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

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.

Intervention(s) in this Clinical Trial

• Drug: Quetiapine Immediate Release
  • Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
• Drug: Quetiapine Extended Release
  • Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

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

• Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
  • Time Frame: At 1 hour post-dose, Day 2 (50 mg)
    Safety Issue?: No

Secondary Measures

• Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)
  • Time Frame: At 1 hour post-dose, Day 3 (100 mg)
    Safety Issue?: No
• Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)
  • Time Frame: At 1 hour post-dose, Day 4 (200 mg)
    Safety Issue?: No
• Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)
  • Time Frame: At 1 hour post-dose, Day 5 (300 mg)
    Safety Issue?: No
• Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)
  • Time Frame: At 1 hour post-dose, Day 6 (300 mg)
    Safety Issue?: No
• Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
  • Time Frame: During Day 2 (50 mg)
    Safety Issue?: No
• Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
  • Time Frame: During Day 2 (50 mg)
    Safety Issue?: No
• Area Under the Modified Bond-Lader Visual Analog Scale-time Curve
  • Time Frame: During Day 2 (50 mg)
    Safety Issue?: No
• Change in Simpson-Angus Scale (SAS) Total Score
  • Time Frame: Randomization to Day 7
    Safety Issue?: No
• Change in Barnes Akathisia Rating Scale (BARS) Global Score
  • Time Frame: Randomization to Day 7
    Safety Issue?: No
• Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
  • Time Frame: Randomization to Day 7
    Safety Issue?: No
• Number of Patients With Potential Extrapyramidal Symptoms (EPS)
  • Time Frame: From start of the study treatment to last dose plus 30 days
    Safety Issue?: No
• Number of Patients With Potential Somnolence
  • Time Frame: From start of the study treatment to last dose plus 30 days
    Safety Issue?: No

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 Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Catherine Datto, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 08, 2012

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