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The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine XR | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine XR | Drug | Oral treatment with 150 up to 300 mg/day once daily in the evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57) | Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113). | Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57). | The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Castiglione | AstraZeneca | Study Director |
| Robert L. Findling | University Hospitals Case Medical CenterCase Western Reserve University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Dothan | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24956042 | Background | Findling RL, Pathak S, Earley WR, Liu S, DelBello MP. Efficacy and safety of extended-release quetiapine fumarate in youth with bipolar depression: an 8 week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2014 Aug;24(6):325-35. doi: 10.1089/cap.2013.0105. Epub 2014 Jun 23. |
| Label | URL |
|---|---|
| CSR-D144AC00001.pdf | View source |
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The study had an up to 35-day enrollment period, 8-week double-blind treatment period with 1 of 2 treatment regimens (quetiapine XR 150 to 300 mg/day or placebo), 1-week safety follow-up period, 2- to 4-week safety follow-up period for patients with BP >95th percentile at completion/discontinuation.
This multicenter study was conducted between 27 January 2009 and 1 November 2010, which included the recall visit. The recall visit occurred from 5 June 2010 till 1 November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine XR | Quetiapine XR 150 to 300mg once a day |
| FG001 | Placebo | Matching placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Oral treatment once daily in the evening |
|
| Days 8 to 57 |
| The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score | The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113). | Days 8 to 57 |
| Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S | The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity. | Change from Baseline to Day 57 |
| CGI-BP-C Score at Final Assessment (Day 57) | The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement. | Change from Baseline to day 57 |
| The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness | The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment. | Day 57 |
| Scottsdale |
| Arizona |
| United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Escondido | California | United States |
| Research Site | Bradenton | Florida | United States |
| Research Site | Gainsville | Florida | United States |
| Research Site | North Miami | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Smyrna | Georgia | United States |
| Research Site | Eagle | Idaho | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | Terre Haute | Indiana | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Clinton Township | Michigan | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | Flowood | Mississippi | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Lincoln | Nebraska | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Mason | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Wharton | Texas | United States |
| Research Site | Virginia Beach | Virginia | United States |
| Research Site | Bothell | Washington | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Bogota D.c | Cundinamarca | Colombia |
| Research Site | Bello | Colombia |
| Research Site | Bogotá | Colombia |
| Research Site | Medellín | Colombia |
| Research Site | Vijaywada | Andh Prad | India |
| Research Site | Ahmedabad | Gujarat | India |
| Research Site | Vadodara | Gujarat | India |
| Research Site | Varanasi | Uttar Prad | India |
| Research Site | León | Mexico |
| Research Site | Monterrey | Mexico |
| Research Site | Belgrade | Serbia |
| Research Site | Novi Sad | Serbia |
| Research Site | Pretoria | Gauteng | South Africa |
| Research Site | Cape Town | W Cape | South Africa |
| Research Site | Taoyuan | Taiwan | Taiwan |
| Research Site | Changhua | Taiwan |
| Research Site | Taipei | Taiwan |
| D144AC00001\_Redacted\_Study\_Protocol | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine XR | Quetiapine XR 150 to 300mg once a day |
| BG001 | Placebo | Matching placebo |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | Safety analysis set | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Safety analysis set | Count of Participants | Participants |
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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 | Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57) | Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57 |
|
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| Secondary | Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57). | The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113). | Posted | Number | participants | Days 8 to 57 |
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| Secondary | The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score | The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113). | Posted | Number | participants | Days 8 to 57 |
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| Secondary | Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S | The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Change from Baseline to Day 57 |
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| ||||||||||||||||||||||||||||||
| Secondary | CGI-BP-C Score at Final Assessment (Day 57) | The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Change from Baseline to day 57 |
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| Secondary | The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness | The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment. | Posted | Number | Proportions | Day 57 |
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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 XR | Quetiapine XR 150 to 300mg once a day | 1 | 68 | 92 | |||
| EG001 | Placebo | Matching placebo | 4 | 66 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Social Stay Hospitalisation | Social circumstances | MedDRA (12.0) | Systematic Assessment |
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| Bipolar Disorder | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Depressive Symptoms | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Nasoparyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Ear Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Upper respiratory Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Irritability | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Thirst | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Increased Appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Orthodontic Appliance Complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrail_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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