Official Title: “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”

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

Study Type: Interventional

Study Design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: Quetiapine Immediate Release
  • Oral, 3 tablets daily
• Drug: Quetiapine Extended Release
  • Oral, 3 tablets daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Quetiapine Immediate Release (IR)
  • Quetiapine 25, 100 200 and 300 mg
• Active Comparator: Quetiapine Extended Release (XR)
  • Quetiapine 50, 200, 300

Primary Measures

• Visual Analog Scale
  • Time Frame: Daily during the 7 day inpatient treatment
    Safety Issue?: No

Secondary Measures

• Safety and Tolerability during initial titration period
  • Time Frame: Daily
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Catherine Datto, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00926393

Study ID Number: D1443C00040

ClinicalTrials.gov Identifier: NCT00926393

Health Authority: United States: Food and Drug Administration