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The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine Immediate Release (IR) | Active Comparator | Quetiapine 25, 100, 200 and 300 mg |
|
| Quetiapine Extended Release (XR) | Active Comparator | Quetiapine 50, 200, 300 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine Immediate Release | Drug | Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | At 1 hour post-dose, Day 2 (50 mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | At 1 hour post-dose, Day 3 (100 mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Datto, MD | AstraZeneca | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23059166 | Derived | Riesenberg RA, Baldytcheva I, Datto C. Self-reported sedation profile of quetiapine extended-release and quetiapine immediate-release during 6-day initial dose escalation in bipolar depression: a multicenter, randomized, double-blind, phase IV study. Clin Ther. 2012 Nov;34(11):2202-11. doi: 10.1016/j.clinthera.2012.09.002. Epub 2012 Oct 8. |
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Patients must have DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed, and outpatient status at enrollment . Patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.
A 7-day, inpatient, multicenter, double-blind, double-dummy, randomized, parallel group, Phase IV study was done to compare the tolerability of quetiapine IR with quetiapine XR during initial dose escalation in patients with bipolar depression. In total 139 patients were randomized in 15 centers in the USA between June and August 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine IR | Quetiapine fumarate Immediate Release |
| FG001 | Quetiapine XR | Quetiapine fumarate Extended Release |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine IR | Quetiapine fumarate Immediate Release |
| BG001 | Quetiapine XR | Quetiapine fumarate Extended Release |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration. | Posted | Least Squares Mean | 95% Confidence Interval | units on scale | At 1 hour post-dose, Day 2 (50 mg) |
|
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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 IR | Quetiapine fumarate Immediate Release |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Quetiapine Extended Release | Drug | Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day |
|
|
| Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4) |
The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. |
| At 1 hour post-dose, Day 4 (200 mg) |
| Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | At 1 hour post-dose, Day 5 (300 mg) |
| Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | At 1 hour post-dose, Day 6 (300 mg) |
| Maximum Intensity Modified Bond-Lader Visual Analog Scale Score | The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments | During Day 2 (50 mg) |
| Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score | Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas | During Day 2 (50 mg) |
| Area Under the Modified Bond-Lader Visual Analog Scale-time Curve | Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose | During Day 2 (50 mg) |
| Change in Simpson-Angus Scale (SAS) Total Score | SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms. | Randomization to Day 7 |
| Change in Barnes Akathisia Rating Scale (BARS) Global Score | BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia. | Randomization to Day 7 |
| Change in Abnormal Involuntary Movement Scale (AIMS) Total Score | AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. | Randomization to Day 7 |
| Number of Patients With Potential Extrapyramidal Symptoms (EPS) | Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness | From start of the study treatment to last dose plus 30 days |
| Number of Patients With Potential Somnolence | Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence | From start of the study treatment to last dose plus 30 days |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Quetiapine XR |
Quetiapine fumarate Extended Release |
|
|
| Secondary | Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration. | Posted | Least Squares Mean | Standard Error | units on scale | At 1 hour post-dose, Day 3 (100 mg) |
|
|
|
| Secondary | Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration. | Posted | Least Squares Mean | Standard Error | units on scale | At 1 hour post-dose, Day 4 (200 mg) |
|
|
|
| Secondary | Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration. | Posted | Least Squares Mean | Standard Error | units on scale | At 1 hour post-dose, Day 5 (300 mg) |
|
|
|
| Secondary | Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6) | The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. | The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration. | Posted | Least Squares Mean | Standard Error | units on scale | At 1 hour post-dose, Day 6 (300 mg) |
|
|
|
| Secondary | Maximum Intensity Modified Bond-Lader Visual Analog Scale Score | The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments | The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration. | Posted | Least Squares Mean | Standard Error | units on scale | During Day 2 (50 mg) |
|
|
|
| Secondary | Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score | Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas | The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration. | Posted | Least Squares Mean | Standard Error | Hours | During Day 2 (50 mg) |
|
|
|
| Secondary | Area Under the Modified Bond-Lader Visual Analog Scale-time Curve | Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose | The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken. | Posted | Least Squares Mean | Standard Error | mm * hour | During Day 2 (50 mg) |
|
|
|
| Secondary | Change in Simpson-Angus Scale (SAS) Total Score | SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms. | The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken. | Posted | Mean | Standard Deviation | units on scale | Randomization to Day 7 |
|
|
|
| Secondary | Change in Barnes Akathisia Rating Scale (BARS) Global Score | BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia. | The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken. | Posted | Mean | Standard Deviation | units on scale | Randomization to Day 7 |
|
|
|
| Secondary | Change in Abnormal Involuntary Movement Scale (AIMS) Total Score | AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. | The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken. | Posted | Mean | Standard Deviation | units on scale | Randomization to Day 7 |
|
|
|
| Secondary | Number of Patients With Potential Extrapyramidal Symptoms (EPS) | Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness | The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken. | Posted | Number | Patients | From start of the study treatment to last dose plus 30 days |
|
|
|
| Secondary | Number of Patients With Potential Somnolence | Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence | Posted | Number | Patients | From start of the study treatment to last dose plus 30 days |
|
|
|
| 0 |
| 69 |
| 33 |
| 69 |
| EG001 | Quetiapine XR | Quetiapine fumarate Extended Release | 3 | 70 | 29 | 70 |
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
The PI agrees to collaborate in good faith with AstraZeneca with regards to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |