Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00227305
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2005-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic 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': 'Seroquel Medical Science Director, MD', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'AstraZeneca as sponsor will first publish results for the multicenter study', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No comparator group, open label treatment, duration only 26 weeks - not long enough to assess full impact on growth and development'}}, 'adverseEventsModule': {'timeFrame': 'Other AE module includes adverse events which occurred before first dose date to last dose date + 30 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day', 'otherNumAtRisk': 380, 'otherNumAffected': 340, 'seriousNumAtRisk': 380, 'seriousNumAffected': 46}], 'otherEvents': [{'term': 'AGITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INCREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 76}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 43}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SEDATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 72}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 115}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Abnormal Behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bacterial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bipola Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cellulitis Staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Disinhibition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Drug Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hallucitnation Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hostility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocarditis Post Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Perceptual Alteration Paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Physical Assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyschotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Schizophrenia, Paraniod Type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Typhoid Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence and Nature of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '321', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from open label to week 26+ 30 days', 'description': 'Number of participants that had AE which occurred from first dose date to last dose date + 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients Withdrawn Due to AEs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during 26 weeks of treatment', 'description': 'Number of subjects who withdrew from the study due to AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Laboratory Test Results (Prolactin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of study participation', 'description': 'Clinical important shift to high prolactin from open-label (OL) baseline to week 26.\n\nHigh Prolactin is defined as value \\>26 ug/L for female and value \\>20 ug/L for male.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Tanner Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Change from OL baseline to week 26 in the Tanner stage', 'description': 'Category shift in Tanner stage. Number of subjects who experienced the change is presented.\n\nTanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients with Tanner stagging data at OL baseline and week 26 (final visit)'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Global Assessment Scale (CGAS) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '13.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL Baseline to Week 26', 'description': "Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients with CGAS score at OL baseline and week 26.'}, {'type': 'PRIMARY', 'title': 'Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'OL baseline to week 26', 'description': 'Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).\n\nImproved define as those with a \\<= -1 change in SAS total score. Worsened defined as those with a \\>=1 change in SAS total score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients with SAS score at OL baseline and week 26.'}, {'type': 'PRIMARY', 'title': 'Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks of treatment', 'description': 'Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.\n\nImproved defined as those with a \\<= -1 change in BARS global score. Worsened defined as those with a \\>= 1 change in BARS global score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients with BARS score at OL baseline and week 26.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks of treatment', 'description': 'Number with 7% or more increase (without adjustment for normal growth)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants is based on patients with both baseline values and post-baseline values.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Supine Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '14.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL baseline to week 26', 'description': 'Change from OL baseline to week 26 in supine pulse (bpm)', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with OL baseline and post treatment visits'}, {'type': 'PRIMARY', 'title': 'Change From OL Baseline in Supine Systolic BP.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '11.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL baseline to Week 26', 'description': 'Changes from OL baseline to the final visits in Supine systolic BP (mmHg)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with OL baseline and post treatment visits'}, {'type': 'PRIMARY', 'title': 'Change From OL Baseline in Supine Diastolic BP.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '9.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'OL baseline to Week 26', 'description': 'Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with OL baseline and post treatment visits'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'enrolled', 'groupId': 'FG000', 'numSubjects': '381'}]}, {'type': 'Drug Received', 'achievements': [{'comment': 'safety population', 'groupId': 'FG000', 'numSubjects': '380'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 26 weeks', 'groupId': 'FG000', 'numSubjects': '237'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Study specific discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'MOVED OUT OF AREA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'PERIOD SHORTENED FROM 6 wks to 4 wks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'LEAVING TOWN FOR 6 WEEKS', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NECESSITY OF USING ANTI DEPRESSANT', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment was contingent on completing one of 2 short term efficacy studies, recruitment period August 2004 through July 2007 at 59 international clinical research sites', 'preAssignmentDetails': 'Required to have completed one feeder study, either bipolar mania study D1441C00149 or schizophrenia study D1441C00112 and be willing to participate in a 26 week open label study and be between the ages of 10 and 18 years at the time of consent for this study, initial titration to maintain blind in feeder study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Quetiapine', 'description': 'Quetiapine 400mg/day to 800mg/day'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '10 - 12 years', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}, {'title': '13 - 18 years', 'categories': [{'measurements': [{'value': '293', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '154', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '226', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Bipolar', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}]}]}, {'title': 'Schizophrenia', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participant from feeder studies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2005-09-27', 'resultsFirstSubmitDate': '2008-12-22', 'studyFirstSubmitQcDate': '2005-09-27', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-05', 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and Nature of Adverse Events (AEs)', 'timeFrame': 'from open label to week 26+ 30 days', 'description': 'Number of participants that had AE which occurred from first dose date to last dose date + 30 days.'}, {'measure': 'Number of Patients Withdrawn Due to AEs.', 'timeFrame': 'during 26 weeks of treatment', 'description': 'Number of subjects who withdrew from the study due to AEs.'}, {'measure': 'Changes in Laboratory Test Results (Prolactin)', 'timeFrame': 'Duration of study participation', 'description': 'Clinical important shift to high prolactin from open-label (OL) baseline to week 26.\n\nHigh Prolactin is defined as value \\>26 ug/L for female and value \\>20 ug/L for male.'}, {'measure': 'Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score', 'timeFrame': 'OL baseline to week 26', 'description': 'Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).\n\nImproved define as those with a \\<= -1 change in SAS total score. Worsened defined as those with a \\>=1 change in SAS total score.'}, {'measure': 'Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score', 'timeFrame': '26 weeks of treatment', 'description': 'Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.\n\nImproved defined as those with a \\<= -1 change in BARS global score. Worsened defined as those with a \\>= 1 change in BARS global score.'}, {'measure': 'Change From Baseline in Weight', 'timeFrame': '26 weeks of treatment', 'description': 'Number with 7% or more increase (without adjustment for normal growth)'}, {'measure': 'Change From Baseline in Supine Pulse', 'timeFrame': 'OL baseline to week 26', 'description': 'Change from OL baseline to week 26 in supine pulse (bpm)'}, {'measure': 'Change From OL Baseline in Supine Systolic BP.', 'timeFrame': 'OL baseline to Week 26', 'description': 'Changes from OL baseline to the final visits in Supine systolic BP (mmHg)'}, {'measure': 'Change From OL Baseline in Supine Diastolic BP.', 'timeFrame': 'OL baseline to Week 26', 'description': 'Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)'}], 'secondaryOutcomes': [{'measure': 'Changes in Tanner Stage', 'timeFrame': 'Change from OL baseline to week 26 in the Tanner stage', 'description': 'Category shift in Tanner stage. Number of subjects who experienced the change is presented.\n\nTanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.'}, {'measure': "Change From Baseline in Children's Global Assessment Scale (CGAS) Score", 'timeFrame': 'OL Baseline to Week 26', 'description': "Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal)."}]}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Bipolar I Disorder'], 'conditions': ['Schizophrenia', 'Bipolar I Disorder']}, 'referencesModule': {'references': [{'pmid': '24024534', 'type': 'DERIVED', 'citation': 'Findling RL, Pathak S, Earley WR, Liu S, DelBello M. Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):490-501. doi: 10.1089/cap.2012.0092. Epub 2013 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is able to provide written assent and the parents or legal guardian of the patient are/is able to provide written informed consent before beginning any study related procedures\n* Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112\n* Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder\n* Patient's parent or legal guardian will be able to accompany the patient to each scheduled study visit\n\nExclusion Criteria:\n\n* Patients (female) must not be pregnant or lactating\n* Patients with a known intolerance or lack of response to previous treatment with quetiapine\n* Patients who have previously participated in this study"}, 'identificationModule': {'nctId': 'NCT00227305', 'acronym': 'ANCHOR 150', 'briefTitle': 'Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 26-week, Multicenter, Open-label Phase 3b Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents With Bipolar I Disorder and Adolescents With Schizophrenia (Abbreviated)', 'orgStudyIdInfo': {'id': 'D1441C00150'}}, 'armsInterventionsModule': {'interventions': [{'name': 'quetiapine fumarate', 'type': 'DRUG', 'otherNames': ['Seroquel'], 'description': 'Oral dosing, flexible dosing'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dothan', 'state': 'Alabama', 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