Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00882518
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2009-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, {'id': 'D002746', 'term': 'Chlorpromazine'}], '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'}, {'id': 'D010640', 'term': 'Phenothiazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.", 'otherNumAtRisk': 196, 'otherNumAffected': 142, 'seriousNumAtRisk': 196, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.", 'otherNumAtRisk': 192, 'otherNumAffected': 166, 'seriousNumAtRisk': 192, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Extrapyramidal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 58}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hepatic Function Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Grand Mal Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-33.4', 'spread': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.45'}, {'value': '-35.9', 'spread': '1.35', 'groupId': 'OG001', 'lowerLimit': '1.35'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population was used as the analysis set for primary outcome, because this is a non-inferior design study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-9.9', 'spread': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.53'}, {'value': '-11.1', 'spread': '0.51', 'groupId': 'OG001', 'lowerLimit': '0.51'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used for secondary outcome'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.50'}, {'value': '-6.7', 'spread': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.48'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used for secondary outcome'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-12.9', 'spread': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.74'}, {'value': '-13.9', 'spread': '0.71', 'groupId': 'OG001', 'lowerLimit': '0.71'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used for secondary outcome'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-4.8', 'spread': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.33'}, {'value': '-5.4', 'spread': '0.32', 'groupId': 'OG001', 'lowerLimit': '0.32'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).\n\n1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used for secondary outcome'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.18'}, {'value': '-1.7', 'spread': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.18'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).\n\n1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used for secondary outcome'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '66.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.\n\n1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used for secondary outcome'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least "minimally improved" at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient\'s change from baseline CGI on a seven-point scale (1="Very much improved", 7="Very much worse".)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used for secondary outcome'}, {'type': 'SECONDARY', 'title': 'Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'OG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.12'}, {'value': '-2.1', 'spread': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.11'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': "6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set was used for secondary outcome'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': "Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion."}, {'id': 'FG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Incorrect enrolment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Central lab closure for National day', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Allocating random number by mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '388 patients from 11 sites were randomised into Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) group or chlorpromazine group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Seroquel_XR', 'description': "Quetiapine fumarate XR was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion. Full analysis set (FAS) population used for baseline characteristics"}, {'id': 'BG001', 'title': 'Chlorpromazine', 'description': "Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion. Full analysis set (FAS) population used for baseline characteristics"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'title': 'age', 'categories': [{'measurements': [{'value': '32.9', 'spread': '10.70', 'groupId': 'BG000'}, {'value': '32.0', 'spread': '10.33', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '10.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2009-04-14', 'resultsFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2009-04-15', 'lastUpdatePostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-16', 'studyFirstPostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.'}, {'measure': 'Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.'}, {'measure': 'Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': 'The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.'}, {'measure': 'Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).\n\n1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme'}, {'measure': 'Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).\n\n1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme'}, {'measure': 'Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.\n\n1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme.'}, {'measure': 'Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': '6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least "minimally improved" at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient\'s change from baseline CGI on a seven-point scale (1="Very much improved", 7="Very much worse".)'}, {'measure': 'Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42', 'timeFrame': 'Baseline and 6 weeks', 'description': "6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'qualified PANSS assessment'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia diagnosis\n* Provision of written informed consent before initiation of any study\n\nExclusion Criteria:\n\n* AIDS and hepatitis B\n* History of seizure disorder\n* Hospitalisation for schizophrenic more than 1 month immediately before enter into study'}, 'identificationModule': {'nctId': 'NCT00882518', 'acronym': 'ESPRIT', 'briefTitle': 'Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients With Acute Episode', 'orgStudyIdInfo': {'id': 'D1444C00008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'description': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day)', 'interventionNames': ['Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2-Chlorpromazine', 'description': 'Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)', 'interventionNames': ['Drug: Chlorpromazine']}], 'interventions': [{'name': 'Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)', 'type': 'DRUG', 'otherNames': ['Seroquel_XR (Quetiapine Fumarate XR)'], 'description': '200 mg or 300 mg, oral, single dose', 'armGroupLabels': ['1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)']}, {'name': 'Chlorpromazine', 'type': 'DRUG', 'description': '50 mg, oral, double dose', 'armGroupLabels': ['2-Chlorpromazine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hunan', 'state': 'Changsha', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.71667, 'lon': 118.83333}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Niufan Gu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Mental Health Center'}, {'name': 'Michael Castiglione', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}