, {'type': 'SECONDARY', 'title': 'Change in Abnormal Involuntary Movement Scale (AIMS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to Day 7', 'description': 'AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Potential Extrapyramidal Symptoms (EPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of the study treatment to last dose plus 30 days', 'description': 'Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Potential Somnolence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'OG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of the study treatment to last dose plus 30 days', 'description': 'Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'FG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A 7-day, inpatient, multicenter, double-blind, double-dummy, randomized, parallel group, Phase IV study was done to compare the tolerability of quetiapine IR with quetiapine XR during initial dose escalation in patients with bipolar depression. In total 139 patients were randomized in 15 centers in the USA between June and August 2009.', 'preAssignmentDetails': 'Patients must have DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed, and outpatient status at enrollment . Patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Quetiapine IR', 'description': 'Quetiapine fumarate Immediate Release'}, {'id': 'BG001', 'title': 'Quetiapine XR', 'description': 'Quetiapine fumarate Extended Release'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-39', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': '40-50', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-10', 'studyFirstSubmitDate': '2009-06-19', 'resultsFirstSubmitDate': '2010-05-04', 'studyFirstSubmitQcDate': '2009-06-22', 'lastUpdatePostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-06', 'studyFirstPostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)', 'timeFrame': 'At 1 hour post-dose, Day 2 (50 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.'}], 'secondaryOutcomes': [{'measure': 'Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)', 'timeFrame': 'At 1 hour post-dose, Day 3 (100 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.'}, {'measure': 'Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)', 'timeFrame': 'At 1 hour post-dose, Day 4 (200 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.'}, {'measure': 'Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)', 'timeFrame': 'At 1 hour post-dose, Day 5 (300 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.'}, {'measure': 'Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)', 'timeFrame': 'At 1 hour post-dose, Day 6 (300 mg)', 'description': 'The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.'}, {'measure': 'Maximum Intensity Modified Bond-Lader Visual Analog Scale Score', 'timeFrame': 'During Day 2 (50 mg)', 'description': 'The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments'}, {'measure': 'Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score', 'timeFrame': 'During Day 2 (50 mg)', 'description': 'Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas'}, {'measure': 'Area Under the Modified Bond-Lader Visual Analog Scale-time Curve', 'timeFrame': 'During Day 2 (50 mg)', 'description': 'Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose'}, {'measure': 'Change in Simpson-Angus Scale (SAS) Total Score', 'timeFrame': 'Randomization to Day 7', 'description': 'SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.'}, {'measure': 'Change in Barnes Akathisia Rating Scale (BARS) Global Score', 'timeFrame': 'Randomization to Day 7', 'description': 'BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.'}, {'measure': 'Change in Abnormal Involuntary Movement Scale (AIMS) Total Score', 'timeFrame': 'Randomization to Day 7', 'description': 'AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements.'}, {'measure': 'Number of Patients With Potential Extrapyramidal Symptoms (EPS)', 'timeFrame': 'From start of the study treatment to last dose plus 30 days', 'description': 'Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness'}, {'measure': 'Number of Patients With Potential Somnolence', 'timeFrame': 'From start of the study treatment to last dose plus 30 days', 'description': 'Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inpatient', 'bipolar depression', 'quetiapine', 'Seroquel IR', 'Seroquel XR', 'safety', 'tolerability'], 'conditions': ['Bipolar Depression']}, 'referencesModule': {'references': [{'pmid': '23059166', 'type': 'DERIVED', 'citation': 'Riesenberg RA, Baldytcheva I, Datto C. Self-reported sedation profile of quetiapine extended-release and quetiapine immediate-release during 6-day initial dose escalation in bipolar depression: a multicenter, randomized, double-blind, phase IV study. Clin Ther. 2012 Nov;34(11):2202-11. doi: 10.1016/j.clinthera.2012.09.002. Epub 2012 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed\n* Outpatient status as enrollment\n\nExclusion Criteria:\n\n* Other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.'}, 'identificationModule': {'nctId': 'NCT00926393', 'briefTitle': 'Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) With Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalation in Patients With Bipolar Depression', 'orgStudyIdInfo': {'id': 'D1443C00040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quetiapine Immediate Release (IR)', 'description': 'Quetiapine 25, 100, 200 and 300 mg', 'interventionNames': ['Drug: Quetiapine Immediate Release']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quetiapine Extended Release (XR)', 'description': 'Quetiapine 50, 200, 300', 'interventionNames': ['Drug: Quetiapine Extended Release']}], 'interventions': [{'name': 'Quetiapine Immediate Release', 'type': 'DRUG', 'otherNames': ['Seroquel IR'], 'description': 'Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day', 'armGroupLabels': ['Quetiapine Immediate Release (IR)']}, {'name': 'Quetiapine Extended Release', 'type': 'DRUG', 'otherNames': ['Seroquel XR'], 'description': 'Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day', 'armGroupLabels': ['Quetiapine Extended Release (XR)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catherine Datto, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hans Eriksson, MD, Medical Science Sr Director', 'oldOrganization': 'AstraZeneca'}}}}