Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) With Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalation in Patients With Bipolar Depression

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: Quetiapine Immediate Release
* Drug: Quetiapine Extended Release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed Outpatient status as enrollment Exclusion Criteria: Other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quetiapine Immediate Release (IR)<br>Quetiapine 25, 100, 200 and 300 mg | Drug: Quetiapine Immediate Release<br>* Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day<br>* Other names: Seroquel IR;|
| Active Comparator: Quetiapine Extended Release (XR)<br>Quetiapine 50, 200, 300 | Drug: Quetiapine Extended Release<br>* Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day<br>* Other names: Seroquel XR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inpatient, bipolar depression, quetiapine, Seroquel IR, Seroquel XR, safety, tolerability