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

NCT00926393 Phase 4 COMPLETED Results posted

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

Details

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	COMPLETED
Enrolment	139
Start date	2009-06
Completion	2009-08

Conditions

• Bipolar Depression

Interventions

• Quetiapine Immediate Release
• Quetiapine Extended Release

Primary outcomes

• 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.