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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine fumarate | Drug | Oral dosing, flexible dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Nature of Adverse Events (AEs) | Number of participants that had AE which occurred from first dose date to last dose date + 30 days. | from open label to week 26+ 30 days |
| Number of Patients Withdrawn Due to AEs. | Number of subjects who withdrew from the study due to AEs. | during 26 weeks of treatment |
| Changes in Laboratory Test Results (Prolactin) | Clinical important shift to high prolactin from open-label (OL) baseline to week 26. High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male. | Duration of study participation |
| Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score | 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). Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score. | OL baseline to week 26 |
| Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score | 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. Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Tanner Stage | Category shift in Tanner stage. Number of subjects who experienced the change is presented. Tanner 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Dothan | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24024534 | Derived | 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. |
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine | Quetiapine 400mg/day to 800mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 26 weeks of treatment |
| Change From Baseline in Weight | Number with 7% or more increase (without adjustment for normal growth) | 26 weeks of treatment |
| Change From Baseline in Supine Pulse | Change from OL baseline to week 26 in supine pulse (bpm) | OL baseline to week 26 |
| Change From OL Baseline in Supine Systolic BP. | Changes from OL baseline to the final visits in Supine systolic BP (mmHg) | OL baseline to Week 26 |
| Change From OL Baseline in Supine Diastolic BP. | Changes from OL baseline to the final visits in Supine diastolic BP (mmHg) | OL baseline to Week 26 |
| Change from OL baseline to week 26 in the Tanner stage |
| Change From Baseline in Children's Global Assessment Scale (CGAS) Score | 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). | OL Baseline to Week 26 |
| Scottsdale |
| Arizona |
| United States |
| Research Site | Cerritos | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Altamonte Springs | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Oak Brook | Illinois | United States |
| Research Site | Newton | Kansas | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Lyndhurst | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Virginia Beach | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Lucknow | India |
| Research Site | Kuala Lumpur | Malaysia |
| Research Site | Petaling Jaya | Malaysia |
| Research Site | Davao City | Philippines |
| Research Site | Mandaluyong | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Poznan | Poland |
| Research Site | Torun | Poland |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Belgrade | Serbia |
| Research Site | Novi Sad | Serbia |
| Research Site | Pretoria | South Africa |
| Research Site | Kharkiv | Ukraine |
| Research Site | Lviv | Ukraine |
| Research Site | Odesa | Ukraine |
| Drug Received |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine | Quetiapine 400mg/day to 800mg/day |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Diagnosis | Number | participant from feeder studies |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence and Nature of Adverse Events (AEs) | Number of participants that had AE which occurred from first dose date to last dose date + 30 days. | Posted | Number | Participants | from open label to week 26+ 30 days |
|
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| |||||||||||||||||||||||||||
| Primary | Number of Patients Withdrawn Due to AEs. | Number of subjects who withdrew from the study due to AEs. | Posted | Number | Participants | during 26 weeks of treatment |
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| Primary | Changes in Laboratory Test Results (Prolactin) | Clinical important shift to high prolactin from open-label (OL) baseline to week 26. High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male. | Posted | Number | Participants | Duration of study participation |
|
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| |||||||||||||||||||||||||||
| Secondary | Changes in Tanner Stage | Category shift in Tanner stage. Number of subjects who experienced the change is presented. Tanner 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. | Number of patients with Tanner stagging data at OL baseline and week 26 (final visit) | Posted | Number | Participants | Change from OL baseline to week 26 in the Tanner stage |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Children's Global Assessment Scale (CGAS) Score | 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). | Number of patients with CGAS score at OL baseline and week 26. | Posted | Mean | Standard Deviation | units on a scale | OL Baseline to Week 26 |
|
| ||||||||||||||||||||||||||
| Primary | Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score | 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). Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score. | Number of patients with SAS score at OL baseline and week 26. | Posted | Number | Participants | OL baseline to week 26 |
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| Primary | Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score | 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. Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score. | Number of patients with BARS score at OL baseline and week 26. | Posted | Number | Participants | 26 weeks of treatment |
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| Primary | Change From Baseline in Weight | Number with 7% or more increase (without adjustment for normal growth) | Number of participants is based on patients with both baseline values and post-baseline values. | Posted | Number | Participants | 26 weeks of treatment |
|
| |||||||||||||||||||||||||||
| Primary | Change From Baseline in Supine Pulse | Change from OL baseline to week 26 in supine pulse (bpm) | Number of participants with OL baseline and post treatment visits | Posted | Mean | Standard Deviation | bpm | OL baseline to week 26 |
|
|
| |||||||||||||||||||||||||
| Primary | Change From OL Baseline in Supine Systolic BP. | Changes from OL baseline to the final visits in Supine systolic BP (mmHg) | Number of participants with OL baseline and post treatment visits | Posted | Mean | Standard Deviation | mmHg | OL baseline to Week 26 |
|
| ||||||||||||||||||||||||||
| Primary | Change From OL Baseline in Supine Diastolic BP. | Changes from OL baseline to the final visits in Supine diastolic BP (mmHg) | Number of participants with OL baseline and post treatment visits | Posted | Mean | Standard Deviation | mmHg | OL baseline to Week 26 |
|
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Other AE module includes adverse events which occurred before first dose date to last dose date + 30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quetiapine | Quetiapine 400mg/day to 800mg/day | 46 | 380 | 340 | 380 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Behaviour | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Amoebiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Bacterial Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Bipola Disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Cellulitis Staphylococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Delusion | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Disinhibition | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Drug Toxicity | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Hallucitnation Auditory | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Hostility | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertensive Crisis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Myocarditis Post Infection | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Perceptual Alteration Paroxysmal | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Physical Assault | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyschotic Disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Schizophrenia, Paraniod Type | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Staphylococcal Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Typhoid Fever | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGITATION | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| FATIGUE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| IRRITABILITY | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| SEDATION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| WEIGHT INCREASED | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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No comparator group, open label treatment, duration only 26 weeks - not long enough to assess full impact on growth and development
AstraZeneca as sponsor will first publish results for the multicenter study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seroquel Medical Science Director, MD | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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