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

Phase 4

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: Quetiapine Immediate Release; Drug: Quetiapine Extended Release

• Registration Number: NCT00926393
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-05-04
• Results First Submitted QC: 2011-03-06
• Results First Posted: 2011-03-31
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-10
• Last Update Posted: 2011-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quetiapine Immediate Release (IR)	Quetiapine Immediate Release	Quetiapine 25, 100, 200 and 300 mg
Quetiapine Extended Release (XR)	Quetiapine Extended Release	Quetiapine 50, 200, 300

Primary Outcome Measures

Name	Time	Method
Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)	At 1 hour post-dose, Day 2 (50 mg)	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.

Secondary Outcome Measures

Name	Time	Method
Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)	At 1 hour post-dose, Day 3 (100 mg)	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.
Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)	At 1 hour post-dose, Day 4 (200 mg)	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.
Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)	At 1 hour post-dose, Day 5 (300 mg)	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.
Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)	At 1 hour post-dose, Day 6 (300 mg)	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.
Maximum Intensity Modified Bond-Lader Visual Analog Scale Score	During Day 2 (50 mg)	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
Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score	During Day 2 (50 mg)	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
Area Under the Modified Bond-Lader Visual Analog Scale-time Curve	During Day 2 (50 mg)	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
Change in Simpson-Angus Scale (SAS) Total Score	Randomization to Day 7	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.
Change in Barnes Akathisia Rating Scale (BARS) Global Score	Randomization to Day 7	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.
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score	Randomization to Day 7	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.
Number of Patients With Potential Extrapyramidal Symptoms (EPS)	From start of the study treatment to last dose plus 30 days	Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness
Number of Patients With Potential Somnolence	From start of the study treatment to last dose plus 30 days	Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence