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

AstraZeneca0 sites139 target enrollmentJune 2009

ConditionsBipolar Depression

InterventionsQuetiapine Immediate Release Quetiapine Extended Release

DrugsQuetiapine Immediate Release Quetiapine Extended Release

Overview

Phase: Phase 4
Intervention: Quetiapine Immediate Release
Conditions: Bipolar Depression
Sponsor: AstraZeneca
Enrollment: 139
Primary Endpoint: Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

August 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Arms & Interventions

Quetiapine Immediate Release (IR)

Quetiapine 25, 100, 200 and 300 mg

Intervention: Quetiapine Immediate Release

Quetiapine Extended Release (XR)

Quetiapine 50, 200, 300

Intervention: Quetiapine Extended Release

Outcomes

Primary Outcomes

Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)

Time Frame: 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 Outcomes

Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)(At 1 hour post-dose, Day 3 (100 mg))
Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)(At 1 hour post-dose, Day 4 (200 mg))
Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)(At 1 hour post-dose, Day 5 (300 mg))
Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)(At 1 hour post-dose, Day 6 (300 mg))
Maximum Intensity Modified Bond-Lader Visual Analog Scale Score(During Day 2 (50 mg))
Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score(During Day 2 (50 mg))
Area Under the Modified Bond-Lader Visual Analog Scale-time Curve(During Day 2 (50 mg))
Change in Simpson-Angus Scale (SAS) Total Score(Randomization to Day 7)
Change in Barnes Akathisia Rating Scale (BARS) Global Score(Randomization to Day 7)
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score(Randomization to Day 7)
Number of Patients With Potential Extrapyramidal Symptoms (EPS)(From start of the study treatment to last dose plus 30 days)
Number of Patients With Potential Somnolence(From start of the study treatment to last dose plus 30 days)